New: Legal/Compliance & Ethics Education Group

Are you a professional involved in Legal/Compliance & Ethics in the life science sector and interested to join this new Education Group as a volunteer?

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Flemish Recognition Commission for physicians on "Pharmaceutical Medicine/Clinical Pharmacology"

We want to congratulate the members of the newly established Flemish Recognition Commission for physicians on "Pharmaceutical Medicine/Clinical Pharmacology": Robert Lins, Bharati Shivalkar, Erik Present, Patricia Van Dijck, Jan de Hoon, Sylvie Rottey, Philippe Jorens and Alain Dupont.

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IFAPP Today newsletter - June 2024

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of June 2024, featuring the article 'Clinical Pharmacology and Pharmaceutical Medicine in Belgium: The Making of a New Specialist Title for Physicians' written by Erik Present (Healixia President), Robert Lins (Healixia Clinical Research Education Group member) & Jan de Hoon (Healixia board member).

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IFAPP Today newsletter - May 2024

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of May 2024.

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IFAPP Today newsletter - April 2024

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of April 2024.

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Healixia at the VFSO Pharma Career Day 2024

The Pharma Career Day is now the fifth edition of the job fair organized by VFSO in collaboration with various companies, pharmacists, associations, universities, etc.

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Unveiling the landscape of Medical Affairs in the BeNeLux: a collaborative survey by Healixia and NVFG

Healixia and NVFG collaborated on a survey, the first of its kind, unveiling the landscape of Medical Affairs in the BeNeLux with 118 professionals contributing their insights.

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IFAPP Today newsletter - March 2024

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of March 2024.

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IFAPP Today newsletter - February 2024

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of February 2024.

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New specialty for Medical Doctors in Belgium in Clinical Pharmacology/Pharmaceutical Medicine.

On February 9th, an interview with Jan de Hoon and Erik Present (board members Healixia) about this new specialty was published in Artsenkrant. 

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From our sponsors: QbD Chair for Precision Oncology Research in Glioblastoma extended for three years

The QbD Chair supports the research of Professor Frederik De Smet on glioblastoma, an aggressive form of brain cancer. Behind the establishment of this chair lies a personal story.

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IFAPP Today newsletter - January 2024

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of January 2024.

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Breaking News: “Pharmaceutical Medicine/Clinical Pharmacology”: new specialty for MDs in Belgium.

On Oct 31st, the Ministerial Decree was published regarding the creation of a new specialty for Medical Doctors in Belgium: physician-specialist in Pharmaceutical Medicine/Clinical Pharmacology.

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Healixia Clinical Conference 2023

On Thursday October 19^th 2023, we held our yearly Healixia Clinical Conference at Frame21 in Zaventem. We look back at another amazing edition with inspiring talks and interactions, approaching clinical research from different perspectives with one common goal: helping patients.

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IFAPP Today newsletter - October 2023

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of October 2023.

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Energizing Strategic meeting!

On September 14^th, our board & education group members gathered for our yearly strategic meeting, discussing Healixia’s vision, focus and future actions.

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The QbD Group acquires life sciences consultancy Azierta

Azierta, a life sciences and health consultancy located in Madrid and counting 70 multi-skilled employees, has joined the QbD Group.

Source: QbD

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Customs and the FAMHP seize 1.5 tonnes of illegal medicines

On 14 July 2023, customs and the FAMHP seized 1.5 tonnes of illegal medicines at Brucargo. This is one of the largest seizures in the European Union in recent years.

Source: FAMHP

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IFAPP Today newsletter - September 2023

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of September 2023.

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IN MEMORIAM Noël Wathion

Just over a year ago, we were honored to hand over to Noël Wathion the first Healixia award for his outstanding contribution to the pharmaceutical landscape. Today, we unfortunately have to say goodbye to this inspiring man.

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IFAPP Today newsletter - July/August 2023

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of July/August 2023.

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Unavailability of Hydrea 500 mg hard caps. 20: derogation and strategic stock

In het kader van de onbeschikbaarheid van het geneesmiddel Hydrea 500 mg harde caps. 20 werd een strategische stock aangekocht door de overheid. Een deel van deze strategische stock is vanaf 13 juli 2023 beschikbaar voor distributie. Volgende leveringen worden nog verwacht in de volgende weken.

Dans le cadre de l'indisponibilité du médicament Hydrea 500 mg x 20 gélules, un stock stratégique a été acheté par le gouvernement. Une partie de ce stock stratégique est disponible pour distribution à partir du 13 juillet 2023. Des livraisons ultérieures sont encore attendues dans les semaines suivantes.

Source: FAMHP

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Quality Innovation Group - Listen and Learn Focus Group hybrid meeting -12 & 13 October 2023 - Call for Abstract

The Quality Innovation Group (QIG) has been established by the EU Regulatory Network with the aim of supporting the translation of innovative approaches for the development, manufacture and quality control of medicines to the benefit of patients. These include, but are not limited to, innovative technologies, digitalization, novel materials and novel devices, in line with network priorities highlighted in the EMA Regulatory Science Strategy to 2025. Further details on QIG can be found on the group webpage and on the related press release.

Source: Quality Innovation Group

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Sale and use of antibiotics in animals in Belgium: a record decrease in 2022

In 2022 daalde de verkoop van antibiotica bij dieren sterk ten opzichte van 2021: een kwart minder voor de totale verkoop,  een derde minder voor de met antibiotica gemedicineerde voeders en meer dan de helft minder voor colistine. 

En 2022, la vente d’antibiotiques chez les animaux en Belgique a fortement diminué par rapport à 2021 : un quart de moins pour la vente totale, un tiers de moins pour les aliments médicamenteux avec antibiotiques et plus de la moitié de moins pour la colistine.

Source: FAMHP

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Derogation for Hydrea 500 mg hard caps. 20: recommendations for doctors (specialists) and pharmacists

In het kader van de onbeschikbaarheid van het geneesmiddel Hydrea 500 mg harde caps. 20 kent het FAGG een derogatie toe aan de vergunninghouder.

Dans le cadre de l'indisponibilité du médicament Hydrea 500 mg x 20 gélules, l'AFMPS accorde une dérogation au titulaire de l'autorisation de mise sur le marché.

Source: FAMHP

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The FAMHP publishes its annual report 2022

Although the FAMHP's staff continued to feel the effects of the health crisis, in 2022 they were also able to complete many tasks that had been postponed due to the coronavirus crisis. Various “major” files were started, followed up or closed. For example, new initiatives were launched in collaboration with other national and European institutions to combat the shortage of medicines in Belgium and the European Union.

Source: FAMHP

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IFAPP Today newsletter - June 2023

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of June 2023.

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Unavailability of Hydrea 500 mg hard caps. 20: recommendations for (hospital) pharmacists, doctors (specialists) and patients

Het geneesmiddel Hydrea 500 mg harde caps. 20 is onbeschikbaar in België tot 2 oktober 2023 door een vertraging in de productie. Een taskforce doet aanbevelingen.

Le médicament Hydrea 500 mg x 20 gélules restera indisponible en Belgique jusqu'au 2 octobre 2023 en raison d'un retard de production. Une task force émet des recommandations.

Source: FAMHP

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Survey of Healthcare Professionals on Ketoprofen in Gel Form: Fastum 2.5% Gel

In juni 2023 zal het FAGG een bevraging uitvoeren over ketoprofen in gelvorm (Fastum 2,5 % gel), in samenwerking met de "Division de la Pharmacie et des Médicaments" van de bevoegde overheid van het Groothertogdom Luxemburg.

L’AFMPS réalisera une enquête sur le kétoprofène en gel (Fastum 2,5 % gel) en juin 2023, en collaboration avec la Division de la pharmacie et des médicaments de l’autorité compétente du Grand-Duché du Luxembourg.

Source: FAMHP

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Info session for sponsors on early phase clinical trials on 15 September 2023

In the context of the new clinical trials regulations (CTR), on 15 September 2023,the FAMHP is organising an information session on early phase clinical trials.

Source: FAMHP

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News from our sponsor QbD

Source: IFAPP

QbD acquires Turnstone and Michor.

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IFAPP Today newsletter - May 2023

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of May 2023.

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Interview with our President Erik Present in PharmaBoardroom

PharmaBoardroom, the global platform for healthcare and life science executives, published an interview with our President, Erik Present in April 2023. 

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IFAPP Today newsletter - April 2023

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of April 2023.

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EFPIA has updated his scorecard regarding max. amounts for food & drinks

According to Art.10.05 of the EFPIA Code, Member Companies must not provide or offer any meal (food and beverages) to HCPs, HCOs’ members or POs’ Representatives, unless, in each case, the value of such meal does not exceed the monetary threshold set by the relevant Member Association in its National Code (following the “Host Country Principle”). 

Source: EFPIA

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Reform of medicines reimbursement procedures by Riziv-Inami

We werken aan een vernieuwend geneesmiddelenbeleid om een duurzame en toekomstbestendige toegankelijkheid van waardevolle farmaceutische specialiteiten voor patiënten in België te garanderen. Dit omvat een optimalisatie van de verschillende schakels voor alle betrokken stakeholders in het geneesmiddelenbeleid.

Depuis 2022, nous sommes en train d’élaborer une politique innovante en matière de médicaments, dans le but de garantir aux patients un accès durable à des spécialités pharmaceutiques de qualité en Belgique. Il s‘agit notamment d’optimiser les différents « maillons » pour tous les intervenants impliqués dans la politique des médicaments.

Source: Riziv-Inami

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Extension of transition period for the European Regulations for medical devices and for in-vitro diagnostics

Vandaag besliste de Raad van Europa en het Europese Parlement om een langere overgangsperiode te voorzien om aangemelde instanties (notified bodies) en fabrikanten meer tijd te geven om medische hulpmiddelen te certificeren en zo het risico van tekorten te beperken zodat patiënten in nood toegang blijven houden tot medische hulpmiddelen.

Aujourd'hui, le Conseil de l'Europe et le Parlement européen ont décidé de prévoir une période de transition plus longue afin de donner aux organismes notifiés (notified bodies) et aux fabricants plus de temps pour certifier les dispositifs médicaux, réduisant ainsi le risque de pénurie afin que les patients qui en ont besoin continuent d'avoir accès aux dispositifs médicaux.  

Source: FAMHP

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New system for financing the surveillance of the medical devices market

A new system for financing the surveillance of the medical devices market applies from 2023. This system aims to make fees fairer between the different stakeholders in the sector, as each one must pay a fee that is consistent with its turnover and with the level of risk involved in its activity and in the workload it represents for the FAMHP.  

Source: FAMHP

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IFAPP Today newsletter - March 2023

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of March 2023.

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PRAC February 2023 – Start of a safety review of pseudoephedrine-containing medicines

During its February 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has started a review of medicines containing pseudoephedrine.

Source: FAMHP

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Healixia award 2023: nominations

The Healixia Award is a new yearly tradition that was introduced in 2022. As a community of professionals, it is important to keep up with what is happening within our sector, in all the different domains we represent. Via this award, we want to honor a professional who made or makes a major contribution to our life science eco-system in Belgium and the mission of our organization.

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Mandatory application for export in the event of unavailability of essential medicines

De federale regering heeft een koninklijk besluit genomen waardoor de uitvoer van geneesmiddelen tijdelijk kan worden beperkt. Het besluit laat toe een de export in geval van onbeschikbaarheid te onderwerpen aan een voorafgaandelijke toelating, als het over essentiële geneesmiddelen gaat en aan bepaalde voorwaarden is voldaan.

Le gouvernement fédéral a pris un arrêté royal autorisant une restriction temporaire à l'exportation de médicaments. L'arrêté permet de soumettre les exportations en cas d'indisponibilité, lorsqu'il s'agit de médicaments essentiels et si certaines conditions sont remplies, à une autorisation préalable.

Source: FAMHP

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Five new drug precursors added to list of scheduled substances

The European Commission's new Delegated Regulation (EU) 2023/196 adds five drug precursors to the list of scheduled substances. These are substances that can be used to produce fentanyl or amphetamines. The trade, possession and use of these substances are subject to governmental supervision. The regulation enters into force on 20 February 2023.

Source: FAMHP

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IFAPP Today newsletter - February 2023

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of February 2023.

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End of the validation procedure for SARS-CoV-2 antigen self-tests

The validation procedure for SARS-CoV-2 antigen self-tests with a CE-marking ceased to apply since 23 January 2023. The associated list of recommended SARS-CoV-2 antigen self-tests with a CE-marking is therefore no longer available.

Source: FAMHP

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PRAC January 2023 - recommendations for Janus kinase (JAK) inhibitors and information about Zolgensma

Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors
EMA’s safety committee (PRAC) has further reviewed measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.

Source: FAMHP

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IFAPP Today newsletter - January 2023

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of January 2023.

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COVID-19: Audit Hospitals re-estimates hospital care not provided

Deze audit onderzoekt de niet-uitgevoerde ziekenhuiszorg en gecumuleerde potentiële zorgachterstanden vanaf het begin van de pandemie tot en met de zesde golf (van mei 2021 tot en met mei 2022). 

L’audit porte sur les soins non effectués et les retards accumulés dans les hôpitaux depuis le début de la pandémie jusqu’à la sixième vague incluse (de mai 2021 à mai 2022).

Source: FAMHP

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IFAPP virtual training workshop: Introduction to the new EU Clinical Trial Regulation

From 31 January 2023 all clinical trials with medicines must be authorised, handled and reported according to the rules lined out in the Regulation EU No 536/2014 (Clinical Trials Regulation).

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Indexation of hospitality amounts, fees to apply for Mdeon visum and sponsoring virtual and hybrid meetings.

As from January 1st, 2023, a number of novelties will take effect regarding the amounts for hospitality, the amounts of the fees to apply for an Mdeon visum and the sponsoring of virtual and hybrid meetings.

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Healixia Clinical Conference 2022: full report now available for download!

Our Clinical Conference on October 20^th 2022 was a success and we are happy to share a bit of it with you!

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Belgium publishes the first report on antimicrobial resistance

Antimicrobiële resistentie, ook AMR genoemd, is één van de grootste bedreigingen voor de volksgezondheid. Daarom werd in samenwerking met verschillende Belgische autoriteiten een nationaal actieplan ontwikkeld. België publiceert het eerste “One Health”-rapport over AMR om de resultaten samen te vatten.

La résistance aux antimicrobiens, également appelée AMR, est l’une des principales menaces pour la santé publique. C’est pourquoi un plan national d’action a été développé en collaboration avec différentes autorités belges. La Belgique publie aujourd’hui son premier rapport « One Health » sur l’AMR pour synthétiser les résultats.

Source: FAMHP

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Medical Affairs survey in collaboration with NVFG

Fill out the survey aims to map, for the first time in Benelux, the Medical Affairs professional and collect insight on demographics, role & responsibilities, education and other aspects. Target audience are Medical Advisors, Medical Science Liaisons and other Medical Affairs professionals; active in Benelux.

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Operation Shield III: Belgian authorities seize 145,054 illegal products in action against counterfeit drugs and doping

De Douane, de Federale Politie, het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) en het Federaal Agentschap voor de Veiligheid van de Voedselketen (FAVV) hebben deelgenomen aan operatie SHIELD III, gecoördineerd door Europol. Deze actie liep van april tot oktober 2022 en was gericht tegen namaakgeneesmiddelen en doping.

Les douanes, la police fédérale, l'Agence fédérale des médicaments et des produits de santé (AFMPS) et l'Agence fédérale pour la sécurité de la chaîne alimentaire (AFSCA) ont participé à l'opération SHIELD III, coordonnée par Europol. Cette opération s'est déroulée d'avril à octobre 2022 et visait les médicaments contrefaits et le dopage.

Source: FAMHP

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FAMHP reminds of need for customer declaration for buyers of category 1 or 2 chemicals

Distributors and vendors of category 1 or 2 chemicals must require the buyer to provide a customer declaration of specific use. This is legally required by Regulation (EC) No 273/2004 and aims to protect trade in drug precursors (substances that can be used to make drugs).

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PRAC December 2022 – Recommendation of withdrawal of pholcodine medicines from European market

During its December 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has concluded its review of medicines containing pholcodine and has recommended the revocation of the European marketing authorisations for these medicines.

Source: FAMHP

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IFAPP Today newsletter - November/December 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of November/December 2022.

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Coronavirus: overview of side effects of COVID-19 vaccines from November 24, 2022

Meldingen van vermoedelijke bijwerkingen hebben bijgedragen tot een betere kennis van het veiligheidsprofiel van deze vaccins. Het FAGG blijft wil de melders bedanken en het melden van ernstige bijwerkingen blijven aanmoedigen om de vaccins beter te kunnen karakteriseren. Het FAGG heeft wel beslist om vanaf 2023 geen cumulatieve overzichten van gemelde bijwerkingen van COVID-19-vaccins meer te publiceren.

Les notifications d’effets indésirables suspectés, rapportées notamment à l’AFMPS, ont participé à l’amélioration de la connaissance de leur profil de sécurité. L’AFMPS veut remercier les notificateurs et continue d’encourager la notification d’effets indésirables graves afin de mieux les caractériser. L’AFMPS a décidé d’arrêter la publication des aperçus cumulatifs des effets indésirables des vaccins contre la COVID-19 à partir de 2023. 

Source: FAMHP

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Simultaneous national scientific advice pilot project: launch of phase 2

The European Innovation Network (EU IN) has launched phase 2 of the simultaneous national scientific advice (SNSA) pilot project. SNSA can be used when an applicant wants to obtain national scientific advice from more than one national competent authority (NCA) at the same time. 

Source: FAMHP

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PRAC November 2022 – Measures for Janus kinase inhibitors, modified product information of mRNA COVID-19 vaccines Comirnaty and Spikevax, and addition of warning to the product information for ustekinumab (Stelara)

During its November 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders. Furthermore, the PRAC recommended to add heavy menstrual bleeding to the product information as a side effect of the mRNA COVID-19 vaccines Comirnaty and Spikevax, and to add a warning to the product information for ustekinumab (Stelara).

Source: FAMHP

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MedSafetyWeek 2022: annual campaign to promote adverse reactions reporting

The global MedSafetyWeek runs from 7 to 13 November 2022. During this annual social media campaign, the FAMHP is also encouraging everyone to report suspected adverse reactions to medicinal products.

Source: FAMHP

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PRAC October 2022 – New measures for terlipressin-containing medicines and change to product information for combination of medicines with codeine and ibuprofen

During its October 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended new measures for terlipressin-containing medicines and has also recommended a change to the product information for codeine with ibuprofen combination medicines. The PRAC also discussed direct healthcare professional communications (DHPCs) containing important safety information for terlipressin-containing medicines and Imbruvica.

Source: FAMHP

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Amended legislation: drug precursors added to list of scheduled substances

The European Commission's new Delegated Regulation (EU) 2022/1518 adds two drug precursors to the list of scheduled substances. The regulation entered into force on 3 October 2022.

Source: FAMHP

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IFAPP Today newsletter - October 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of October 2022.

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Flash VIG-news : Dispensation of pholcodine-containing medicinal products suspended due to the risk of allergic cross-reactivity with neuromuscular blocking agents

Due to concerns about the risk of anaphylactic reactions, the dispensation of pholcodine-containing medicinal products is suspended from 1 October 2022.

Source: FAMHP

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Limited availability of thrombolytics: recommendations for hospital pharmacists and specialist physicians.

België wordt net als andere Europese landen geconfronteerd met kritieke beschikbaarheidsproblemen van trombolytica, dat zijn geneesmiddelen om bloedstolsels op te lossen. Het FAGG doet aanbevelingen rond het rationeel gebruik van deze geneesmiddelen en prioritisering van indicaties. De stock binnen de ziekenhuizen wordt opgevolgd en een noodvoorraad zal worden voorzien. 

À l’instar d’autres pays européens, la Belgique est confrontée à des problèmes de disponibilité critique de thrombolytiques (médicaments servant à dissoudre les caillots sanguins). L’AFMPS formule des recommandations sur l’usage rationnel de ces médicaments et la priorisation d’indications. Le stock hospitalier fait l’objet d’un suivi et un stock d’urgence sera constitué. 

Source: FAMHP

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Ozempic: recommendations for doctors (specialists) and (hospital) pharmacists due to limited availability

There is limited availability of the medicine Ozempic (semaglutide-based solution for subcutaneous injection) due to an acute increase in demand.  This limited availability will certainly last until early 2023.  Experts from the FAMHP's Unavailability Task Force give recommendations. 

Source: FAMHP

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Warning against the use of illegal TKTX ointment after applying tattoos

The FAMHP wants to warn consumers in Belgium not to use TKTX ointment, an illegal pain-relieving cream. It is mainly used to alleviate pain when applying a tattoo, permanent make-up ... TKTX ointment is not licensed in Belgium or Europe and therefore no guarantees can be given with regard to the composition, safety, quality or efficiency of this illegal medicine.

Source: FAMHP

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PRAC September 2022 –Reviews of topiramate and pholcodine medicines started

During the September 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral of topiramate and also started a referral of pholcodine medicines.

Source: FAMHP

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IFAPP Today newsletter - September 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of September 2022.

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Coronavirus: overview of side effects COVID-19 vaccines from August 25, 2022

Het volgende cumulatief overzicht van de bijwerkingen die zijn gemeld na toediening van een COVID-19-vaccin in België zal worden gepubliceerd op 24 november 2022.

Le prochain aperçu cumulatif des effets indésirables signalés suite à l'administration d'un vaccin contre la COVID-19 en Belgique sera publié le 24 novembre 2022. 

Source: FAMHP

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The FAMHP is looking for a new administrator-general

The mandate of Xavier De Cuyper, administrator-general of the FAMHP has ended. Xavier De Cuyper has been the agency's top manager since 2007 and has reached the age limit for holding a mandate within the federal government. A new selection procedure to appoint his successor was published by the Federal Government Selection Office (Selor).

Source: FAMHP

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Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the 2022-2026 workplan of the Accelerate Clinical Trials in the EU (ACT EU) initiative. The workplan has been prepared based on the recommendations of the European medicines agencies network strategy to 2025 and the European Commission’s Pharmaceutical Strategy for Europe.

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Call for candidates pilot project “e-PIL”: paper leaflet makes way for electronic leaflet

The FAMHP supports the pilot project “e-PIL” initiated by the pharmaceutical industry in Belgian and Luxembourg hospitals. In the context of this project, the package leaflet of certain medicines on the market in Belgium and Luxembourg is no longer put on paper in the box of the medicine, but is only available online on controlled websites.

Source: FAMHP

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Call for Belgian laboratories to apply to become the European Union reference laboratory for in vitro diagnostic medical devices

The European Commission has launched a call for laboratories of Member States to apply to become European Union reference laboratories (EURLs) for in vitro diagnostic (IVD) medical devices. The possible designation of such EURLs is provided for in article 100 of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

Source: FAMHP

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IFAPP Today newsletter - July-August 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of July-August 2022.

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Unavailability of Caprelsa 100 mg 30 film-coated tablets: recommendations for specialist physicians and hospital pharmacists

Het geneesmiddel Caprelsa 100 mg 30 filmomhulde tabletten, dat wordt gebruikt in de oncologie, zal van 26 juli 2022 tot 9 september 2022 onbeschikbaar zijn in België. Het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) doet daarom aanbevelingen.

Le médicament Caprelsa 100 mg 30 comprimés pelliculés, utilisé en oncologie, sera indisponible en Belgique du 26 juillet 2022 au 9 septembre 2022. L'Agence fédérale des médicaments et des produits de santé (AFMPS) émet donc des recommandations.

Source: FAMHP

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PRAC July 2022 – New measures for medicinal products containing nomegestrol or chlormadinone and start of assessment of neurodevelopmental disorders when using topiramate

During its July 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA)  recommends new measures to minimise the risk of meningioma with medicines containing nomegestrol or chlormadinone. The PRAC also starts the review on the risk of neurodevelopmental disorders with topiramate.

Source: FAMHP

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Antibiotics: amoxicillin for injection/infusion again available under the trade name Delamoxyle

The availability of appropriate antimicrobial medicines is important to fight antimicrobial resistance. The FAMHP strives to keep or to bring essential antimicrobial products on the market and to keep healthcare professionals and patients well informed. Again, as a result of those efforts:  amoxicillin for injection/infusion has been back on the market in Belgium since April.

Source: FAMHP

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The online medicinal products database gets an update

The FAMHP online medicinal products database contains information on all medicinal products for human and veterinary use authorised in Belgium. Some new functions have been added in this new version. This makes it easier to search for new medicinal products or active ingredients.

Source: FAMHP

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The FAMHP publishes its annual report for 2021: all figures and results, trends, activities related to COVID-19 and testimonials from our staff

2021 was the year we gradually returned to our normal way of working at the FAMHP. The high workload caused by the pandemic remained present, but numerous other important projects awaited us, such as the implementation of several European legislations. In addition to the traditional facts and figures, the 2021 annual report includes testimonials that demonstrate the commitment and professionalism of our staff.  

Source: FAMHP

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The FAMHP launches the Medicinal Product Management database: updating data in existing medicinal product databases temporarily not possible

On 4th of July 2022, the FAMHP launches the Medicinal Product Management database, a new internal database for medicinal products. Due to the launch, it will be temporarily impossible to update the data in the existing medicinal product databases.

Source: FAMHP

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Flash VIG-news: Nifuroxazide: important information on the use in pregnancy and lactation, mutagenicity and carcinogenicity

Uit voorzorg mag nifuroxazide niet worden toegediend tijdens de zwangerschap en de borstvoeding.  Bij vrouwen die zwanger kunnen worden, mag nifuroxazide alleen worden gebruikt als zij effectieve anticonceptie gebruiken.

Par mesure de précaution, le nifuroxazide ne doit pas être administré pendant la grossesse et l'allaitement. Le nifuroxazide ne doit être utilisé chez les femmes en âge de procréer que si elles utilisent une contraception efficace. 

Source: FAMHP

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Sleeping pills: survey by the FAMHP shows that more than a third of patients show signs of dependence

Meer dan achthonderd patiënten hebben deelgenomen aan een online bevraging van het FAGG over het gebruik van benzodiazepines en aanverwante geneesmiddelen bij slaapstoornissen. De bevraging toont aan dat de meeste patiënten deze geneesmiddelen te lang gebruiken. Meer dan een derde vertoont psychologische tekenen van afhankelijkheid. 

Plus de huit cent patients ont participé à une enquête en ligne de l’AFMPS sur la consommation de benzodiazépines et de médicaments apparentés utilisés dans le cadre des troubles du sommeil. L’enquête montre que la plupart des patients consomment ces médicaments pendant trop longtemps. Plus d’un patient sur trois montre des signes de dépendance psychologique. 

Source: FAMHP

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PRAC June 2022 –Update of COVID-19 vaccins and new safety information for Xalkori.

During its June 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA)  is continuing its assessment of cases of heavy menstrual bleeding (heavy periods) with the COVID-19 mRNA vaccines and the PRAC finds no link between mRNA COVID-19 vaccines and absence of menstruation. The PRAC also discussed a direct healthcare professional communication (DHPC) containing important safety information for Xalkori.

Source: FAMHP

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Request to marketing authorisation holders to send the approved version of the risk management plan

The Vigilance Division of the FAMHP requests marketing authorisation holders to send the approved version of the risk management plan for medicinal products for human use with a national marketing authorisation.

Source: FAMHP

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IFAPP Today newsletter - June 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of June 2022.

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Coronavirus: monthly update of COVID-19 vaccines 2 June 2022

Coronavirus: maandelijks overzicht bijwerkingen COVID-19-vaccins van 2 juni 2022

Coronavirus : aperçu mensuel des effets indésirables des vaccins contre la COVID-19 du 2 juin 2022

Source: FAMHP

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Update on the safety notifications about CPAP, BiPAP and ventilator devices manufactured by Philips

Extensive analyses of Philips' CPAP, BiPAP and ventilator devices have not revealed toxicologically relevant levels of volatile organic compounds. Nevertheless, no risk can be excluded at this time: patients are advised to consult their physician about the further course of their treatment.

Source: FAMHP

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Coronavirus: the Belgian guideline for the management of clinical trials during the coronavirus pandemic no longer applies

Due to the ending of the epidemiological emergency situation on 10 March 2022, the Belgian guideline to assist sponsors in the management of clinical trials during the coronavirus pandemic no longer applies. From now on, the rules in force will be applied and any deviation must be requested by providing a clear description of the situation. 

Source: FAMHP

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New antimicrobial drugs available in Belgium: Colistineb, Zerbaxa, Broxil and Rukobia. Important for patients and for the fight against antimicrobial resistance.

De beschikbaarheid van geschikte antimicrobiële middelen zorgt ervoor dat artsen meer mogelijkheden hebben om de beste behandeling te voorzien voor hun patiënten. Het is ook belangrijk in de strijd tegen antimicrobiële resistentie. Colistineb, Zerbaxa, Broxil en Rukobia zijn  antimicrobiële geneesmiddelen die recent beschikbaar werden in België.

La disponibilité des médicaments antimicrobiens appropriés donne aux médecins davantage de possibilités de fournir le meilleur traitement à leurs patients. Elle est également importante dans la lutte contre la résistance aux antimicrobiens. Colistineb, Zerbaxa, Broxil et Rukobia sont des médicaments antimicrobiens qui ont récemment été mis sur le marché en Belgique.

Source: FAMHP

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Call for tender by the European Commission: reservation of manufacturing capacities and priority right to manufacture vaccines

The European Commission has launched a call for tender to conclude single (consortium) framework contracts to reserve manufacturing capacities and obtain a priority right to manufacture vaccines in case of a future public health emergency. The project is called EU FAB.

Source: FAMHP

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PRAC May 2022 – Discussion regarding a direct healthcare professional communication (DHPC) containing important information for Defitelio

During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) discussed a direct healthcare professional communication (DHPC) containing important information for Defitelio. 

Source: FAMHP

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Online training: Managing and reporting serious breaches of the EU Clinical Trial Regulation

New Online Training from Brookwood Global, on demand.
Do it anywhere! Log in at any time 24/7, 365 days a year.

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IFAPP Today newsletter - May 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of May 2022, in which Healixia is featured!

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EU announces “A European Health Data Space for people and science” and puts patients in control of their healthdata

Today, the European Commission launched the European Health Data Space (EHDS), one of the central building blocks of a strong European Health Union. The EHDS will help the EU to achieve a quantum leap forward in the way healthcare is provided to people across Europe.

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Coronavirus: monthly update of COVID-19 vaccines 28 April 2022

Coronavirus: maandelijks overzicht bijwerkingen COVID-19-vaccins van 28 april 2022

Coronavirus : aperçu mensuel des effets indésirables des vaccins contre la COVID-19 du 28 avril 2022

Source: FAMHP

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Impact of war in Ukraine on clinical trials

The current war in Ukraine has had a huge impact on clinical trials in Ukraine, Russia and Belarus. Due to the war, a large number of patients in these countries participating in clinical trials are no longer able to participate. There are also problems with the supply of medicinal products and other supplies for conducting clinical trials.

Source: FAMHP

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NVFG Medical Affairs Day on May 12th, 2022

NVFG (Nederlandse Vereniging van Farmaceutisch Geneeskunde) organises a full day dedicated to Medical Affairs (Veenendaal, May 12th, from 9 to 18 hrs) under the umbrella “De patiënt centraal” (the symposium will be in Dutch). 

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PRAC April 2022 – No causal association found between the COVID-19 vaccines Comirnaty and Spikevax and autoimmune hepatitis

During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that available evidence does not support a  causal link between COVID-19 vaccines Comirnaty and Spikevax and very rare cases of autoimmune hepatitis. 

Source: FAMHP

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IFAPP Today newsletter - April 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of April 2022.

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Extension of the EU pilot project on simultaneous national scientific advice

The Head of Medicines Agencies has approved the extension of the European pilot project for simultaneous national scientific advice at its 107th meeting in February 2022. The approval followed a positive evaluation of the first results of the project since its launch in February 2020.

Source: FAMHP

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Accelerated scientific-technical advice on medicines against COVID-19

Since the start of the COVID-19 health crisis, the FAMHP has given the highest priority to requests for national scientific-technical advice (STA) on medicines against COVID-19. The National Innovation Office and Scientific-Technical Advice Unit uses accelerated timelines for requests regarding medicines that prevent or cure COVID-19 infections. These timelines are crucial to support accelerated clinical research on new medicines against COVID-19.

Source: FAMHP

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Coronavirus: monthly update of COVID-19 vaccines 24 March 2022

Coronavirus: maandelijks overzicht bijwerkingen COVID-19-vaccins van 24 maart 2022

Coronavirus : aperçu mensuel des effets indésirables des vaccins contre la COVID-19 du 24 mars 2022

Source: FAMHP

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Genotoxic medicines and contraception: recommendations for all genotoxic active substances, regardless of therapeutic indication

The European Medicines Agency's Safety Working Party clarifies its recommendations on genotoxic medicines and the duration of contraception to apply to any genotoxic active substance, regardless of its therapeutic indication. 

Source: FAMHP

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Call for an important projects of common European interest in the health sector

The FPS Economy published a call for interest from the Belgian federal and regional authorities for important projects of common European interest. The call is intended for economic operators who wish to take part in innovative projects at European level through various partnerships. The first documents should be sent by 30 March 2022 at the latest.

Source: FAMHP

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Fight against antibiotic resistance: Amukin (amikacin) available again

Het FAGG doet inspanningen om essentiële antibiotica op de markt te houden of te brengen. Een positief resultaat daarvan is dat Amukin na drie jaar afwezigheid op de markt nu opnieuw beschikbaar is. 

Bron: FAGG

L'AFMPS s'efforce de maintenir ou de mettre sur le marché des antibiotiques essentiels. Cet effort a notamment conduit à un résultat important : Amukin est à nouveau disponible après trois ans d'absence du marché.

Source: AFMPS

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PRAC March 2022 – Update on COVID-19 vaccines and new safety information for dexmedetomidine

During its March 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has recommended a change to the product information for the COVID-19 vaccines of Janssen and Moderna. The Committee also discussed a direct healthcare professional communication containing important safety information for dexmedetomidine.

Source: FAMHP

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Message from the IFAPP President

An update on the collaboration between IFAPP and IFAPP Academy 

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IFAPP Today newsletter - March 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of March 2022.

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The FAMHP encourages non-profit organisations and academia to apply for the pilot project for the repurposing of authorised medicines

The FAMHP takes part in the European pilot project for the repurposing of medicines to support non-profit organisations and academia. The project was launched by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).

Source: FAMHP

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Healixia is looking for a Director

Two years after the start of Healixia, we are ready for the next step. We want to further establish our growth and are looking for a Director to help us do so. Are you interested or do you know someone who might be?

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Coronavirus: monthly update of COVID-19 vaccines 24 February 2022

Coronavirus: maandelijks overzicht bijwerkingen COVID-19-vaccins van 24 februari 2022

Coronavirus : aperçu mensuel des effets indésirables des vaccins contre la COVID-19 du 24 février 2022

Source: FAMHP

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The FAMHP publishes its 2020 annual report with testimonials about the first year of the pandemic

In addition to the usual facts and figures, the FAMHP's 2020 annual report includes testimonials from staff members who had to face difficult situations in the field. These stories show that there was tremendous stress and pressure, but also a lot of dedication and professionalism. 

Source: FAMHP

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PRAC February 2022

During its February 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended suspending hydroxyethyl-starch solutions for infusion from the market. Furthermore, the PRAC starts a safety review of Janus kinase inhibitors for inflammatory disorders.  

Source: FAMHP

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Derogation for sponsors of non-commercial clinical trials to adapt packaging/labelling of an investigational medicinal product that is on the market

The European Regulation 536/2014 (Clinical Trial Regulation, CTR) came into force on 31 January 2022 and allows the packaging/labelling of investigational medicinal products already on the market not to be adapted for the clinical trial, except under special circumstances.  

Source: FAMHP

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Modification of the veterinary prescriptions and the administration and supply document

On 28 January 2022, the European Regulation on medicinal products for veterinary use has entered into force. Among other things, this implies that veterinarians have the obligation to use a new model format for veterinary prescriptions. These changes will take place in several phases. 

Source: FAMHP

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Studieavond leerstoel AHLEC op 23/02 - De nieuwe btw-regelgeving voor niet-therapeutische zorg

Op 1 januari 2022 werd de nieuwe wetswijziging met betrekking tot btw-vrijstellingen voor de medische sector van kracht.

Tijdens deze studieavond op 23 februari 2022 wordt er dieper ingegaan op de meest relevante btw-wijzigingen op basis van voorbeelden uit de praktijk. Tevens wordt er gefocust op enkele meer verdoken problemen waartegen vaak wordt gezondigd.

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IFAPP Today newsletter - February 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of February 2022.

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Don't forget the online form to report suspected side effects of animal treatments

In juni 2021 lanceerde het FAGG een praktisch en gebruiksvriendelijk onlineformulier waarmee iedereen vermoedelijke bijwerkingen (zowel bij mens als dier) van behandelingen bij dieren kan melden. 

En juin 2021, l’AFMPS a lancé un formulaire en ligne, pratique et facile à utiliser, grâce auquel chacun peut notifier des effets indésirables présumés (tant chez l’homme que chez l’animal) de traitements pour les animaux. 

Source: FAMHP

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New European rules on medicinal products for veterinary use as of 28 January 2022

As of 28 January 2022, Regulation 2019/6 became effective. From that moment onwards, European Member States must comply with all rules from this regulation.

Source: FAMHP

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Coronavirus: monthly update of COVID-19 vaccines 27 January 2022

Coronavirus: maandelijks overzicht bijwerkingen COVID-19-vaccins van 27 januari 2022

Coronavirus : aperçu mensuel des effets indésirables des vaccins contre la COVID-19 du 27 janvier 2022

Source: FAMHP

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Clinical trials: new European regulation enters into force

On 31 January 2022, the Clinical Trials Regulation (CTR) 536/2014 on medicinal products for human use will enter into force. However, the old and the new legislation on clinical trials will coexist during a transition period of three years (until 31 January 2025).

Source: FAMHP

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EMA: Information session for CTR stakeholders, 3rd February 10h-12h.

Joint action on support to coordinated and expedited assesment of clinical trials for COVID-19 therapeutics.

Click here to register.

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IFAPP Today newsletter - January 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of January 2022.

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PRAC January 2022 – Review of terlipressin medicines started, update of COVID-19 vaccins and new safety information for Mavenclad

During its January 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral of terlipressin medicines. The PRAC also has recommended a change to the product information for Vaxzevria and COVID-19 Vaccine Janssen. The PRAC discussed direct healthcare professional communication (DHPC) containing important safety information for Mavenclad.

Source: FAMHP

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Manufacturers, importers and distributors of human and veterinary medicines must check their data in the Organisation Management Service database of the EMA

From 28 January 2022, new regulations will come into force for manufacturers, importers and distributors of medicines for human and veterinary use. The FAMHP is asking them to check from 28 January 2022 onwards whether their organisation's data are correctly registered in the Organisation Management Service of the European Medicines Agency (EMA).

Source: FAMHP

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Give your opinion on a genetically modified medicine for the treatment of Duchenne muscular dystrophy

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SRP-9001 for the treatment of Duchenne muscular dystrophy. The public consultation runs from 17 January 2022 to 16 February 2022.

Source: FAMHP

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Give your opinion on a genetically modified medicine for the treatment of various types of advanced cancer

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial testing the genetically modified oncolytic virus VSV-GP (BI 1831169), for the treatment of patients with various types of advanced cancer (solid tumours). The public consultation runs from 11 January 2022 to 10 February 2022.

Source: FAMHP

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COVID-19 webinar update from Brazil: Critical Retrospective of the COVID-19 Pandemic in Brazil (2020-2021)

After the first webinar of its kind in December 2020, SBMF, the IFAPP member association from Brazil will provide a “Critical Retrospective of the COVID-19 Pandemic in Brazil” on 20 January 2022, 12:00-13:30 CET.

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Limited availability of RoActemra (Roche): new situation update

The availability of RoActemra (tocilizumab), a drug used for certain rheumatological and hematological disorders, can still not be fully guaranteed. Currently, there is a stock for both the intravenous and subcutaneous form of administration, taking into account the previously approved indications, i.e. exclusive use in COVID-19 patients. At present, Roche has only confirmed a limited number of deliveries for early January 2022.

Source: FAMHP

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Limited availability of subcutaneous immunoglobulins

Due to a decrease in the availability of subcutaneous immunoglobulins around the world, there is also a critical level of limited availability in Belgium. The FAMHP issues several recommendations for hospital and retail pharmacists, medical doctors (specialists), and patients.

Source: FAMHP

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Coronavirus: monthly update of COVID-19 vaccines 16 December 2021

Coronavirus: maandelijks overzicht bijwerkingen COVID-19-vaccins van 16 december 2021

Coronavirus : aperçu mensuel des effets indésirables des vaccins contre la COVID-19 du 16 decembre 2021

Source: FAMHP

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Reiteration of the recommendations for the rational use of benzodiazepines and “Z-drugs” in sleep disorders

Volgend op de publicatie van de resultaten van de vijfde COVID-19 gezondheidsbevraging van Sciensano en de FAGG-bevraging over het gebruik van slaapmiddelen, wil het FAGG patiënten en gezondheidszorgbeoefenaars aanmoedigen om benzodiazepines en "Z-drugs" correct te gebruiken bij slaapstoornissen.

Suite à la publication des résultats de la 5ème enquête de santé COVID-19 de Sciensano ainsi que de ceux de l’enquête de l’AFMPS sur l’utilisation des somnifères, l’AFMPS souhaite encourager patients et professionnels de la santé au bon usage des benzodiazépines et « Z-drugs » dans le cadre des troubles du sommeil.

Source: FAMHP

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Operation Shield II: Belgian authorities seize 87 241 tablets and 99 549 ampoules in action against counterfeit medicines and doping

De douane, de federale politie, het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) en het Federaal Agentschap voor de Veiligheid van de Voedselketen (FAVV) hebben deelgenomen aan operatie SHIELD II, gecoördineerd door Europol. 

La Douane, la Police fédérale, l’Agence fédérale des médicaments et des produits de santé (AFMPS) et l’Agence fédérale pour la sécurité de la chaîne alimentaire (AFSCA) ont participé à l'opération SHIELD II, coordonnée par Europol.

Source: FAMHP

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“Off-Label prescription” in Belgium.

In this month’s edition of Folia Pharmacotherapeutica, an overview has been published on “Off-Label prescription” in Belgium.

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IFAPP Today newsletter - nov/dec 2021

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of November/December 2021.

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PRAC December 2021 – Assessment of recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax

During the December 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has assessed recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax.

Source: FAMHP

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Second information session on the new Clinical Trial Regulation (CTR) on 15 December 2021

The FAMHP is organising the second information session on the new Clinical Trial Regulation (CTR) for sponsors and applicants of clinical trials on 15 December 2021 from 9 a.m. to 12 noon. The presentation and questions and answers of the first info session are now available.

Source: FAMHP

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Adjustment of the veterinary prescriptions in line with the European Regulation for veterinary medicines

Op 28 januari 2022 treedt de Europese Verordening voor diergeneesmiddelen in werking en gelden in elke Europese lidstaat dezelfde regels. Dierenartsen moeten vanaf dan onder meer een nieuw model van het diergeneeskundig voorschrift gebruiken.

Le 28 janvier 2022, le règlement européen relatif aux médicaments vétérinaires entrera en vigueur et les dispositions fixées par ce Règlement s’appliqueront dans chaque État membre européen. Cela signifie, entre autres, que les vétérinaires auront l’obligation d’utiliser un nouveau modèle de prescription vétérinaire à partir de cette date. 

Source: FAMHP

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Procedure for removal or addition of a patented indication for medicines for human use

The applicant or marketing authorisation holder for a generic medicine may decide not to include the patented indications or dosage forms in the marketing authorisation and not to mention them in the summary of product characteristics and package leaflet. Applicants/marketing authorisation holders must follow specific procedures to remove or reinsert the patented indication.

Source: FAMHP

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Give your opinion on genetically modified vaccines to treat hepatitis B

The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified vaccines ChAd155-hIi-HBV and MVA-HBV for the treatment of infections with the hepatitis B virus (HBV). The public consultation will run from 27 November 2021 to 27 December 2021.

Source: FAMHP

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12th International Symposium of Drug Analysis - 32nd International Symposium on Pharmaceutical and Biomedical Analysis

The Organising Committee of the International Symposium DA-PBA 2022 is pleased to announce its 2022 edition, which will take place in Mons, Belgium, from September 11-14, 2022. 

This symposium will be a joint meeting of two distinguished series: the 12th International Symposium on Drug Analysis and the 32nd International Symposium on Pharmaceutical and Biomedical Analysis.

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Clinical Trials Regulation (CTR): specific webinar for small and medium-sized enterprises (SMEs) and academic sponsors

In the context of the preparation of the implementation of the Clinical Trials Regulation (CTR), which will come into force on 31 January 2022, a specific webinar for SMEs and academic sponsors on key aspects of the CTR and the new processes via the Clinical Trials Information System (CTIS) for clinical trial application submissions will be organised on 29 November 2021.

Source: FAMHP

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Coronavirus: updated timelines for applications for COVID-19 clinical trials

Since 25 March 2020, shortened deadlines have been used for applications for clinical trials with medicinal products for the treatment or prevention of COVID-19. As the vaccination campaign has reached the majority of the population, these reduced timelines are now extended to 15 calendar days.

Source: FAMHP

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Coronavirus: monthly update of COVID-19 vaccines 18 November 2021

Coronavirus: maandelijks overzicht bijwerkingen COVID-19-vaccins van 18 november 2021

Coronavirus : aperçu mensuel des effets indésirables des vaccins contre la COVID-19 du 18 novembre 2021

Source: FAMHP

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International week of awareness for rational use of antibiotics

Van 18 tot 24 november 2021 loopt de internationale week van de sensibilisering voor rationeel gebruik van antibiotica.

La semaine mondiale de sensibilisation à l’usage rationnel des antibiotiques se déroule du 18 au 24 novembre 2021.

Source: FAMHP

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Deadlines for the submission of dossiers during end-of-year period

During the end-of-year period, the FAMHP will be closed from Monday 27 December 2021 through Friday 31 December 2021. Deadlines have been set for the submission of different types of dossiers.

Source: FAMHP

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PRAC November 2021: updates on COVID-19 vaccines and conclusion of safety signal for Imbruvica

During its November 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has made un update on COVID-19 vaccines and concluded a safety signal for Imbruvica.

Source: FAMHP

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MedSafetyWeek: help make vaccines safer by reporting suspected side effects

Het FAGG neemt samen met bevoegde autoriteiten uit 64 landen deel aan een internationale sociale mediacampagne die het belang van bijwerkingen na vaccinatie melden in de verf zet. 

L'AFMPS, en collaboration avec les autorités compétentes de 64 pays, participe à une campagne internationale sur les médias sociaux soulignant l'importance de déclarer les effets indésirables après une vaccination. 

Source: FAMHP

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Give your opinion on a genetically modified vaccine to treat colorectal cancer

The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified vaccine VSV-GP128 to treat colorectal cancer. The public consultation will run from 1 November 2021 to 1 December 2021.

Source: FAMHP

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Reinforcing Belgium’s Position as a Leading Global Biopharma Hub

Today, Prime Minister De Croo launched an action plan called “ Belgium, the Health and Biotech Valley of Tomorrow”. First step of this action plan is a report of Boston Consulting Group titled “Reinforcing Belgium’s Position as a Leading Global Biopharma Hub”.

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Coronavirus: monthly update of COVID-19 vaccines 21 October 2021

Coronavirus: maandelijks overzicht bijwerkingen COVID-19-vaccins van 21 oktober 2021

Coronavirus : aperçu mensuel des effets indésirables des vaccins contre la COVID-19 du 21 octobre 2021

Source: FAMHP

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FPM Annual Symposium

TRIALS and TRIBULATIONS 
Shaping a Bright New Future for Pharmaceutical Medicine

11-12 NOVEMBER 2021 - virtual conference

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APL online training ons Advertising, Transparency & Ethics

APL (Association Pharmaceutique Luxembourgeoise) organizes a training on Advertising, Transparency & Ethics: Thursday Nov 25th, from 12.00h to 14.00h.

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IFAPP Today newsletter

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of October 2021.

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Nomegestrol containing products and chlormadinone containing products and update on COVID-19 vaccines

During its October 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of meningioma risk with nomegestrol- and chlormadinone-containing medicines. The PRAC also has reviewed data on venous thromboembolism and immune thrombocytopenia with COVID-19 vaccines.

Source: FAMHP

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Modified invoicing for applications for national scientific-technical advice

From 1 October 2021, the FAMHP uses a new invoicing method for applications for national scientific-technical advice of types I, II and III that are treated by the National Innovation Office and Scientific-Technical Advice Unit.

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Sub-Saharan COVID-19 WEBINAR

IFAPP is honoured to announce the next free webinar on regional COVID-19 issues, in collaboration with Fundisa African Academy of Medicines Development. This webinar will be presented on 18 November 2021, at 2.00 pm CET.

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Efficiency gains through innovation in medicine development: how can science contribute ?

Today, the KNAW ( Koninklijke Academie voor Wetenschappen Nederland- Royal Dutch Academy of Science) issued a advise report titled “ Efficiency gains through innovation in medicine development: how can science contribute ?”.

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The Directorate-General PRE authorization is looking for a new Director-General

Het FAGG laat weten dat de functie van directeur-generaal DG PRE vergunning is open verklaard. 

L'AFMPS annonce que le poste de directeur général de direction générale PRE autorisation a été déclaré vacant.

Source: FAMHP

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Register now for the online information session on the new European veterinary medicines legislation on 15 October 2021

On 15 October 2021, the FAMHP is organising an online information session on the European Regulation 2019/6 regarding veterinary medicines. The information session is intended for people working in the Belgian pharmaceutical industry.

Source: FAMHP

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Nicotine pouches are no longer considered to be a medicinal product

In its new advice the Joint Commission states that nicotine pouches are no longer considered to be a medicinal product. When used normally, the usual doses (around 10 mg) do not pose a risk of poisoning. However, there are some recommendations for manufacturers. These concern the nicotine yield and the maximum daily dose, the use by children and therapeutic claims.

Source: FAMHP

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Coronavirus: biweekly update of COVID-19 vaccines 23 September 2021

Coronavirus: tweewekelijks overzicht bijwerkingen COVID-19-vaccins van 23 september 2021

Coronavirus : aperçu bimensuel des effets indésirables des vaccins contre la COVID-19 du 23 septembre 2021

Source: FAMHP

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Flu vaccine: 840,000 more doses available for the 2021-2022 flu season

Er zijn voor het nieuwe griepseizoen 3,78 miljoen griepvaccins beschikbaar. Dat is een kwart meer dan vorig jaar. Door die grotere beschikbaarheid is er dit jaar geen fasering voor de aflevering. Dat wil zeggen dat iedereen die dat wenst zich vanaf 15 oktober 2021 kan laten vaccineren.

3,78 millions de vaccins contre la grippe sont disponibles pour la prochaine campagne de vaccination, soit un quart de plus que l'année dernière. Cette disponibilité accrue permet l'abandon de la délivrance en phases. Cela signifie que quiconque le souhaite pourra se faire vacciner d'emblée dès le 15 octobre 2021.

Source: FAMHP

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Flash VIG news: rational use of benzodiazepines and “Z drugs” in sleep disorders

Volgend op de publicatie van de resultaten van de vijfde COVID-19 gezondheidsbevraging van Sciensano en de FAGG-bevraging over het gebruik van slaapmiddelen, wil het FAGG patiënten en gezondheidszorgbeoefenaars aanmoedigen om benzodiazepines en "Z-drugs" correct te gebruiken bij slaapstoornissen.

Suite aux publications des résultats de la cinquième enquête de santé COVID-19 de Sciensano ainsi que ceux de l’enquête de l’AFMPS sur l’utilisation des somnifères, l’AFMPS souhaite encourager patients et professionnels de la santé au bon usage des benzodiazépines et « Z-drugs » dans le cadre des troubles du sommeil.

Source: FAMHP

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Save the date: online information session about the new European legislation on veterinary medicines on 15 October 2021

Op 15 oktober 2021 organiseert het FAGG een online infosessie over de Europese Verordening 2019/6 rond diergeneesmiddelen. De infosessie is toegespitst op personen werkzaam in de Belgische farmaceutische industrie.

Le 15 octobre 2021, l'AFMPS organise une séance d'information en ligne sur le règlement européen 2019/6 relatif aux médicaments vétérinaires. La session d'information s'adresse aux personnes travaillant dans l'industrie pharmaceutique belge.

Source: FAMHP

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7 habits of a highly effective Medical Director

A recent article translates the principles of highly effective leaders to the profession of Medical Directors. Please find hereby a link to the article.

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IFAPP Today newsletter

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of September 2021.

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Coronavirus: biweekly update of COVID-19 vaccines 9 September 2021

Coronavirus: tweewekelijks overzicht bijwerkingen COVID-19-vaccins van 9 september 2021

Coronavirus : aperçu bimensuel des effets indésirables des vaccins contre la COVID-19 du 9 septembre 2021

Source: FAMHP

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Coronavirus: details of the renewed measures taken by the FAMHP to avoid shortages of medicines.

Het FAGG heeft een aantal maatregelen hernomen in een nieuw ministerieel besluit. Dit besluit werd opgesteld naar aanleiding van de crisiswet van 13 juni 2021 en om tekorten aan geneesmiddelen in het kader van de coronaviruspandemie (COVID-19) te kunnen blijven vermijden.

L'AFMPS a repris un certain nombre de mesures dans un nouvel arrêté ministériel. Cette décision a été élaborée à la suite de la loi du 13 juin 2021 et pour continuer à éviter les pénuries de médicaments dans le cadre de la pandémie de coronavirus (COVID-19).

Source: FAMHP

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Unavailability of RoActemra (Roche): update on the situation

RoActemra (tocilizumab), een geneesmiddel dat wordt gebruikt voor bepaalde reumatologische en hematologische aandoeningen, is momenteel wereldwijd onbeschikbaar. 

RoActemra (tocilizumab), un médicament utilisé pour traiter certaines affections rhumatismales et hématologiques, est actuellement indisponible dans le monde entier.

Source: FAMHP

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Coronavirus: new version of Belgian directive for management of clinical trials during coronavirus pandemic

A new version of the national directive is available to supplement the European guidelines (v3) for the management of clinical trials during the coronavirus pandemic.

Source: FAMHP

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Coronavirus: biweekly update of COVID-19 vaccines 26 August 2021

Coronavirus: tweewekelijks overzicht bijwerkingen COVID-19-vaccins van 26 augustus 2021

Coronavirus : aperçu bimensuel des effets indésirables des vaccins contre la COVID-19 du 26 août 2021

Source: FAMHP

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News from IFAPP

Paper on Promoting Best Practices for Medical Science Liaisons, Position
Statement from the APPA, IFAPP, MAPS and MSLS

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Fraudulent e-mails in the name of the FAMHP

Frauduleuze e-mails in naam van het FAGG

E-mails frauduleux au nom de l'AFMPS

Source: FAMHP

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Coronavirus: biweekly update of COVID-19 vaccines 12 August 2021

Coronavirus: tweewekelijks overzicht bijwerkingen COVID-19-vaccins van 12 augustus 2021

Coronavirus : aperçu bimensuel des effets indésirables des vaccins contre la COVID-19 du 12 août 2021

Source: FAMHP

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PRAC August 2021 – Recommendation and review of safety issues related to COVID-19 vaccines

During its August 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended updating the product information of COVID-19 Vaccine Janssen.

Source: FAMHP

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Coronavirus: biweekly update of COVID-19 vaccines dated 29 July 2021

Coronavirus: tweewekelijks overzicht bijwerkingen COVID-19-vaccins van 29 juli 2021

Coronavirus : aperçu bimensuel des effets indésirables des vaccins contre la COVID-19 du 29 juillet 2021

Source: FAMHP

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Limited availability of RoActemra (Roche): recommendations for (hospital) pharmacists, general practitioners and physician specialists.

The stock of RoActemra, a medicinal product used for certain rheumatological and haematological disorders, is currently limited worldwide. The Federal Agency for Medicines and Health Products (FAMHP) therefore issues recommendations.

Source: FAMHP

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Give your opinion on a genetically modified medicine to treat dementia

The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified medicine PR006A to treat frontotemporal dementia with progranulin mutations (FTD-GRN).

Source: FAMHP

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Updated guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP

A new version of the guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP is available.

Source: FAMHP

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Safety notifications for medical devices from manufacturer Philips: CPAP, BiPAP and ventilation equipment

Veiligheidsmeldingen voor medische hulpmiddelen van fabrikant Philips: CPAP, BiPAP en beademingstoestellen

Informations de sécurité pour des dispositifs médicaux du fabricant Philips : CPAP, BiPAP et respirateurs

Source: FAMHP

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End of submissions for initial CTR pilot files on 14 October 2021

The pilot project for the new Clinical Trial Regulation (CTR) will end when the CTR Regulation enters into force. All initial dossiers under the CTR pilot procedure must be submitted by 14 October 2021.

Source: FAMHP

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Floods in Belgium: Continuity of access to medicines guaranteed in the affected areas

Overstromingen in België: continuïteit van de toegang tot geneesmiddelen gewaarborgd in de getroffen gebieden

Inondations en Belgique : la continuité de l’accès aux médicaments assurée dans les zones sinistrées

Source: FAMHP

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Unavailability of Visudyne 15 mg (powder for solution for infusion) : recommendations for (hospital) pharmacists and physicians-specialists

The medicinal product Visudyne 15 mg, used in ophthalmology, has been unavailable in Belgium since 30 May 2020. The FAMHP is therefore making recommendations.

Source: FAMHP

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Call for applications to participate in the IFAPP working groups

With the election of a new Board of Officers (BoO) with new Standing Officers as Chairs of the Working Groups (WGs) we encourage you to apply for active membership in on of the following WGs:

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Save the date: An EQ-5D-5L value set for Belgium – How to value health-related quality of life?

Source: KCE

Een Belgische waardenset voor de EQ-5D-5L – hoe gezondheidsgerelateerde levenskwaliteit waarderen?

Une matrice de valorisation belge pour l’EQ-5D-5L – Comment évaluer la qualité de vie liée à la santé ?

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Coronavirus: biweekly review of updates to COVID-19 vaccines from 15 July 2021

Source: FAMHP

Coronavirus: tweewekelijks overzicht bijwerkingen COVID-19-vaccins van 15 juli 2021

Coronavirus : aperçu bimensuel des effets indésirables des vaccins contre la COVID-19 du 15 juillet 2021

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First information session on the new Clinical Trial Regulation (CTR) on 23 September 2021

Source: FAMHP

The FAMHP is organising two information sessions on 23 September 2021 and 25 November 2021.

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Discontinuation of the telephone contact point of the Marketing Authorisation Division (variations and renewals)

Source: FAMHP

The telephone contact point of the Marketing Authorisation Division (variations and renewals) will be discontinued as of Friday 16 July 2021. The division can still be contacted by email.

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Coronavirus: take part in the scientific research on the coronavaccines because your experience makes vaccination even safer

Source: FAMHP

Coronavirus: neem deel aan het wetenschappelijk onderzoek over de coronavaccins want uw ervaring maakt vaccineren nog veiliger

Coronavirus : participez à l’étude scientifique sur les vaccins car votre expérience rend la vaccination encore plus sûre

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Update on ongoing evaluation of COVID-19 vaccines

Source FAMHP

Update on ongoing evaluation of COVID-19 vaccines, EMA advises on COVID-19 Vaccine Janssen and no evidence linking gene therapy Zynteglo to blood cancer

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Call for all sponsors to publish clinical trial results

Source FAMHP

The FAMHP reminds all sponsors they are obligated to publish the results of their clinical trials in the European Clinical Trials Database (EudraCT) within one year after the end of trial date (or six months for a paediatric trial).

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The use of contraception after treatment with genotoxic medicines: add recommendations to patient information leaflets

Source FAMHP

The FAMHP reminds marketing authorisation holders of the obligation to add recommendations on the use of contraception to the package leaflet of genotoxic medicines.

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3rd CRIG industrial partnering event

Source CRIG UGENT

Following the success of its first 2 editions (in 2017 and 2019), the Cancer Research Institute Ghent is pleased to announce the 3^rd CRIG industrial partnering event on Friday 22^nd October 2021.

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The FAMHP organises two information sessions on the new Clinical Trial Regulation (CTR)

Source FAMHP

FAMHP organises two information sessions, in collaboration with its stakeholders, for sponsors and applicants on 23 September 2021 and on 25 November 2021 on the new Clinical Trial Regulation (CTR).

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Limited availability of Bleomycine Sanofi 15,000 IU

Source FAMHP

The medicinal product Bleomycine Sanofi 15,000 IU, used in the treatment of certain cancers (testis, throat, mouth, Hodgkin's disease and non-Hodgkin's lymphoma), is currently in limited availability.

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International Horizon Scanning Initiative (IHSI): an international collaboration on innovative medicines and their impact

Source RIZIV

International Horizon Scanning Initiative (IHSI): een internationale samenwerking rond innovatieve geneesmiddelen en hun impact

International Horizon Scanning Initiative : Une collaboration internationale pour scruter l'horizon des médicaments innovants et leurs impacts

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Coronavirus: antigen self-tests can now also be sold outside pharmacies

Source: FAMHP

Coronavirus: antigen zelftesten kunnen voortaan ook buiten apotheek worden verkocht

Coronavirus : les autotests antigéniques peuvent désormais aussi être vendus ailleurs qu’en pharmacie

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Coronavirus: weekly overview of COVID-19 vaccine updates from 1 July 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 1 juli 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 1er juillet 2021

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Subcutaneous immunoglobulins: recommendations for (hospital) pharmacists and doctors (specialists) on reduced availability

Source: FAMHP

Subcutane immunoglobulinen: aanbevelingen voor (ziekenhuis)apothekers en artsen (specialisten) rond verminderde beschikbaarheid

Immunoglobulines sous-cutanées : recommandations liées à la réduction de la disponibilité pour les pharmaciens (d’hôpitaux) et les médecins (spécialistes)

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Coronavirus: COVID-19 weekly review of side effects 24 June 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 24 juni 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 24 juin 2021

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Coronavirus: details of the renewed measures taken by the FAMHP to avoid medicine shortages

Source: FAMHP

The FAMHP has once again renewed a number of measures in a new decision by the Chief Executive Officer of the FAMHP.

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Fight against antibiotic resistance in animals in Belgium

Source: FAMHP

Strijd tegen antibioticumresistentie bij dieren in België

Lutte contre l’antibiorésistance en médecine vétérinaire en Belgique

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New online form to report suspected side effects of animal treatments

Source: FAMHP

Nieuw online formulier om vermoedelijke bijwerkingen te melden van behandelingen bij dieren

Nouveau formulaire en ligne pour notifier les effets indésirables présumés de traitements chez l’animal

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Coronavirus: COVID-19 weekly review of side effects from 17 June 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 17 juni 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 17 juin 2021

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PRAC June 2021 – EMA advises on Vaxzevria (COVID-19 Vaccine AstraZeneca) and update on ongoing evaluation of COVID-19 vaccines

Source: FAMHP

During its June 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) advises against use of Vaxzevria in people with history of capillary leak syndrome.

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Webinar on antibiotic use and resistance in animals in Belgium: results 2020 and a look ahead to 2024

Source: FAMHP

Webinar over antibioticumgebruik en -resistentie bij dieren in België: resultaten 2020 en een blik vooruit naar 2024

Webinar sur l’utilisation des antibiotiques et antibiorésistance chez les animaux en Belgique: résultats 2020 et un coup d’œil sur 2024

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IFAPP Today newsletter

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of June 2021.

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Coronavirus: COVID-19 weekly review of side effects from 10 June 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 10 juni 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 10 juin 2021

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Coronavirus: EMA draws attention to treatment recommendations for suspected thrombocytopenia syndrome (TTS)

Source: FAMHP

Coronavirus: EMA vestigt de aandacht op aanbevelingen voor de behandeling bij vermoeden van het trombose trombocytopenie syndroom (TTS)

Coronavirus : l'EMA attire l'attention sur les recommandations de traitement en cas de suspicion de syndrome de thrombose-thrombocytopénie (TTS)

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Coronavirus: COVID-19 weekly review of side effects from 3 June 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 3 juni 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 3 juin 2021

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Coronavirus: EMA approves additional manufacturing capacity for Pfizer/BioNTech's COVID-19 vaccine

Source: FAMHP

Coronavirus: EMA keurt extra productiecapaciteit voor COVID-19-vaccin van Pfizer/BioNTech goed

Coronavirus : l'EMA approuve une capacité de production supplémentaire pour le vaccin COVID-19 de Pfizer/BioNTech

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PRAC May 2021 – Conclusions and reviews of safety signals related to COVID-19 vaccines

Source: FAMHP

During its May 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) reviewed a number of safety signals related to COVID-19 vaccines. 

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Coronavirus: COVID-19 weekly review of side effects from 27 May 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 27 mei 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 27 mai 2021

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VIG-news flash: Vaxzevria (AstraZeneca) and COVID-19 Vaccine Janssen

Source: FAMHP

Flash VIG-news: Vaxzevria (AstraZeneca) en COVID-19 Vaccine Janssen

Flash VIG-news : Vaxzevria (AstraZeneca) et COVID-19 Vaccine Janssen

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Medical devices: Regulation 2017/745 to apply from today

Source: FAMHP

Medische hulpmiddelen: Verordening 2017/745 vanaf vandaag van toepassing

Dispositifs médicaux : règlement 2017/745 applicable dès aujourd'hui

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Healixia webinar 'From EMA authorization to market access in Luxembourg'

You can find here our webinar 'From EMA authorization to market access in Luxembourg'

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Coronavirus: use of monoclonal antibody drug authorised

Source: FAMHP

Coronavirus: gebruik van geneesmiddel met monoklonale antilichamen toegestaan

Coronavirus : utilisation d'un médicament à anticorps monoclonaux autorisée

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Coronavirus: COVID-19 weekly review of side effects from 20 May 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 20 mei 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 20 mai 2021

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The FAMHP publishes its annual report for 2019

Source: FAMHP

As is customary and with full transparency, the FAMHP publishes the figures and results for 2019 for all its services and activities. 

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Coronavirus: COVID-19 weekly review of side effects from 12 May 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 12 mei 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 12 mai 2021

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Coronavirus: the FAMHP monitors stocks of medicines using a new tool

Source: FAMHP

Close monitoring of medicine stocks proved particularly useful during the COVID-19 pandemic. The FAMHP managed to act proactively and find solutions in time. The monitoring was done manually, but is now automated using a new Stock Monitoring Tool.

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Coronavirus: COVID-19 weekly review of side effects from 6 May 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 6 mei 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 6 mai 2021

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Flash VIG-news: rational prescribing of benzodiazepines and related drugs in sleep disorders

Source: FAMHP

Flash VIG-news: rationeel voorschrijven van benzodiazepines en aanverwante geneesmiddelen bij slaapstoornissen

Flash VIG-news : prescription rationnelle des benzodiazépines et apparentés dans le cadre des troubles du sommeil

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Coronavirus: deadline for submission of dossiers for sale of professional antigen tests as self-tests

Source: FAMHP

Coronavirus: deadline voor indienen dossiers voor verkoop van professionele antigeentests als zelftest

Coronavirus : date limite d’introduction des dossiers pour la vente des tests d’antigènes professionnels en tant qu'autotests

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Give your opinion on a genetically modified vaccine against the Rift Valley fever virus

Source: FAMHP

The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified vaccine hRVFV-4s against the Rift Valley fever virus. The public consultation will run from 30 April 2021 to 30 May 2021.

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Coronavirus: COVID-19 weekly review of side effects from 29 April 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 29 april 2021

Coronavirus: aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 29 avril 2021

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Coronavirus: weekly update of vaccine deliveries and information on vaccine materials from 27 April 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal van 27 april 2021

Coronavirus : mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination du 27 avril 2021

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Coronavirus: COVID-19 weekly review of side effects 22 April 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 22 april 2021

Coronavirus: aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 22 avril 2021

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PharmaStatus: new possibilities in online drug availability application

Source: FAMHP

FarmaStatus: nieuwe mogelijkheden in online applicatie over beschikbaarheid van geneesmiddelen

PharmaStatut : l’application en ligne offre de nouvelles fonctionnalités quant à la disponibilité des médicaments

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Coronavirus: weekly update of vaccine deliveries and information on vaccine materials from 20 April 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal van 20 april 2021

Coronavirus : mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination du 20 avril 2021

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Coronavirus: COVID-19 Vaccine Janssen: EMA finds possible link with very rare cases of unusual blood clots with low platelet counts. EMA confirms that benefit-risk balance remains positive

Source: FAMHP

Coronavirus: COVID-19 Vaccine Janssen: EMA vindt mogelijk verband met zeer zeldzame gevallen van ongewone bloedstolsels met laag aantal bloedplaatjes. EMA bevestigt dat de baten-risicoverhouding positief blijft

Coronavirus : COVID-19 Vaccine Janssen : L'EMA établit un lien possible avec de très rares cas de caillots sanguins inhabituels avec un faible taux de plaquettes. L'EMA confirme que la balance bénéfices-risques globale reste positive

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PRAC April 2021

Source: FAMHP

Conclusions and additional review on Vaxzevria (AstraZeneca’s COVID-19 vaccine), and new investigations on COVID-19 Vaccine Janssen

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Medical devices and active implantable medical devices (AIMD)

Source: FAMHP

New Medical Device Regulation

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Coronavirus: what you should know about rapid tests and self-tests

Source: FAMHP

Coronavirus: wat u moet weten over sneltesten en zelftesten

Coronavirus : ce que vous devez savoir sur les tests rapides et les autotests

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Coronavirus: COVID-19 weekly review of side effects from 15 April 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 15 april 2021

Coronavirus: aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 15 avril 2021

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Flash VIG news: Vaxzevria (AstraZeneca) - Publication of the DHPC

Source: FAMHP

Flash VIG-news: Vaxzevria (AstraZeneca) - publicatie van de DHPC

Flash VIG-news : Vaxzevria (AstraZeneca) - publication de la DHPC

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Coronavirus: weekly update of vaccine deliveries and information on vaccine materials from 13 April 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal van 13 april 2021

Coronavirus : mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination du 13 avril 2021

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IFAPP Today newsletter

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of April 2021.

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Coronavirus: COVID-19 weekly review of side effects from 8 April 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 8 april 2021

Coronavirus: aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 8 avril 2021

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Coronavirus: EMA sees possible link of Vaxzevria (AstraZeneca) with very rare cases of unusual low platelet clots

Source: FAMHP

Coronavirus: EMA ziet mogelijk verband van Vaxzevria (AstraZeneca) met zeer zeldzame gevallen van ongewone bloedstolsels met laag aantal bloedplaatjes

Coronavirus : l'EMA établit un lien possible entre Vaxzevria (AstraZeneca) et de très rares cas de caillots sanguins inhabituels associés à un faible taux de plaquettes sanguines

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 6 April 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus: mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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Reimbursement of medicines: what will change on 1 April 2021

Source: FAMHP

Terugbetaling van geneesmiddelen: wat wijzigt er op 1 april 2021

Remboursement de médicaments: quels sont les changements au 1^er avril 2021?

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Manufacturing and distribution authorisations and registrations of active pharmaceutical ingredients (API) distributed digitally

Source: FAMHP

Manufacturing authorisations and/or distribution authorisations of medicines and registrations of active pharmaceutical ingredients are no longer automatically sent in paper format by post to the marketing authorisation holder. 

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Coronavirus: COVID-19 weekly review of side effects from 1 April 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 1 april 2021

Coronavirus: aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 1 avril 2021

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 30 March 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus: mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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Coronavirus: self-tests soon available in pharmacies

Source: FAMHP

Coronavirus: zelftesten binnenkort verkrijgbaar via de apotheek

Coronavirus : les autotests bientôt disponibles en pharmacie

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Unavailability of drugs based on BCG (OncoTICE): update of the recommendations

Source: FAMHP

Onbeschikbaarheid van geneesmiddelen op basis van BCG (OncoTICE): update van de aanbevelingen

Indisponibilité des médicaments à base de BCG (OncoTICE): mise à jour des recommandations

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Coronavirus: COVID-19 weekly review of side effects from 25 March 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 25 maart 2021

Coronavirus: aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 25 maart 2021

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Flash VIG news: recommendations for thrombocytopenia and coagulation disorders with COVID-19 Vaccine AstraZeneca

Source: FAMHP

Flash VIG-news: aanbevelingen voor trombocytopenie en stollingsstoornissen bij COVID-19 Vaccine AstraZeneca

Flash VIG-news : recommandations sur la thrombocytopénie et les troubles de la coagulation pour le vaccin COVID-19 AstraZeneca

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PRAC March 2021 - Benefits of ifosfamide solutions continue to outweigh risks

Source: FAMHP

PRAC maart 2021 – Voordelen van ifosfamideoplossingen blijven opwegen tegen de risico's

PRAC mars 2021 – Les bénéfices des solutions d’ifosfamide restent supérieurs à leurs risques

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 23 March 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus: mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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Coronavirus: EMA holds third public hearing on new COVID-19 vaccines

Source: FAMHP

Coronavirus: het EMA organiseert een derde openbare hoorzitting over de nieuwe COVID-19 vaccins

Coronavirus : L'EMA organise une troisième audition publique sur les nouveaux vaccins COVID-19

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Coronavirus: COVID-19 weekly review of side effects from 18 March 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 18 maart 2021

Coronavirus: aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 18 maart 2021

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Coronavirus: benefits of COVID-19 Vaccine AstraZeneca still outweigh risks, despite possible link to extremely rare blood clots at low platelet counts

Source: FAMHP

Coronavirus: voordelen COVID-19 Vaccine AstraZeneca nog altijd groter dan de risico's, ondanks mogelijk verband met uiterst zeldzame bloedklonters bij lage hoeveelheid bloedplaatjes

Coronavirus : les avantages du COVID-19 Vaccine AstraZeneca l'emportent toujours sur les risques malgré un lien possible avec de rares formations de caillots sanguins associées à un taux bas de plaquettes sanguines

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Coronavirus: new update on research into thromboembolic events with AstraZeneca's COVID-19 vaccine

Source: FAMHP

Coronavirus: nieuwe update over onderzoek naar trombo-embolische voorvallen bij het COVID-19-vaccin van AstraZeneca

Coronavirus : nouvelle mise à jour de la recherche sur les événements thromboemboliques avec le vaccin contre la COVID-19 d'AstraZeneca

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Coronavirus: update on investigation of thromboembolic events with AstraZeneca's COVID-19 vaccine

Source: FAMHP

Coronavirus: update over onderzoek naar trombo-embolische voorvallen bij het COVID-19 vaccin van AstraZeneca

Coronavirus : mise à jour de l'enquête sur les incidents thromboemboliques avec le vaccin contre la COVID-19 d'AstraZeneca

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 16 March 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus: mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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Coronavirus: European Commission grants conditional marketing authorisation for Janssen's vaccine against COVID-19

Source: FAMHP

Coronavirus: Europese Commissie geeft voorwaardelijke marktvergunning voor het vaccin van Janssen tegen COVID-19

Coronavirus : la Commission européenne délivre une autorisation de mise sur le marché conditionnelle pour le vaccin de Janssen contre la COVID-19

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Coronavirus: EMA gives positive advice for Janssen vaccine

Source: FAMHP

Coronavirus: EMA geeft positief advies voor het vaccin van Janssen

Coronavirus : l’EMA émet un avis favorable pour le vaccin de Janssen

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IFAPP Today newsletter

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of March 2021.

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 9 March 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus: mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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Coronavirus: EMA starts rolling review of Sputnik V vaccine against COVID-19

Source: FAMHP

Coronavirus: EMA start doorlopende evaluatie (rolling review) van het Sputnik V-vaccin tegen COVID-19

Coronavirus : l'EMA lance une révision continue (« rolling review ») du vaccin Spoutnik V contre la COVID-19

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Coronavirus: COVID-19 weekly review of side effects from 4 March 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 4 maart 2021

Coronavirus: aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 4 maart 2021

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 2 March 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus: mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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Joint headquarters for the FPS Public Health, the NIHDI and the FAMHP

Source: FAMHP

Gemeenschappelijk hoofdkantoor voor de FOD Volksgezondheid, het RIZIV en het FAGG

Un siège central commun pour le SPF Santé publique, l’INAMI et l’AFMPS

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New covenant on antibiotic use in animals: ambitious goals set for the next four years

Source: FAMHP

Nieuw convenant over antibioticagebruik bij dieren: ambitieuze doelstellingen gedefinieerd voor de volgende vier jaar

Nouvelle convention sur l’usage des antibiotiques chez les animaux : des objectifs ambitieux définis pour les quatre prochaines années

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Coronavirus: COVID-19 weekly review of side effects from 25 February 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 25 februari 2021

Coronavirus: aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 25 février 2021

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Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

Source: FAMHP

On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have again been extended by one month.

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 23 February 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus: mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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Examination Statements or Certificate of Suitability for an Examining Institution (VGO)

News from the Netherlands

From 1 December 2020 to 1 June 2021, clients can choose whether to use the VGO or the current Research Statement for assessing the suitability of participating centres. Use of the VGO will be mandatory from 1 June 2021.

(article in Dutch)

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Royal Decree – Uploading files in 2021

News from beTransparent.be

From 2021 onwards, the uploading of a file will be subject to payment.

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The FAMHP calls for regularisation of stool banks as establishments of human body material

Source: FAMHP

The FAMHP invites establishments of human body material to apply for regularisation as stool banks. The term "stool" is no longer excluded from the scope of the law of 30 October 2018 on human body material. Establishments carrying out activities on faecal material as described in this law are subject to the implementing Royal Decrees and should apply for regularisation as stool bank.

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Coronavirus: COVID-19 weekly review of side effects from 18 February 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 18 februari 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 18 février 2021

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The intense cooperation between the RIZIV-INAMI, the FPS and the FAMHP is taking concrete shape in a single building with a common Health Service Centre

Source: RIZIV - INAMI

De intense samenwerking tussen het RIZIV, de FOD en het FAGG krijgt concreet vorm in één gebouw met één gemeenschappelijk Service Center Gezondheid

La collaboration intense entre l’INAMI, le SPF et l’AFMPS, concrétisée par une cohabitation et un Service Center Santé commun

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Coronavirus: Janssen applies to EMA for conditional marketing authorisation for vaccine

Source: FAMHP

Coronavirus: Janssen vraagt bij EMA voorwaardelijke marktvergunning voor vaccin aan

Coronavirus : Janssen demande à l’EMA une autorisation de mise sur le marché conditionnelle pour son vaccin

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 14 February 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus: mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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Survey on sleep disorder medicines reveals need for better medical monitoring

Source: FAMHP

Bevraging over geneesmiddelen tegen slaapstoornissen legt de noodzaak voor een betere medische opvolging bloot.

Une enquête sur les médicaments contre les troubles du sommeil révèle la nécessité d'un meilleur suivi médical.

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Coronavirus: EMA starts rolling review of CureVac vaccine against COVID-19

Source: FAMHP

EMA’s Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of the COVID 19 vaccine being developed by CureVac.

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Coronavirus: COVID-19 weekly review of side effects from 11 February 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 11 februari 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 11 février 2021

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Coronavirus: swabs: compliance verification

Source: FAMHP

Certain tests for COVID-19 use nasal swabs. Swabs are medical devices that must have a CE mark and meet certain requirements. The FAMHP recommends verifying the conformity of swabs.

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 9 February 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus: mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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IFAPP Today newsletter

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of February 2021.

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Coronavirus: COVID-19 weekly review of side effects from 4 February 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 4 februari 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 4 février 2021

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 26 January 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus: mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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Coronavirus: European Commission grants conditional marketing authorisation to AstraZeneca's vaccine against COVID-19

Source: FAMHP

Coronavirus: Europese Commissie geeft voorwaardelijke marktvergunning voor het vaccin van AstraZeneca tegen COVID-19

Coronavirus : la Commission européenne délivre une autorisation de mise sur le marché conditionnelle pour le vaccin d’AstraZeneca contre la COVID-19

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Coronavirus: EMA gives positive advice for AstraZeneca's vaccine

Source: FAMHP

Coronavirus: EMA geeft positief advies voor vaccin van AstraZeneca

Coronavirus : l’EMA émet un avis favorable pour le vaccin d’AstraZeneca

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Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

Source: FAMHP

On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have again been extended by one month.

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IFAPP Today newsletter

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of January 2021.

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APL webinar on 18 February - LUXEMBOURG MEDICINAL PRODUCTS LAW

Source: APL

Camille Saettle from Tewes & Reuter presents her new book on the law of medicinal products in Luxembourg

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Coronavirus: COVID-19 weekly review of side effects from 28 January 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 28 januari 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 28 janvier 2021

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 26 January 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus: mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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CTIS Master Trainers Training Programme for sponsors

Source: FAMHP

Future training CTR

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Coronavirus: weekly update of vaccine deliveries and information on vaccination materials - 19 January 2021

Source: FAMHP

Coronavirus: wekelijkse update van leveringen van vaccins en informatie over vaccinatiemateriaal

Coronavirus : mise à jour hebdomadaire des livraisons de vaccins et informations sur le matériel de vaccination

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Coronavirus: COVID-19 weekly review of side effects from 21 January 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 21 januari 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 21 janvier 2021

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Update on the Mdeon procedure

Source: Mdeon

Some important updates on the Mdeon procedures.

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The federal healthcare administrations are looking for new talent

Source: RIZIV - INAMI

50 scientific masters for the Federal Health Administrations (m/f/x) - Apply by 28 January 2021 (in Dutch)

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Coronavirus: COVID-19 weekly review of side effects from 14 January 2021

Source: FAMHP

Coronavirus: wekelijks overzicht bijwerkingen COVID-19-vaccins van 14 januari 2021

Coronavirus : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19 du 14 janvier 2021

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Influenza vaccine: vaccination of most vulnerable groups completed, influenza vaccine can be delivered to people in the non-risk groups

Source: FAMHP

Griepvaccin: vaccinatie meest kwetsbare groepen voltooid, griepvaccin kan worden afgeleverd aan personen uit de niet-risicogroepen

Vaccin contre la grippe : la vaccination des groupes les plus vulnérables est terminée, le vaccin contre la grippe peut être administré aux personnes appartenant à des groupes sans risque

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Instruction video about Covid-19 for health care providers

The Covid Vaccination Task Force, together with OptiHealth, developed the following instructional video for healthcare providers.

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IFAPP presents: free webinar on 'COVID-19 PANDEMIC IN JAPAN: FACTS AND EXPECTATIONS'

Source: IFAPP

On 25 February 2021

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Amended legislation: drug precursors added to list of scheduled substances

Source: FAMHP

The new European Commission Regulation (EU) 2020/1737 adds certain drug precursors to the list of scheduled substances. In addition, certain Combined Nomenclature (CN) codes for drug precursors were amended. The regulation enters into force in stages: the first stage started on 13 December 2020 and the second stage on 13 January 2021.

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Flash VIG-News: Metamizole (NOVALGINE): information on risk of liver injury and pharmacokinetic interactions

Source: FAMHP

Flash VIG-news: Metamizol (NOVALGINE): informatie over het risico van leverletsel en farmacokinetische interacties

Flash VIG-news : Métamizole (NOVALGINE) : informations sur les risques de troubles hépatiques et d’interactions pharmacocinétiques

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Coronavirus: EMA receives application for conditional marketing authorisation for AstraZeneca vaccine

Source: FAMHP

Coronavirus: EMA ontvangt aanvraag voor een voorwaardelijke marktvergunning voor vaccin AstraZeneca

Coronavirus : l'EMA reçoit une demande d'autorisation de mise sur le marché conditionnelle pour le vaccin d’AstraZeneca

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Flash VIG-news: weekly overview of side effects COVID-19 vaccines

Source: FAMHP

Flash VIG-news: wekelijks overzicht bijwerkingen COVID-19-vaccins

Flash VIG-news : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19

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Coronavirus: sixth dose from vials of Comirnaty vaccine (Pfizer/BioNTech)

Source: FAMHP

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended updating the product information for Comirnaty to clarify that each vial contains six doses of the vaccine.

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Flash VIG-news: weekly overview of side effects COVID-19 vaccines

Flash VIG-news: wekelijks overzicht bijwerkingen COVID-19-vaccins

Flash VIG-news : aperçu hebdomadaire des effets indésirables des vaccins contre la COVID-19

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Corona virus: EMA gives positive opinion for Moderna vaccine

Source: FAMHP

Coronavirus: EMA geeft positief advies voor vaccin van Moderna

Coronavirus : l’EMA émet un avis favorable pour le vaccin de Moderna

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Coronavirus: EMA organises a second public meeting about the new COVID-19 vaccines

Source: FAMHP

The European Medicines Agency (EMA) will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines.

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Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

Source: FAMHP

On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have again been extended by one month.

Read more

Coronavirus: Questions and Answers on COVID-19 vaccines

Source: FAMHP

Coronavirus: vragen en antwoorden over de COVID-19-vaccins

Coronavirus : questions et réponses sur les vaccins contre la COVID-19

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Coronavirus: new online form to report suspected adverse reactions to a COVID-19 vaccine

Source: FAMHP

A new online form now makes it easier to report suspected adverse reactions to a COVID-19 vaccine. The new user-friendly form will also be linked to Vaccinnet+. Therefore, certain fields will be filled in automatically in the future. Reporting adverse reactions can increase the knowledge of the safety profile of the vaccines. The FAMHP will regularly provide an update on the follow-up of the reports.

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Coronavirus: end of derogations for surgical mouth masks

Source: FAMHP

Coronavirus: einde van de uitzonderingsmaatregelen voor chirurgische mondmaskers

Coronavirus : fin des mesures exceptionnelles pour les masques buccaux chirurgicaux

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Coronavirus: the EMA gives a first positive opinion for COVID-19 vaccine

Source: FAMHP

The European Medicines Agency (EMA) issued a positive opinion for Comirnaty, the Pfizer/BioNTech vaccine, making it the first COVID-19 vaccine that could be authorised for marketing in the European Union. 

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Coronavirus: European Commission gives conditional market authorisation for vaccine against COVID-19

Source: FAMHP

The European Commission granted a conditional marketing authorisation for Comirnaty, the Pfizer/BioNTech vaccine. The Commission is following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). 

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Save the date: APL webinar on 18 February 2021

Source: APL

Camille Saettel, Attorney at Law, Partner, will present her very recent book which deals with the law of medicines in Luxembourg. 

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Marevan (warfarin): packages containing 60 tablets may be placed back on the market

Source: FAMHP

On 20 November 2020, the FAMHP recalled Marevan 60 tablets of 5 mg (manufactured by Therabel) at pharmacy level. The quality of the medicinal product can now be guaranteed, meaning that the recalled batches may be placed back on the market. As soon as its price is approved (by the FPS Economy), the medicinal product may be supplied to pharmacies.

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Update on the guidance document to assist clinical trials sponsors as part of the pilot project of the FAMHP

Source: FAMHP

Based on the evolution of the pilot project for the new Clinical Trial Regulation, the FAMHP made an update on the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials.

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Critical antibiotics in veterinary medicine: sampling is mandatory again

Source: FAMHP

The FAMHP announces the reintroduction of certain articles in the Royal Decree of 21 July 2016. Sampling is once again mandatory before using critical antibiotics in veterinary medicine. This measure applies to all veterinarians and people responsible for animals.

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End of year message by Healixia President Erik Present

The first 'Healixia year' has come to an end. A special year, but also a successful year. We are ready for 2021!

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Risk Minimisation Activities (RMA): clarifications for authorisation holders on Circular No. 635

Source: FAMHP

Circular No. 635 of 4 May 2018 details the approval procedure for risk minimisation activities (RMA). Certain paragraphs of this circular could be misinterpreted and specific situations were not considered. Therefore, the FAMHP would like to provide details on the RMA material included in the medicine package and on the addition / modification of RMA material  for a medicine that is already available on the market.

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News from Luxembourg

Semper Luxembourg - November 2020

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Corona virus: questions and anwers about the COVID-19 vaccine

Source: FAMHP

Coronavirus: vragen en antwoorden over de COVID-19-vaccins

Coronavirus: questions et réponses sur les vaccins contre la COVID-19

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Medication errors: 112 errors reported to the FAMHP since 2016

Source: FAMHP

The FAMHP Medication errors working group has received 112 notifications of proven or potential errors since 2016. Thanks to these notifications, corrective or preventive measures were put in place, in collaboration with the pharmaceutical industry.

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IFAPP Today newsletter

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of December 2020.

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Influenza vaccination: extension of priority for most vulnerable persons

Source: FAMHP

Griepvaccinatie: verlenging van prioriteit voor meest kwetsbare personen

Vaccination contre la grippe: prolongation de la priorité pour les personnes les plus vulnérables

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Corona virus: the Interministerial Conference on Public Health signs the European purchase of the Moderna candidate vaccine and finalises COVID-19 vaccination strategy.

Coronavirus: de Interministeriële Conferentie Volksgezondheid tekent in op de Europese aankoop van het kandidaatvaccin Moderna en legt laatste hand aan COVID-19 vaccinatiestrategie

Coronavirus : La Conférence Interministérielle Santé publique souscrit à la procédure d’achat européenne pour le candidat vaccin Moderna et finalise la stratégie de vaccination COVID-19

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Coronavirus: EMA receives first two applications for conditional marketing authorisation for COVID-19 vaccines

Source: FAMHP

Coronavirus: EMA ontvangt de eerste twee aanvragen voor een voorwaardelijke marktvergunning voor COVID-19-vaccins

Coronavirus: l'EMA reçoit les deux premières demandes d'autorisation de mise sur le marché conditionnelle pour des vaccins contre la COVID-19

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Oral nicotine pouches are considered medicinal products

Source: FAMHP

Considering the risk to the consumer, the Joint Commission’s Chamber for products for human use has deemed that “Killapods” or “Lyft”-style oral nicotine pouches are to be considered medicinal products by function.

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Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

Source: FAMHP

On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have now been extended by one month.

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Flash VIG-news: Trisenox (arsenic trioxide): risk of medication errors due to the introduction of a new concentration of 2 mg/ml

Source: FAMHP

The FAMHP warns healthcare professionals prescribing, delivering and administering Trisenox about the risk of dosing errors as a new presentation of the medicine is launched on the market.

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Brexit: the FAMHP reminds marketing authorisation holders at the end of the transitional period to submit variations

Source: FAMHP

- Brexit: het FAGG herinnert houders van een vergunning voor het in de handel brengen aan het einde van de overgangsperiode om variaties in te dienen

- Brexit: l’AFMPS rappelle aux titulaires d’autorisation de mise sur le marché la fin de la période de transition pour soumettre les variations

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Coronavirus: Belgium subscribes to the purchase of the CureVac candidate vaccine

Source: FAMHP

- Coronavirus: België tekent in op de aankoop van kandidaatvaccin CureVac

- Coronavirus: La Belgique souscrit à l’achat du vaccin candidat CureVac

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Marevan (warfarin): recall and recommendations to prescribers, pharmacists and patients

Source: FAMHP

- Marevan (warfarine): terugroeping en aanbevelingen aan voorschrijvers, apothekers en patiënten

- Marevan (warfarine): rappel et recommandations aux prescripteurs, aux pharmaciens et aux patients

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New directive on rational prescription of antibiotics by dentists

Source: FAMHP

Nieuwe richtlijn voor rationeel voorschrijven van antibiotica door tandartsen

Nouveau guide clinique pour la prescription prudente d’antibiotiques en pratique dentaire

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Coronavirus: Belgium subscribes to the purchase of candidate vaccines Pfizer and BioNTech

Source: FAMHP

Coronavirus: België tekent in op de aankoop van kandidaatvaccin Pfizer en BioNTech

Coronavirus : La Belgique souscrit à l’achat du vaccin candidat Pfizer et BioNTech

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International week to raise awareness of the prudent use of antibiotics: favourable developments in veterinary medicine, but special attention for the poultry sector

Source: FAMHP

Internationale week van de sensibilisering voor verstandig gebruik van antibiotica: gunstige evoluties in de diergeneeskunde, maar bijzondere aandacht voor de pluimveesector

Semaine mondiale de sensibilisation pour un usage prudent des antibiotiques : du progrès en médecine vétérinaire mais une attention particulière pour le secteur de la volaille

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Give your opinion on a genetically modified medicinal product for the treatment of haemophilia A

Source: FAMHP

Geef uw mening over een genetisch gewijzigd geneesmiddel voor de behandeling van hemofilie A

Donnez votre avis sur un médicament génétiquement modifié pour le traitement de l’hémophilie A

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Electronic submission of application art. 111 / 112 / 113

Source: RIZIV - INAMI

Procedure aanvraag overeenkomst 'Art 111/112/113'

Procédure demande convention 'Art 111/112/113'

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New procedures for exchanging information, sending documents and applying electronically for the conclusion of a contract.

Source: RIZIV - INAMI

Nieuwe procedures voor de uitwisseling van informatie, versturen van documenten en voor het elektronisch indienen van een aanvraag tot het afsluiten van een overeenkomst.

Nouvelles procédures pour l'échange d'informations, la transmission de documents et pour la soumission électronique d'une demande de conclusion de convention.

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Give your opinion on a genetically modified drug for the treatment of certain lung and skin cancers

Source: FAMHP

The FPS Public Health and the FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified drug Nous-PEV (formed by the experimental drugs GAd-PEV and MVA-PEV) for the treatment of certain lung and skin cancers. The public consultation will run from 10 November 2020 to 10 December 2020.

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Coronavirus: the FAMHP again calls for rational use of oxygen

Source: FAMHP

- Coronavirus: het FAGG roept opnieuw op tot rationeel gebruik van zuurstof

- Coronavirus: l'AFMPS plaide à nouveau pour une utilisation rationnelle de l'oxygène

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IFAPP Today newsletter

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of November 2020.

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Influenza vaccine: absolute priority for protection of most vulnerable people

Source: FAMHP

Griepvaccin: absolute prioriteit voor bescherming meest kwetsbare mensen

Vaccination contre la grippe: priorité absolue pour protéger les personnes les plus vulnérables

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Submission of dossiers during end-of-year period: final date is 15 December, except for COVID-19 dossiers

Source: FAMHP

During the end-of-year period the FAMHP will be closed from Friday 25 December 2020 up to and including Sunday 3 January 2021. Deadlines have been set for the submission of different types of files.

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Flash VIG-news: ESMYA® (ulipristal acetate 5 mg): revocation of the marketing authorisation

Source: FAMHP

After reviewing the benefit-risk ratio of the medicinal product ESMYA®, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the definitive revocation of its marketing authorisation (MA).

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Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

Source: FAMHP

On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have now been extended by one month.

Read more

New ESVAC report: antibiotic use continues to decline in animal husbandry in Europe.

Source: FAMHP

The European Medicines Agency (EMA) published the tenth ESVAC report (European Surveillance of Veterinary Antimicrobial Consumption) about the sale of antibacterial agents for veterinary use in 2018. Further efforts remain necessary, in Belgium as well.

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Influenza vaccines: the FAMHP conducts a survey of all pharmacies.

Source: FAMHP

Griepvaccins: het FAGG doet een bevraging bij alle apotheken

Vaccins contre la grippe: l'AFMPS mène une enquête auprès de toutes les pharmacies

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Coronavirus: Belgium agrees on procurement of Janssen's (Johnson & Johnson) vaccine candidate

Source: FAMHP

The European Commission is holding negotiations on behalf of the Member States for procurement procedures for COVID-19 vaccines and is presenting contracts to the Member States. In Belgium, the Advisory Committee responsible for the analysis of the procurement files issued a positive recommendation for Janssen's (Johnson & Johnson) vaccine candidate. The Interministerial Conference (IMC) for Public Health has followed the advice. Belgium will buy the vaccine when the it is authorised.

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Influenza vaccine: another million doses are on the way and will be distributed to pharmacies at the end of October, beginning of November.

Source: FAMHP

Griepvaccin: nog een miljoen dosissen zijn op komst en zullen eind oktober, begin november worden verdeeld naar de apotheken

Vaccin contre la grippe : un million de doses sont encore prévues et seront distribuées dans les pharmacies fin octobre, début novembre

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Limited availability of the Pneumovax 23® vaccine: recommendations for prescribers, (hospital) pharmacists and wholesalers

Source: FAMHP

Beperkte beschikbaarheid van het vaccin Pneumovax 23®: aanbevelingen aan voorschrijvers, (ziekenhuis)apothekers en groothandelaars

Disponibilité limitée du vaccin Pneumovax 23® : recommandations aux prescripteurs, aux pharmaciens (hospitaliers) et aux grossistes

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Influenza vaccine: 10% already delivered to the patient, two-thirds still to be delivered to the (hospital) pharmacies.

Source: FAMHP

Griepvaccin: al 10 % afgeleverd aan de patiënt, twee derden moet nog aan de (ziekenhuis)apotheken worden geleverd

Vaccin contre la grippe : déjà 10 % des stocks livrés au patient, les deux tiers restent à livrer aux pharmacies (hospitalières)

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IFAPP Today newsletter

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of October 2020.

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Central traceability register: the traceability of certain implants to become compulsory

Source: FAMHP

From 1 May 2021, notification of the insertion or removal of implants will become compulsory for the implants listed in the annex to the Royal Decree of 27.09.2020 relating to the Central Traceability Register (RCT in French). This notification was already possible (but not compulsory) for all implants since 2014.

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Coronavirus: EMA starts first rolling reviews of COVID-19 vaccines

Source: FAMHP

EMA’s human medicines committee (CHMP), in which the FAMHP takes part, has started the first ‘rolling reviews’ of COVID-19 vaccines. The review concerns the vaccine developed by AstraZeneca and the University of Oxford and the vaccine developed by BioNTech and Pfizer. 

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Coronavirus – a new validation procedure for serological tests

Source: FAMHP

In April 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) and Sciensano set up an extraordinary validation procedure for serological tests for SARS-CoV-2. The procedure turned out to be effective during the initial phase of the pandemic. The situation being experienced by the manufacturers and distributors of these tests and by the clinical laboratories carrying out the tests has now returned to normal. This is why a staged return to the conventional way of working is now being implemented.

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Influenza vaccine: people over 50 can obtain vaccine from a pharmacy without a prior prescription.

Source: FAMHP

Griepvaccin: 50-plussers kunnen zonder voorafgaand voorschrift vaccin halen bij de apotheek

Vaccin contre la grippe : les personnes de 50 ans et plus peuvent se faire délivrer le vaccin sans prescription préalable en pharmacie

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TOPRA Symposium 2020 - The evolving world of Regulatory Affairs: innovate regulation or regulate innovation?

Source: FAMHP

How can health authorities such as the Federal Agency for Medicines and Health Products (FAMHP) and the European Medicines Agency (EMA), in collaboration with all stakeholders, regulate innovative medicines and health products and innovate regulations? Find out all about it at the 17th TOPRA symposium, where innovation is central and which will take place from 5 to 8 October 2020. This symposium is organized in collaboration with the FAMHP.

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Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

Source: FAMHP

On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have now been extended by one month.

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Give your opinion on a genetically modified drug for the treatment of Duchenne muscular dystrophy

Source: FAMHP

The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified drug PF-06939926 for the treatment of Duchenne muscular dystrophy. The public consultation will run from 23 September 2020 to 23 October 2020.

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Coronavirus: at-home antibody tests are no longer banned, but the FAMHP warns against misinterpreting the result

Source: FAMHP

The sale of at-home tests detecting antibodies against the new coronavirus (SARS-CoV-2) will no longer be prohibited as of 19 September 2020. However, the FAMHP warns users that there are still significant reservations about the accuracy of both negative and positive results. These at-home tests may give users a false sense of security or cause them unnecessary anxiety.

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New edition VIG-news available

Source: FAMHP

Nieuwe editie VIG-news beschikbaar.

Nouvelle édition VIG-news disponible. 

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PRAC September 2020 – Revocation of marketing authorisation of ulipristal acetate (Esmya) for uterine fibroids

Source: FAMHP

During its meeting of September 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended the revocation of marketing authorisation of ulipristal acetate for uterine fibroids.

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Gardasil, vaccine against HPV (Human Papillomaviruses), is available again

Source: FAMHP

After a period of limited availability, the Gardasil 9 vaccine, used to prevent Human Papillomaviruses (HPV), is available to everyone again.

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Coronavirus - Consultation between the FAMHP and the clinical laboratories on serological tests COVID-19

Source: FAMHP

Coronavirus - Overleg tussen het FAGG en de klinische labo's over de serologische tests COVID-19

Coronavirus – Concertation entre l’AFMPS et les laboratoires cliniques quant aux tests sérologiques COVID-19

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Healixia traject - Let's connect

Whenever and wherever

We have worked out a traject of multiple online events. 

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Nitrosamines in medicinal products: deadlines for submitting risk assessments, the results of confirmatory tests and the MA adaptation

Source: FAMHP

Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked all marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution.

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Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

Source: FAMHP

On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have now been extended by one month.

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In Memoriam, Stefaan Vancayzeele

Thursday August 27th, Stefaan Vancayzeele has passed away.

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Influenza vaccination 2020-2021: sequential approach with priority for at-risk groups

Source: FAMHP

COVID-19 makes it important to be able to vaccinate at-risk groups to the maximum extent possible in order to avoid overburdening the healthcare sector. Therefore, influenza vaccination for 2020-2021 will be phased in, giving priority to those at risk.

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Coronavirus - Belgium joins Europe for the purchase of the vaccine candidate against COVID-19 from AstraZeneca

Source: FAMHP

Coronavirus – België doet mee met Europa voor de aankoop van het kandidaatvaccin tegen COVID-19 van AstraZeneca

Coronavirus - La Belgique rejoint l'Europe pour l'achat du candidat vaccin contre le COVID-19 d'AstraZeneca

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Corona virus - Advisory Committee on choice COVID-19 vaccines deals with first file

Source: FAMHP

Coronavirus - Adviescomité voor keuze COVID-19 vaccins behandelt eerste dossier

Coronavirus - Le comité consultatif pour le choix des vaccins contre le COVID-19 traite son premier dossier

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Serological COVID-19 tests purchased by the government are reliable

Source: FAMHP

Serologische COVID-19-testen aangekocht door de overheid zijn betrouwbaar

Les tests sérologiques COVID-19 achetés par le gouvernement sont fiables

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Pilot project "e-PIL": paper leaflet makes way for electronic leaflet

Source: FAMHP

Proefproject “e-PIL”: papieren bijsluiter maakt plaats voor elektronische bijsluiter

Projet pilote « e-PIL » : la notice papier fait place à la notice électronique

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Coronavirus – Evaluation of the use of saliva samples as an alternative to sampling via a deep nasal swab to detect SARS-CoV-2, the virus that causes COVID-19

Source: FAMHP

Because of the benefits to both patients and healthcare professionals, a study on the use of saliva samples as an alternative to sampling via a deep nasal swab (nasopharyngeal) to detect SARS-CoV-2 using molecular detection tests (PCR) was launched on 28 May 2020.

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Coronavirus - Derogation for COVID-19 clinical trials of medicinal products containing or consisting of genetically modified organisms

Source: FAMHP

In the context of the COVID-19 crisis, the European Union adopted a regulation providing for a temporary derogation from European legislation on genetically modified organisms.

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Give your opinion on a genetically modified drug for advanced or metastatic solid tumours

Source: FAMHP

Donnez votre avis sur un médicament génétiquement modifié contre les tumeurs solides avancées ou métastatiques

Geef uw mening over een genetisch gewijzigd geneesmiddel tegen gevorderde of gemetastaseerde solide tumoren

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Is the electronic package leaflet as effective as the paper version? Evaluation of the "e-PIL" pilot project

Source: FAMHP

Is de elektronische bijsluiter even doeltreffend als de papieren versie? Evaluatie van het pilootproject “e-PIL”

La notice électronique est-elle aussi efficace que la version papier ? Évaluation du projet pilote e-PIL

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Coronavirus: shortened deadlines for clinical trials

Source: FAMHP

Coronavirus: verkorte termijnen voor klinische proeven

Coronavirus : délais raccourcis pour les essais cliniques

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Identity theft: attempts to order medical equipment on behalf of the FAMHP

Source: FAMHP

Identiteitsdiefstal: pogingen om in naam van het FAGG medisch materiaal te bestellen

Usurpation d'identité : tentatives de commande de matériel médical pour le compte de l'AFMPS

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Reaction of the FAMHP to information in the media on serological tests

Source: FAMHP

Reactie van het FAGG op de informatie in de media over serologische testen

Réaction de l'AFMPS aux informations des médias sur les tests sérologiques

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Nitrosamines in medicinal products: templates and web forms for submitting the results of confirmatory tests

Source: FAMHP

Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked all marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The result of this risk assessments (step 1) must be reported via the particular web form before 1 October 2020. Another particular web form is available for submitting the results of the confirmatory tests (step 2).

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Flash VIG-news: avoid dosing errors with liquid drug forms for oral use by using the included dosing aid

Source: FAMHP

Flash VIG-news: vermijd doseringsfouten met vloeibare geneesmiddelvormen voor oraal gebruik door het bijgeleverde doseerhulpmiddel te gebruiken

Flash VIG-news : évitez les erreurs de dosage des formes liquides orales en utilisant le dispositif doseur livré avec le médicament

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Coronavirus and the battle by the FAMHP: FAMHP is preparing for a possible resurgence of the pandemic

Source: FAMHP

Coronavirus en de strijd gevoerd door het FAGG: FAGG bereidt zich voor op mogelijke heropflakkering pandemie 

Coronavirus et la lutte menée par l’AFMPS : l’AFMPS se prépare pour un rebond potentiel de la pandémie

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Coronavirus: new extension of measures taken by the FAMHP to avoid shortages of medicines

Source: FAMHP

Coronavirus: nieuwe verlenging van maatregelen die het FAGG heeft genomen om tekorten aan geneesmiddelen te vermijden

Coronavirus : nouvelle extension des mesures prises par l'AFMPS pour éviter la pénurie de médicaments

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The FAMHP carries out hundreds of checks and inspections to guarantee the conformity and safety of medicines and health products.

Source: FAMHP

FAGG voert honderden controles en inspecties uit om de conformiteit en veiligheid van geneesmiddelen en gezondheidsproducten te garanderen.

l’AFMPS effectue des centaines de contrôles et inspections pour garantir la conformité et la sécurité des médicaments et produits de santé

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Coronavirus and the battle by the FAMHP: FAMHP continuously monitors the safety of treatments

Source: FAMHP

Coronavirus en de strijd gevoerd door het FAGG: FAGG waakt continu over de veiligheid van behandelingen

Coronavirus et la lutte menée par l’AFMPS : l’AFMPS veille en permanence à la sécurité des traitements

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Coronavirus: the FAMHP adds dexamethasone to the list of medicines subject to controlled distribution measures.

Source: FAMHP

Coronavirus: het FAGG voegt dexamethason toe aan de lijst van geneesmiddelen die onderworpen zijn aan gecontroleerde distributiemaatregelen.

Coronavirus : l’AFMPS ajoute la dexaméthasone à la liste des médicaments soumis aux mesures de distribution contrôlée

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Coronavirus and the battle by the FAMHP: FAMHP solutions for shortages of medical equipment

Source: FAMHP

Coronavirus en de strijd gevoerd door het FAGG: oplossingen van het FAGG voor tekorten aan medisch materiaal

Coronavirus et la lutte menée par l’AFMPS : les solutions mises en place par l’AFMPS face au manque de matériel médical

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Limited availability of the vaccine Gardasil 9: update of recommendations to prescribers

Source: FAMHP

Beperkte beschikbaarheid van het vaccin Gardasil 9: update van de aanbevelingen aan voorschrijvers

Disponibilité limitée du vaccin Gardasil 9 : mise à jour des recommandations pour les prescripteurs

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Coronavirus and the battle of the FAMHP: FAMHP facilitates and supports development of treatments and vaccines for COVID-19.

Source: FAMHP

Coronavirus en de strijd gevoerd door het FAGG: FAGG faciliteert en steunt ontwikkeling van behandelingen en vaccins voor COVID-19

Coronavirus et la lutte menée par l’AFMPS : l’AFMPS facilite et soutient le développement des traitements et vaccins COVID-19

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Decreasing trend in the use of antibiotics in Belgian livestock farming continues

Source: FAMHP

Dalende trend van het antibioticagebruik in de Belgische veeteelt zet zich verder.

Nouvelle tendance à la baisse de la consommation d’antibiotiques dans l’élevage en Belgique

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Coronavirus and the battle of the FAMHP: thorough work so that every patient can be treated

Source: FAMHP

Sinds het begin van de coronapandemie werken de teams van het FAGG keihard om de ziekenhuizen en apotheken te ondersteunen bij hun problemen met de bevoorrading van geneesmiddelen. Hieronder volgt een overzicht van de maatregelen die het FAGG heeft genomen om de geneesmiddelenvoorraad in België te garanderen. 

Depuis le début de la pandémie de coronavirus, les équipes de l’AFMPS travaillent à un rythme intense pour soutenir les hôpitaux et les pharmacies face aux difficultés d’approvisionnement en médicaments. Voici un aperçu des mesures mises en place par l’AFMPS pour garantir les stocks de médicaments en Belgique.

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Coronavirus : first COVID-19 vaccine trial authorized in Belgium

Source: FAMHP

The Federal Agency for Medicines and Health Products (FAMHP) has authorized the first clinical trial evaluating a vaccine against COVID-19 in Belgium. This is the candidate vaccine from the German biotech firm CureVac.

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Reaction of the FAMHP to information in the media on serological tests

Source: FAMHP

Reactie van Xavier De Cuyper, administrateur-generaal van het FAGG.

Réaction de Xavier De Cuyper, administrateur général de l’AFMPS.

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Coronavirus: the FAMHP is allowing an extension of the payment deadlines expiring before 01.07.2020.

Source: FAMHP

In the context of the coronavirus crisis, the FAMHP is extending all payment periods expiring before 01.07.2020 for all its customers.

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EMA warns against use of unproven cell therapies

Heard from FAMHP

The Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) advises patients and citizens not to use unregulated cell therapies, which may be unsafe or ineffective.

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Coronavirus: reminder of the risks of chloroquine and hydroxychloroquine

Heard from FAMHP

The FAMHP restates the risks linked to the use of chloroquine and hydroxychloroquine to treat COVID-19 following the publication of a retrospective analysis of a patient monitoring register in the medical journal The Lancet on 22 May 2020. The analysis did not highlight any benefits from these drugs in patients with COVID-19 and revealed adverse cardiovascular effects.

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Coronavirus: updated guidelines for verifying the compliance and suitability of surgical face masks

Heard from FAMHP

The FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks during the COVID-19 crisis. The guidelines are intended for companies, institutions and authorities that order, sell or use these masks.

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Coronavirus: recommendations for replacing closed suction systems

Heard from FAMHP

The FAMHP reminds hospitals of the recommendations for replacing closed suction systems and offers temporary practical advice to help healthcare professionals waiting on a new stock of suction systems.

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Coronavirus: relaxation of paracetamol measures for pharmacists and patients

Heard from FAMHP

Sales of paracetamol remain stable, which is why the restriction of only one box per patient is being lifted. The quotas for pharmaceutical companies and wholesalers have already been abolished. Only the intravenous form remains subject to restriction.

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The FAMHP web portal - updates to the “My company” and “My activities” applications

Heard from FAMHP

In anticipation of the European regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), the FAMHP has updated the “My company” and “My activities” applications in its web portal.

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Coronavirus: extension and relaxation of measures taken by the FAMHP to prevent shortages of medicines

Heard from FAMHP

Coronavirus: verlenging en versoepeling van maatregelen die het FAGG heeft genomen om tekorten aan geneesmiddelen te vermijden

Coronavirus : extension et assouplissement des mesures prises par l'AFMPS pour éviter la pénurie de médicaments

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Coronavirus: update of guidelines to check the conformity and suitability of surgical mouth masks

Heard from FAMHP

Coronavirus: update van de richtlijnen om de conformiteit en geschiktheid van chirurgische mondmaskers na te gaan

Coronavirus : mise à jour des lignes directrices pour vérifier la conformité et l’aptitude des masques buccaux chirurgicaux

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Pharmaboardroom.com had a talk with Healixia President Erik Present

PharmaBoardroom, a leading website for C-Level executives working in Healthcare and Life Sciences interviewed Healixia President Erik Present.

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Coronavirus: national guideline for the management of clinical investigation for medical devices during the coronavirus pandemic

Heard from FAMHP

Coronavirus: nationale richtlijn voor het beheer van klinische onderzoek voor medische hulpmiddelen tijdens de coronaviruspandemie

Coronavirus : ligne directrice nationale pour la gestion d’investigations cliniques sur les dispositifs médicaux durant la pandémie de coronavirus

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Coronavirus: European Medicines Agency advises continued use of medicines to treat high blood pressure, heart and kidney disease

Heard from FAMHP

Coronavirus: Europees Geneesmiddelenbureau adviseert om geneesmiddelen tegen hoge bloeddruk, hart- en nieraandoeningen te blijven gebruiken

Coronavirus : l’Agence européenne des médicaments recommande de continuer à utiliser les médicaments contre l’hypertension, les maladies cardiaques ou rénales

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Coronavirus: good practice for changing consumables of ventilation equipment in COVID-19 patients

Heard from FAMHP

Coronavirus: goede praktijken voor het veranderen van verbruiksgoederen van beademingstoestellen bij COVID-19 patiënten

Coronavirus : bonnes pratiques dans le changement des consommables liés au respirateurs des patients COVID -19

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The impact of COVID 19 on the FAMHP

On 29 April 2020, we organised a webinar 'the impact of COVID 19 on the FAMHP'.

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Coronavirus: state of supply of hospital drugs

Heard from FAMHP

Coronavirus: stand van zaken van de bevoorrading van geneesmiddelen voor ziekenhuizen

Coronavirus: état des stocks de médicaments hospitaliers

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Coronavirus: joint statement by the FAMHP and the BVAS to respond to the concerns of healthcare professionals in the field

Heard from FAMHP

Coronavirus: gezamenlijke verklaring van het FAGG en de BVAS om een antwoord te geven op de bekommernissen van de gezondheidszorgbeoefenaar op het terrein

Coronavirus : déclaration commune de l’AFMPS et de l’ABSYM afin d’apporter des réponses aux inquiétudes des professionnels de la santé du terrain

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Prescribing on substance name

Heard from FAMHP

Voorschrijven op stofnaam (VOS): versie 8 van de "Operationele regels voor het voorschrijven op stofnaam in de medische en farmaceutische praktijk en in het elektronisch medisch dossier"

Prescription en dénomination commune internationale (DCI) : version 8 des « Règles opérationnelles pour la prescription en DCI dans la pratique médicale et pharmaceutique et dans le dossier médical électronique »

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Identity theft: attempts to order medical equipment on behalf of the FAMHP

Heard from FAMHP

Identiteitsdiefstal: pogingen om in naam van het FAGG medisch materiaal te bestellen

Usurpation d'identité : tentatives de commande de matériel médical pour le compte de l'AFMPS

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MSLS - Global Results MSL Activities During the COVID-19 Pandemic

Survey

As a result of the COVID-19 pandemic, the activities of MSLs including how they engage with KOLs and other healthcare providers is quickly evolving. The MSL Society conducted a survey to gain insights into how the current COVID-19 pandemic is impacting the activities of Medical Science Liaisons globally including working virtually and engaging with KOLs.

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Coronavirus: the FAMHP continues to supply essential medicines for intensive care and keeps hospitals informed on a daily basis.

Heard from FAMHP

Coronavirus: het FAGG blijft essentiële geneesmiddelen leveren voor de intensieve zorgen en houdt de ziekenhuizen dagelijks op de hoogte.

Coronavirus : l’AFMPS continue de fournir les médicaments indispensables pour les soins intensifs et informe les hôpitaux au jour le jour

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Coronavirus: Alternative Test Protocol (ATP) for Surgical Mouth Masks

Heard from FAMHP

Coronavirus: Alternative Test Protocol (ATP) voor chirurgische mondmaskers

Coronavirus : protocole de test alternatif (Alternative Test Protocol, ATP) pour les masques buccaux chirurgicaux

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Coronavirus: measures for paracetamol to be relaxed

Coronavirus: maatregelen voor paracetamol worden versoepeld

Coronavirus : assouplissement des mesures concernant le paracétamol

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Risk of haemolysis associated with the use of hydroxychloroquine (PLAQUENIL) in the treatment of COVID-19.

Heard from FAMHP

Risico van hemolyse verbonden aan het gebruik van hydroxychloroquine (PLAQUENIL) in de behandeling van COVID-19

Risque d’hémolyse associé à l’utilisation d’hydroxychloroquine (PLAQUENIL) dans le traitement du COVID-19

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Coronavirus: measures taken by the FAMHP and the stakeholders concerned to continue to guarantee the supply of oxygen

Heard from FAMHP

Coronavirus: maatregelen van het FAGG en de betrokken stakeholders om de bevoorrading van zuurstof te blijven garanderen

Coronavirus : mesures prises par l'AFMPS et les partenaires concernés pour continuer à garantir l'approvisionnement en oxygène

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Coronavirus: circular for care institutions on the (outsourcing of the) manufacture and reprocessing of medical devices and their accessories

Heard from FAMHP

In order to combat shortages of medical devices, care institutions have proceeded to manufacture medical devices and their accessories or to reprocess used medical devices. The FAMHP defines the modalities by means of a circular in order to offer more options to care institutions.

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Coronavirus: refinement of the measures taken by the FAMHP to avoid drug shortages

Heard from FAMHP

Coronavirus: verfijning van de maatregelen die het FAGG heeft genomen om tekorten aan geneesmiddelen te vermijden

Coronavirus : affinement des mesures prises par l'AFMPS pour éviter la pénurie de médicaments

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Coronavirus: Belgian directive for the reuse of surgical masks and FFP2/FFP3 masks in the context of the COVID-19 epidemic

Heard from FAMHP

A national guideline is available for the reprocessing of surgical masks and FFP2/FFP3 masks which allows reuse by cleaning, disinfecting or sterilising.

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Updated guidelines for the labelling and packaging of medicinal products for human use

Heard from FAMHP

Marketing authorisation holders of a medicinal product for human use are required to follow certain guidelines for the labelling and packaging of medicinal products. These guidelines have recently been updated.

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Coronavirus: details of the measures taken by the FAMHP to avoid shortages of medicines

Heard from FAMHP

Details van de maatregelen die het FAGG heeft genomen om tekorten aan geneesmiddelen te vermijden.

Détail des mesures prises par l’AFMPS pour éviter les pénuries de médicaments.

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Coronavirus: hydroxychloroquine and chloroquine, beware of their elimination half-life and of the risk of drug interactions

Heard from FAMHP

Flash VIG-news: hydroxychloroquine en chloroquine, pas op voor hun eliminatie-halfwaardetijd en voor het risico op geneesmiddeleninteracties

Flash VIG-news : hydroxychloroquine et chloroquine, attention à leur demi-vie d’élimination et aux risques d’interactions médicamenteuses

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Coronavirus: hydroxychloroquine, chloroquine and Kaletra (lopinavir + ritonavir) are distributed in a controlled way for a better follow-up of the treatment.

Heard from FAMHP

Coronavirus: hydroxychloroquine, chloroquine en Kaletra (lopinavir + ritonavir) worden voor een betere opvolging van de behandeling op een gecontroleerde manier verdeeld in België

Coronavirus : hydroxychloroquine, chloroquine et Kaletra (lopinavir + ritonavir) sont distribués de manière contrôlée en Belgique, pour une surveillance accrue des traitements

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Coronavirus: measures taken by the FAMHP to avoid drug shortages

Heard from FAMHP

Coronavirus: maatregelen van het FAGG om geneesmiddelentekorten te vermijden

Coronavirus : mesures de l’AFMPS pour éviter les pénuries de médicaments

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Coronavirus: guidelines for checking the compliance and suitability of certain surgical face masks

Heard from FAMHP

The FAMHP issues guidelines for checking the compliance and suitability of surgical face masks The guidelines are for companies not producing in accordance with European standards and for healthcare establishments and authorities ordering the masks.

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Nitrosamines in medicinal products: report results of risk assessments for impurities

Heard from FAMHP

Update 30.03.2020: the deadline for the first part of the risk assessment has been prolonged from 26th March 2020 to the 1st of Octobre 2020.

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Coronavirus: FAMHP seizes postal parcels containing counterfeit and other illegal medicines against COVID-19

Heard from FAMHP

Coronavirus: FAGG neemt postpakketten met namaak en andere illegale geneesmiddelen tegen COVID-19 in beslag

Coronavirus : l'AFMPS saisit des colis postaux contenant des médicaments contrefaits et d’autres médicaments illégaux contre le COVID-19

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Coronavirus: Belgian guideline for the management of clinical trials during the coronavirus pandemic

Heard from FAMHP

A national guideline is available to complement European guidelines for the management of clinical trials during the coronavirus pandemic.

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Urgent mesures from the Luxembourg Authorities

Here you will find an order which regulates the supply of medicines in Luxembourg and a general ban on the export of medicines.

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Coronavirus: which drugs are used in the fight against COVID-19

Heard from FAMHP

Coronavirus: welke geneesmiddelen worden gebruikt in de strijd tegen COVID-19?

Coronavirus : quels sont les médicaments utilisés dans la lutte contre la COVID-19 ?

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Operation PANGEA XIII: Belgian customs and FAMHP seize 203 parcels containing more than 23 000 illegal or counterfeit products

Heard from FAMHP

Operatie PANGEA XIII: Belgische douane en FAGG nemen 203 pakketten met meer dan 23 000 illegale of nagemaakte producten in beslag

Opération PANGEA XIII : la douane belge et l’AFMPS saisissent 203 colis contenant plus de 23 000 produits illégaux ou contrefaits

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PRAC March 2020

Heard from FAMHP

Suspension of ulipristal acetate, review of liver injury risk – Testing and treatment recommendations for fluorouracil, capecitabine, tegafur and flucytosine – Review of ifosfamide cancer medicines

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Coronavirus: European guidelines for the management of clinical trials during the coronavirus pandemic

Heard from FAMHP

European guidelines for the management of clinical trials during the coronavirus pandemic are available.

Read more

ICPM 2020 is postponed

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News of Pharma.be regarding SARS-CoV 2

The hospital UZ Leuven has informed that they have postponed all non-essential visits by external parties. This also applies to CROs and monitoring visits by pharmaceutical or device companies.

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NVFG Medical Affairs Dag 2020 CANCELLED

In the context of COVID-19, the NVFG Medical Affairs Day of 12 March 2020 will be cancelled.

Read more

Healixia New Year's Event

On Thursday 23 January 2020, we organised our very first Healixia New Year's Event.

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President and Vice-president of Healixia elected!

We are proud to announce that Erik Present (former BeAPP) is the first President of Healixia. Marian Coquel (former BRAS) is our first Vice-president. They are appointed for a period of 2 years.

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Survey on the use of benzodiazepines and related substances in sleep disorders in Belgium

Heard from FAMHP

Bevraging over gebruik van benzodiazepines en aanverwante middelen bij slaapstoornissen in België

Enquête sur l’utilisation des benzodiazépines et apparentés dans le cadre des troubles du sommeil en Belgique

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Clamoxyl I.V.-I.M. available again but commercialization scheduled for end 2021

Heard from FAMHP

Clamoxyl I.V.-I.M. opnieuw beschikbaar maar stopzetting van commercialisatie voorzien voor eind 2021

Le Clamoxyl I.V.-I.M. est de nouveau disponible mais l’arrêt de sa commercialisation est prévu pour fin 2021

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Pilot project on simultaneous national scientific advice starts 1 February 2020

Heard from FAMHP

The EU-Innovation Network announces a pilot project for simultaneous national scientific advice (SNSA) to strengthen early regulatory support for innovation. The pilot project kicks off with developing a best practice model starting 1 February 2020.

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