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.
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.
Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages
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.
The FAMHP took a number of exceptional measures in the first months of the COVID-19 pandemic to ensure sufficient availability of surgical face masks that meet the minimum quality requirements for use as medical devices. These exceptional measures will be terminated as of 1 February 2021.
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.
Coronavirus: European Commission gives conditional market authorisation for vaccine against COVID-19
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).
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. This opinion still has to be confirmed by the European Commission. Belgium purchased the vaccine and will use it immediately in its vaccination campaign.
Update on the guidance document to assist clinical trials sponsors as part of the pilot project of the 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.
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.
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.