Riziv/Inami and Fagg/Afmps have emitted together with BeMVO a joint declaration confirming and specifying various elements related to the implementation of FMD in Belgium.
The different aspects addressed concern amongst others the starting date, the FMD scope for Belgium , the alignment with Grand Duché du Luxembourg, Instructions for package design and submission of variations, major milestones of the implementation, …
The European Medicines Verification Organisation (EMVO) is pleased to announce that the EMVO On- boarding Partner Portal (OBP Portal) is up and running. To facilitate the on-boarding of pharmaceutical companies to the EU Hub, the user-friendly web-based portal will guide pharmaceutical companies step by step through the process.
Launch Announcement Letter of the EMVO On-boarding Partner Portal
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.