Manufacturing activity as a sub-contractor

Declaration of manufacturing activity as a sub-contractor 

Within the framework of article 12b, §1, paragraphs 1 and 5 of the law dated 25th March 1964 (French version) about medicines requiring authorisation to manufacture medicines or intermediate products or to import them, and article 74 of the Royal Decree as applied on 14/12/2006 (French version) (part 1 - part 2) relating to medicines for human and veterinary use,  FAMHP  (Federal Agency for Medicines and Health Products)  has foreseen the need for the manufacturer to have a « declaration of manufacturing activity as a sub-contractor for a medicine for human use  »

A declaration of manufacturing activity as a sub-contractor must be made for any total or partial manufacture of a drug for which a marketing authorization is not granted in Belgium, but is granted in another country in the European Union.

The request for a declaration of manufacturing activity as a sub-contractor for a medicine for human use should be sent to FAMHP.

The Minister or his delegate communicates his decision to the applicant within 90 days from the date of the introduction of an admissible application. It may require additional information. In this case the 90-day period is suspended until the requested information is provided.

The documents that need to be supplied are mentioned in the request form mentioned above.

The declarations of manufacturing activity as a sub-contractor are subject to a payment of 150,83 € payable to the account of the FAMHP

IBAN: BE 28 6790 0219 4220 
BIC: PCHQBEBB 

mention code: 700100.

Contact

Federal Agency for Medicines and Health Products
DG Inspection - Division Authorizations

Cell Authorizations, Declarations and Certificates
Eurostation II, 6th floor
Place Victor Horta, 40 box 40
1060 Brussels

General telephone number: +32 (0)2 528 40 00

Last updated on 06/01/2017