Marketing Authorisation Division (Human)


Marketing Authorisation Division (Human)

General e-mail address


General phone number

+ 32 2 528 40 00

Key tasks

  • The following up of MA applications for medicinal products for human use
  • Receipt and validation of MA applications
  • Evaluation and management, in the broadest sense, of the application files for a MA or for a registration of homoeopathic and herbal medicines and processing of applications for amendments to existing MA and registrations
  • Receipt and administrative monitoring of ASMFs
  • Coordination and follow-up of applications in function of the deadlines
  • Ensuring the link between the pharmaceutical industry, national and international competent authorities such as EMA, internal and external assessors and partner institutions such as the WIV-ISP
  • Ensuring the secretariat of the CGH-CMH, HCG-HCM and CKG-CMP
  • Active participation in consultations with other competent authorities, such as CMDh or with BRAS regarding regulatory affairs
  • Drafting of PARs
  • Administrative closing of files and delivery of Mas
  • Issuing STA
Last updated on 09/10/2017