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 » (Dutch or French)
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.
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-EDemail@example.com .
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. More information about fees can be found here. The overview regarding declarations of manufacturing activity as a sub-contractor is only available in Dutch or French. An invitation to pay the amount will be sent to you by the FAMHP via an invoice.
Federal Agency for Medicines and Health Products
DG Inspection - Division Authorisations - Cell Authorisations, Declarations and Certificates
General telephone number: