Electronic submission of applications
Applications can be submitted by email to mch-mlm@fagg-afmps.be. Applications submitted electronically are processed in the same way as those sent by post. This method of submission is a fully-fledged alternative to submitting accreditation dossiers and is in line with the Act of 5 May 2014, which enshrines the principle of "once-only data collection" and recognises the validity of documents that are submitted electronically.
Application for recognition as a human body material establishment:
The procedure stipulated in the Royal Decree of 28 September 2009 laying down the general conditions that must be met by human body material banks, intermediaries and production establishments in order to be recognized is set out in Circular 550. This procedure aims to standardize the content of applications for recognition or renewal, with a view to more transparency and collecting relevant and useful statistical data.
Applications may be submitted by email to mch-mlm@fagg-afmps.be or by registered post to the following address:
Federal Agency for medicines and health products
DG Inspection – Authorisations division – Certification Human Body Materials Entity
Avenue Galilée 5/03
B-1210 BRUSSELS
Application for recognition as an importing human body material establishment:
To apply for recognition as an importing establishment, please use the template.
We would like to emphasise that, even for a one-off import, you need to be recognised as an importing establishment and must submit an application.