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 veterinary 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 authorisation 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 veterinary use should be sent electronically to the FAMHP.

Each email can only contain one declaration request (1 email per declaration) and must clearly indicate the subject 'D' and the name of the concerned medicinal product. The application must contain the different documents requested, separately (1 document = 1 file attached). Applications must be sent from the mailbox of the qualified person (QP), the responsible person or the legal representative of the company and must contain an extension specific to the company (hotmail addresses, gmail, skynet, ... will not be accepted). They must be sent to the generic address : D-ED-declarations@afmps-fagg.be .

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 153,86 € (payable to the account of FAMHP

IBAN: BE 28 6790 0219 4220
BIC: PCHQBEBB

mention code: 700100.

Contact

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

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

General telephone number: +32 (0)2 528 40 00
Mailbox:  D-ED-declarations@afmps-fagg.be 

Last updated on 20/12/2017