Point of contact division Marketing Authorisation (variations and renewals)

You can contact the contact point of the division Marketing Authorisation (variations and renewals) by phone and by mail.

Questions are addressed as quickly as possible, if possible within ten business days.

Which questions are handled by the contact point of the division Marketing Authorisation (variations and renewals)?
 
  • Every request for information on the acquisition, approval, revocation or radiation of a marketing authorisation or parallel import authorisation for human use in the broadest sense and which is not concretely linked to an ongoing file.
  • Resending of automatic e-mails (these are e-mails sent by the internal MeSeA database of the FAMHP when processing a file). When processing this request, it may be determined that the file is not included in the MeSeA database. In this case, the company must submit the file again to the Dispatching team.
  • Information on the status of a file, including all questions regarding the progress of ongoing files.
    If the questions falls within the scope of the file, you can contact the file manager.
    If the question falls outside of the scope of the file, send the question to the general contact address of the contact point of the division Marketing Authorisation – variations and renewals. The question will be forwarded to the correct contact person.
  • Concrete questions about fees to be paid for the submission of new authorisations, variations or renewals
  • Questions about correction of approved documents. 

    Note: this is for the correction of minor errors.

How do you submit a question to the contact point of the division Marketing Authorisation (variation and renewals)?
 

For confidentiality purposes, this is preferably done by e-mail to postlicensing@fagg-afmps.be.

If you are a consultant for a certain company, you must attach a proof of delegation of power/power of attorney. This is to be able to guarantee confidentiality. If our employees have no clear link between the person requesting information and company, the information will not be forwarded to the person requesting information.

The more information you can provide, the more quickly and exactly your question can be handled. So pose your question as clearly and concretely as possible.

Which information is required?
 

Depending on the question, we need the following information:

  • Questions about automatic e-mails:
    • cover letter
    • name of the medicinal product
    • preferably the procedure number
  • Questions about the status of a file:
    • name of the medicinal product
    • ID number
    • procedure number
    • if necessary, concrete description of question/problem arising
  • Questions about fees:
    • Questions about the calculation of a fee for:
      • a new authorisation:
        • type of medicinal product (medicinal product for human use or veterinary use)
        • type of procedure (NAT/DCP/MRP) - role of the FAMHP (RMS/CMS)
        • legal basis (full application, generic application, etc.)
      • a variation:
        • type of medicinal product (medicinal product for human use or veterinary use)
        • type of procedure (NAT/DCP/MRP) - role of the FAMHP (RMS/CMS)
        • number of brands (only applicable to horizontal groups and worksharing)
      • a renewal:
        • type of medicinal product (medicinal product for human use or veterinary use)
        • type of procedure (NAT/DCP/MRP) - role of the FAMHP (RMS/CMS)
    • Problems with payments:
      • file references
      • description of the problem
  • Request for correction of approved documents:
    • final approved document(s)
    • clean and annotated document(s)
    • correct and detailed description of the error found in the approved documents.

      Attention! This is for the correction of minor errors. For a major error, you are asked to submit a variation/notification to correct it.

 

Contact

tel: +32 2 528 40 04 (every business day from 9 AM to 1 PM)
e-mail: postlicensing@fagg-afmps.be

Last updated on 08/07/2020