Request for information to the marketing authorisation holders for medicinal products for human use, in view of Brexit

The Federal Agency for Medicines and Health Products (FAMHP) wants to get a better view of all upcoming new MRPs (Mutual Recognition Procedures), DCPs (Decentralised Procedures) as well as of all RMS switches (Reference Member State) resulting from Brexit. Marketing authorisation holders are asked to provide the FAMHP with the necessary information as well as the information regarding the sites for which the UK is actually responsible.

In view of Brexit the FAMHP plans to take additional RMS slots for medicinal products for human use starting from 01.01.2019.

In order to manage the additional dossiers according to the actual state of the art and within the legal timelines, the FAMHP needs amongst others to have the correct number of competent resources in place on time. To achieve this the FAMHP would like to ask all marketing authorisation holders for their Belgian RMS dossier forecast for the period 01.01.2019 through 31.12.2021.

Should an authorisation holder consider switching from UK to Belgium for RMS (so-called RMS switches), the FAMHP would also like to get the list of concerned procedures as soon as possible.

Moreover the FAMHP would like a listing of all UK sites and non European sites for which the UK was acting as European inspectorate regarding the EU GMP certificate.

Please provide us with the necessary information by sending the completed template to prelicensing@fagg-afmps.be. We are looking forward to your answer and would be very grateful if you could send it to us by 01.08.2018.

Any input received up to the 31.08.2018 will be taken into account by the FAMHP as well.

Last updated on
01/08/2018