Changes to the Parallel Import Entity within the Marketing Authorisation Division (variations and renewals)

The FAMHP has decided to no longer handle files on parallel import in the separate Parallel Import Entity of the Marketing Authorisation Division (variations and renewals). This decision was made to guarantee the analogy with reference drugs and to better follow up on procedures.

Organisation of the tasks of the Parallel Import Entity

Concretely, the tasks of the Parallel Import cell is integrated into the other existing cells and teams of the Licensing for Market department (variations and renewals).

 

  • The File Management team will now be responsible for the management of:
    • MRP Type II clinical variations, IB clinical variations and five-year renewals
    • NP Type II clinical variations, IB clinical variations and five-year renewals
    • MRP and NP notifications
    • Parallel import files: new requests, variations and five-year renewals
  • The Administrative Support team will be responsible for the upload of the parallel import files and sending the licenses.
  • The Update Data Model team will implement the data model of parallel import files.

Questions and contact

For questions regarding parallel import and for questions about other files of the Marketing Authorisation Division (variations and renewals), you can contact the Point of Contact Variations and Renewals via postlicensing@fagg-afmps.be.

Last updated on
29/05/2019