MAH – Fees for submission of Variations – Update from FAMHP

The FAMHP is following the implementation plan from CMDh/EMA where the notification of the safety features can be included in each newly introduced filing with impact on the product information (five-yearly renewal, IA, IB or II variation) by using the updated version of the QRD template. The company pays the fee of the initial file without any additional cost for the implementation of the safety features.

Besides the QRD, also the mock-up must be adapted. The mock-up can also be included in the file without an additional cost. The mock-up must only be submitted if the implementation of the safety features has an impact on the readability.

For medicines using the national procedure, the implementation of the safety features can be grouped if the readability of the mock-up is not impacted. The fee for such submission is similar to a grouped IA-variation.

Belgian regulation

The Federal Agency for Medicines and Health Products (famhp/fagg/afmps) has published the guidelines and Q&A documents related to the Falsified Medicines Directive.

They are available in Dutch:

And in French: