Obligation to register antigenic rapid tests and antigen self-tests made available in Belgium by manufacturers, importers, recorded distributors

According to article 5 §3 of the law of 22 December 2020, the persons referred to in article 3 (manufacturers, importers, registered distributors) inform the FAMHP of the rapid antigen tests that are made available in Belgium. 

According to article 6 of the Royal Decree of 11 May, manufacturers, importers or registered distributors inform the FAMHP of the self-tests they make available in Belgium. 

Manufacturers, importers and registered distributors must therefore notify the FAMHP of the rapid antigen tests and antigenic self-tests they make available in Belgium; this notification must be made directly via our online applications (webportal).

For general questions about the webportal, please contact: notifications.meddev@fagg-afmps.be
For technical problems, please contact: support.portal@fagg-afmps.be
For all other questions related to this information or to the SARS-CoV-2 antigen tests, please contact: Antigen@fagg-afmps.be
 

Last updated on 13/08/2021