Authorisations Division


Authorisations Division

General e-mail address

  • Manufacturing and distribution authorisations, API-registrations, CPP’s and other certificates for industry:









General phone number

+ 32 2 528 40 00

Key tasks

The key tasks of the Authorisations Division are receiving authorisation applications, validating such applications and ultimately delivering authorisations. This includes:


  • Manufacturing authorisations – GMP
  • Authorisations for manufacturing, import and distribution of APIs
  • Notification of medical brokers
  • Wholesale authorisations
  • Export declarations
  • CPPs
  • Accreditations for blood, cells and tissues
  • Authorisations of establishment of retail pharmacies
  • Registrations of pharmacies
  • Authorisations of substances that fall under the RD of 12 April 1974
  • Drugs precursors that need to meet the United Nations Convention of 1988; there has been a significant increase in the number of export authorisations as a consequence of a new licensing requirement for medicines based on ephedrine
  • Narcotics and psychotropic substances that need to meet the United Nations Conventions of 1961 and 1971
Last updated on 09/10/2017