Authorisation RD 14/12/2006
According to articles 12b and 12c of the law dated 25th March 1964 (French version) concerning medicines, the manufacture of medicines or intermediary products on Belgian territory requires authorisation. This authorisation is also required if the medicine is manufactured for export.
Authorisation is needed both for total or partial manufacture and for work such as dividing, packaging or presentation.
Authorisation is furthermore required for imports from third countries and for wholesale of medicines.
The Royal Decree dated 14/12/2006 (French version) (part 1 - part 2) relating to medicines for human and veterinary use, defines the conditions for obtaining these authorisations (manufacture and imports : articles 74 to 83 – wholesale distribution : articles 90 to 99). The application for authorisation 14/12/2006 (a new application, an application to modify an authorisation or an application to modify approved installations) with Appendix 1 : Area of Application of the Authorisation must be introduced with all the required documents to the federal agency for medicines and health products (FAMHP) by e-mail to the mailbox firstname.lastname@example.org.
The amount of the fee to be paid when applying for a new authorisation is 1.508,26€.
For the modification of an authorisation or the modification of an approved installation the amount is 60,82€.
The fee must be paid into the FAMHP account:
IBAN CODE: BE28 6790 0219 4220
BIC/ Swift code: PCHQBEBB