Authorisation for manufacturing and distribution

According to articles 88 and 99 of the regulation (EU) 2019/6  concerning medicines for veterinary use, the manufacture of medicines or intermediary products on Belgian territory requires authorisation. This authorisation is also required if the medicine is manufactured for export.

A manufacturing authorisation is required for 

  • the manufacture of veterinary medicinal products, even if intended exclusively for export;
  • any of the steps in the manufacturing process of a veterinary medicinal product or for bringing a veterinary medicinal product to its final state: manufacture of the pharmaceutical form, primary packaging, secondary packaging, analysis, batch certification; 
  • importation of veterinary medicinal products

From 28 January 2022, before applying to the Federal Agency for Medicines and Health Products (FAMHP) for a new or updated manufacturing or wholesale authorisation, you must check that your organisation is correctly registered in OMS. We would like to refer you to the European Medicines Agency (EMA) for more information. 

 Application for an authorisation

The amount of the fee related to the making of the authorisation is included in the annual fee or in the cost of a complementary inspection, not included in the amount of this annual fee. Therefore no proof of payment has to be provided when submitting an application for an authorisation.

FAQ's

How to apply for an authorisation to manufacture medicines ? (see French - Dutch)

How to apply for an authorisation to distribute medicines ? (see French - Dutch)

How to apply for an authorisation to export medicines ? (see French Dutch)

How to apply for an authorisation to hold medicines ? (see French - Dutch)

Last updated on 01/07/2022