Qualified person

The conditions to be approved as a qualified person are laid down in Article 84 of the Royal Decree of 14 December 2006.

If you meet these conditions and wish to be approved as a qualified person (QPHum), you must send the following documents to the email address industry@fagg-afmps.be.

  • A copy of your university degree(s): any university degree acquired abroad must first be approved by the competent authority:
  • Your original internship certificate, signed by the responsible qualified person from the company where you completed your internship.
  • A copy of your identity card.
  • Form 65 (fully completed).

The requested recognition can only be granted when all the conditions mentioned in the Royal Decree of 14 December 2006 are met and  when we get all the requested documents. The application must contain the requested documents, each attached separately (one document = one attached file).

A competent person candidate must complete the internship in a company with a manufacturing authorisation for veterinary medicinal products or a manufacturing authorisation for medicinal products for human use (implementation of Articles 84-86 of the Royal Decree of 14 December 2006). The internship certificate must be signed by the QP, QPHum or QPVet of the company where the internship was performed.

Federal Agency for Medicines and Health Products
DG Inspection - Industry Division/File Management and Persons Recognition Entity

Last updated on 23/12/2022