Home - Healixia

November 28, 2024

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?

July 11, 2024

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.

June 14, 2024

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).

May 13, 2024

IFAPP Today newsletter - May 2024

Source: IFAPP

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

April 29, 2024

IFAPP Today newsletter - April 2024

Source: IFAPP

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

March 14, 2024

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.

March 14, 2024

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

January 19, 2024

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.

January 16, 2024

IFAPP Today newsletter - January 2024

Source: IFAPP

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

November 6, 2023

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.

October 23, 2023

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.

October 5, 2023

IFAPP Today newsletter - October 2023

Source: IFAPP

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

September 20, 2023

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.

September 14, 2023

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

September 7, 2023

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

September 7, 2023

IFAPP Today newsletter - September 2023

Source: IFAPP

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

August 17, 2023

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.

July 24, 2023

IFAPP Today newsletter - July/August 2023

Source: IFAPP

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

July 17, 2023

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

July 13, 2023

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

June 19, 2023

IFAPP Today newsletter - June 2023

Source: IFAPP

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

June 16, 2023

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

June 9, 2023

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

June 1, 2023

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

May 25, 2023

News from our sponsor QbD

Source: IFAPP

QbD acquires Turnstone and Michor.

May 15, 2023

IFAPP Today newsletter - May 2023

Source: IFAPP

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

May 4, 2023

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.

April 17, 2023

IFAPP Today newsletter - April 2023

Source: IFAPP

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

April 4, 2023

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

March 28, 2023

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

March 23, 2023

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

March 23, 2023

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

March 16, 2023

IFAPP Today newsletter - March 2023

Source: IFAPP

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

March 2, 2023

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

February 22, 2023

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.

February 22, 2023

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

February 22, 2023

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

February 14, 2023

IFAPP Today newsletter - February 2023

Source: IFAPP

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

January 27, 2023

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

January 27, 2023

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

January 17, 2023

IFAPP Today newsletter - January 2023

Source: IFAPP

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

January 12, 2023

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

January 10, 2023

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).

January 10, 2023

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.

January 10, 2023

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!

January 9, 2023

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

December 23, 2022

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.

December 23, 2022

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

December 23, 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

November 24, 2022

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

November 21, 2022

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

November 8, 2022

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

October 7, 2022

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

October 7, 2022

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

October 6, 2022

IFAPP Today newsletter - October 2022

Source: IFAPP

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

October 3, 2022

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

September 30, 2022

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

September 29, 2022

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

September 29, 2022

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

September 15, 2022

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

September 12, 2022

IFAPP Today newsletter - September 2022

Source: IFAPP

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

August 30, 2022

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

August 30, 2022

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

August 30, 2022

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

July 14, 2022

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

July 5, 2022

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

Source: FAMHP

June 7, 2022

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

June 2, 2022

IFAPP Today newsletter - June 2022

Source: IFAPP

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

June 2, 2022

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

June 2, 2022

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

May 24, 2022

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

May 18, 2022

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

May 17, 2022

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

May 16, 2022

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

May 12, 2022

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.

May 6, 2022

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!

May 5, 2022

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.

April 29, 2022

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

April 26, 2022

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

April 25, 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

March 28, 2022

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

March 28, 2022

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

March 22, 2022

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

March 22, 2022

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

March 14, 2022

Message from the IFAPP President

An update on the collaboration between IFAPP and IFAPP Academy

March 14, 2022

IFAPP Today newsletter - March 2022

Source: IFAPP

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

February 28, 2022

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

February 25, 2022

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?

February 25, 2022

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

February 24, 2022

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

February 21, 2022

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

February 21, 2022

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

February 17, 2022

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

February 10, 2022

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.

February 7, 2022

IFAPP Today newsletter - February 2022

Source: IFAPP

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

February 7, 2022

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

February 3, 2022

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

January 31, 2022

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

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

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

December 16, 2021

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

December 16, 2021

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

December 16, 2021

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.

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

November 10, 2021

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

November 4, 2021

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

November 4, 2021

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

October 28, 2021

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”.

October 22, 2021

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

October 19, 2021

FPM Annual Symposium

TRIALS and TRIBULATIONS
Shaping a Bright New Future for Pharmaceutical Medicine

11-12 NOVEMBER 2021 - virtual conference

October 18, 2021

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.

October 11, 2021

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.

October 7, 2021

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 ?”.

October 5, 2021

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

October 5, 2021

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

October 5, 2021

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

September 16, 2021

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

August 30, 2021

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

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

August 17, 2021

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

August 17, 2021

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

August 17, 2021

Source: FAMHP

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

July 20, 2021

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.

July 16, 2021

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

July 16, 2021

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

July 12, 2021

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).

July 12, 2021

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.

July 9, 2021

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

July 2, 2021

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

July 2, 2021

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

July 1, 2021

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)

July 1, 2021

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

July 1, 2021

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.

June 16, 2021

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

June 10, 2021

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.

May 27, 2021

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

May 27, 2021

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

May 26, 2021

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

Source: FAMHP

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

May 12, 2021

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

May 11, 2021

Source: FAMHP

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

April 15, 2021

Source: IFAPP

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

April 8, 2021

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

April 7, 2021

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

April 6, 2021

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

April 2, 2021

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?

April 2, 2021

News from beTransparent.be

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

February 22, 2021

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.

February 11, 2021

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

February 11, 2021

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.

February 9, 2021

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

February 5, 2021

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.

January 29, 2021

IFAPP Today newsletter

Source: IFAPP

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

January 29, 2021

Source: FAMHP

Future training CTR

January 25, 2021

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

January 25, 2021

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

January 25, 2021

Update on the Mdeon procedure

Source: Mdeon

Some important updates on the Mdeon procedures.

January 19, 2021

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

January 14, 2021

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

January 14, 2021

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

January 14, 2021

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.

January 8, 2021

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

January 6, 2021

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

December 29, 2020

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.

December 3, 2020

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.

November 10, 2020

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

November 6, 2020

IFAPP Today newsletter

Source: IFAPP

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

October 30, 2020

Influenza vaccine: absolute priority for protection of most vulnerable people

Source: FAMHP

Source: IFAPP

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

October 8, 2020

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.

October 8, 2020

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.

October 6, 2020

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.

October 6, 2020

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

Source: FAMHP

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.

September 18, 2020

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.

September 8, 2020

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

September 7, 2020

Healixia traject - Let's connect

Whenever and wherever

We have worked out a traject of multiple online events.

August 31, 2020

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.

August 31, 2020

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.

August 31, 2020

In Memoriam, Stefaan Vancayzeele

Thursday August 27th, Stefaan Vancayzeele has passed away.

August 27, 2020

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.

August 19, 2020

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.

June 23, 2020

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

Source: FAMHP

PharmaBoardroom, a leading website for C-Level executives working in Healthcare and Life Sciences interviewed Healixia President Erik Present.

May 6, 2020

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

May 6, 2020

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

May 6, 2020

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

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.

April 16, 2020

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

April 15, 2020

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

April 15, 2020

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.

April 9, 2020

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

April 8, 2020

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.

April 6, 2020

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.

April 6, 2020

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.

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.

Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The results of these risk assessments can now be reported.

March 26, 2020

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

March 26, 2020

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.

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

March 24, 2020

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.

March 10, 2020

ICPM 2020 is postponed

Considering developing circumstances, IFAPP (the International Federation of

Associations of Pharmaceutical Physicians and Pharmaceutical Medicine) is postponing

ICPM2020, March 25-26-27.

March 10, 2020

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.

March 10, 2020

NVFG Medical Affairs Dag 2020 CANCELLED

In the context of COVID-19, the NVFG Medical Affairs Day of 12 March 2020 will be cancelled.

January 23, 2020

Healixia New Year's Event

On Thursday 23 January 2020, we organised our very first Healixia New Year's Event.

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.

Healixia events

Healixia webinar: Early access/ Urgent request /Compassionate use : Recent developments in Luxembourg

Healixia session on drug shortages

Regulatory session on Medical Devices

Healixia News

New: Legal/Compliance & Ethics Education Group

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

IFAPP Today newsletter - June 2024

IFAPP Today newsletter - May 2024

IFAPP Today newsletter - April 2024

Healixia at the VFSO Pharma Career Day 2024

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

IFAPP Today newsletter - March 2024

IFAPP Today newsletter - February 2024

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

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

IFAPP Today newsletter - January 2024

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

Healixia Clinical Conference 2023

IFAPP Today newsletter - October 2023

Energizing Strategic meeting!

The QbD Group acquires life sciences consultancy Azierta

Customs and the FAMHP seize 1.5 tonnes of illegal medicines

IFAPP Today newsletter - September 2023

IN MEMORIAM Noël Wathion

IFAPP Today newsletter - July/August 2023

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

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

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

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

The FAMHP publishes its annual report 2022

IFAPP Today newsletter - June 2023

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

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

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

News from our sponsor QbD

IFAPP Today newsletter - May 2023

Interview with our President Erik Present in PharmaBoardroom

IFAPP Today newsletter - April 2023

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

Reform of medicines reimbursement procedures by Riziv-Inami

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

New system for financing the surveillance of the medical devices market

IFAPP Today newsletter - March 2023

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

Healixia award 2023: nominations

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

Five new drug precursors added to list of scheduled substances

IFAPP Today newsletter - February 2023

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

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

IFAPP Today newsletter - January 2023

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

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

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

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

Belgium publishes the first report on antimicrobial resistance

Medical Affairs survey in collaboration with NVFG

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

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

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

IFAPP Today newsletter - November/December 2022

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

Simultaneous national scientific advice pilot project: launch of phase 2

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)

MedSafetyWeek 2022: annual campaign to promote adverse reactions reporting

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

Amended legislation: drug precursors added to list of scheduled substances

IFAPP Today newsletter - October 2022

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

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

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

Warning against the use of illegal TKTX ointment after applying tattoos

PRAC September 2022 –Reviews of topiramate and pholcodine medicines started

IFAPP Today newsletter - September 2022

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

The FAMHP is looking for a new administrator-general

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

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

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