De specificaties voor MAH met betrekking tot de product- en verpakkingsgegevens die moeten worden geüpload naar de Belgische repository, van toepassing in België en Luxemburg, zijn bijgewerkt. Het uploaden van de nationale code is NIET langer verplicht.
Klik hier om de wijzigingen te raadplegen.
The Wave 2 registration to the Belgian Medicines Verification System for Marketing Authorisation Holders is open.
MAHs who register before end December 2017 will benefit from a 25% discount on the registration fee if the payment of the fee is received latest by end January 2018. We invite the MAH’s who desire to register to do so as soon as possible.
Please consult the MAH Registration section on this website for more information on the procedure and download the appropriate documents.
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.