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 is moving on 1 March 2021
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.materiaal zoals beschreven in deze wet zijn onderhevig aan de uitvoeringsbesluiten en moeten zich regulariseren als stoelgangbank.
EMA’s Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of the COVID 19 vaccine being developed by CureVac.
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.
The European Commission granted a conditional marketing authorisation for the AstraZeneca vaccine against COVID-19. 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 recommendation for AstraZeneca’s vaccine against COVID-19, named “COVID-19 Vaccine AstraZeneca”. It is the third vaccine to be authorised for marketing in the European Union. This recommendation has meanwhile been confirmed by the European Commission.
From mid-February 2021, a reservation system with time slots will be used for the submission of initial dossiers for the Clinical Trial Regulation (CTR) pilot project. This procedure will be explained during a webinar on 4 February 2021 at 2 PM.
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.