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

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.

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

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

Coronavirus: swabs: compliance verification

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.

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

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).

Coronavirus: EMA gives positive recommendation for AstraZeneca vaccine

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.

Pilot project on Clinical Trial Regulation (CTR): webinar on the new temporary procedure for submission of initial dossiers

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.

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.

Influenza vaccine: vaccination of at-risk groups completed, vaccine can be delivered to people of low-risk groups

Based on data collected from pharmacists by the FAMHP, it appears that all category A patients who requested an influenza vaccine, have received their vaccine. The limited remaining stock of influenza vaccines can be distributed to the rest of the population, preferably to people over 50 years old or people working in vital sectors. Influenza vaccination remains appropriate until the flu peak has been reached, which has currently not happened yet.

Coronavirus: weekly overview of 14 January 2021 on adverse reactions of COVID-19 vaccines

From 7 January 2021 onwards, the FAMHP publishes a weekly overview on the adverse reactions reported in Belgium following the administration of a COVID-19 vaccine. By being fully transparent, the FAMHP aims to increase confidence in COVID-19 vaccines.

Amended legislation: drug precursors added to list of scheduled substances

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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