Healixia News - page 14

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

“Off-Label prescription” in Belgium.

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

December 10, 2021

IFAPP Today newsletter - nov/dec 2021

Source: IFAPP

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

December 9, 2021

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

December 9, 2021

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

December 9, 2021

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

December 6, 2021

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

November 30, 2021

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

November 25, 2021

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.

November 23, 2021

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