The conditions for being approved as a qualified person are described in article 84 of the Royal Decree dated 14th December 2006 (French version) (part 1 - part 2).
If you meet these conditions and wish to receive approval as a qualified person please send the following documents to FAMHP (Federal Agency for Medicines and Health Products), DG Inspection / Division Industry / File Management Entity & Persons Recognition, Place Victor Horta 40 box 40, 1060 Brussels:
- A copy of your diploma(s). All diplomas obtained abroad must already be recognised by the appropriate authority
- A certificate of the training programme signed by the qualified person at the company where you did your training
- A copy of your identity card
- form 65 correctly completed
The approval can only be granted when all the conditions mentioned in the Royal Decree dated 14th December 2006 (French version) (part 1 - part 2) are met and when all the required documents are in our possession.
For the verification of the application file submitted by the natural person regarding the qualified person (QP), as well as for the subsequent management of that file for e.g. the granting of a derogation that allows him / her to perform the function of QP for several MIA holders, a fee must be paid, and this according to Article 12bis, §1 / 1, paragraph 2 of the Medicines Act.
The amount of the fee is 1738.00 €. This amount will be subject of an invoice sent to you by the FAMHP.
Contact
Email : inspection@fagg-afmps.be