Parallel import remains an important mechanism within the European pharmaceutical market. It allows a medicine authorized in one EU country to be imported and marketed in another EU country, such as the Netherlands, provided a parallel trade license is granted by the Dutch Medicines Evaluation Board (CBG-MEB).
Several important updates have recently been introduced to policy document MEB-14 (Parallel import: marketing authorisation and maintenance). Below are the most relevant changes for regulatory professionals, Marketing Authorization Holders (MAH) and parallel importers:
- Centralized products handled via EMA
In the Introduction it is now clearly stated that for centrally authorized products, applications for parallel distribution must now be submitted through the European Medicines Agency (EMA). - Supply classification aligned with the Dutch reference product
The parallel-imported product will receive the same supply classification as the Dutch reference product. Additional documentation is required if the classification has changed. - New guidance for complex biological active substances
Specific assessment criteria have now been introduced for parallel products containing complex biological active substances, an important development given the increasing role of biologics and biosimilars in the market. - Updated approach for SmPCs and package leaflets
If the Dutch reference product is no longer authorized, the SmPC of another medicine may serve as the basis for keeping the package leaflet up to date. However, the policy clarifies that the entire leaflet text should not automatically be fully aligned with that of an alternative product. - Controlled Access Programs and distribution systems addressed
New instructions have been added for situations where the Dutch reference product is subject to a Controlled Access Program (CAP) or Controlled Distribution System. - Additional documentation requirements for different MRP/DCP procedures
Where the parallel product and Dutch reference product have not gone through the same MRP (Mutual Recognition Procedure) or DCP (Decentralised Procedure), the application dossier must now include a declaration explaining the relationship between the proposed parallel trade license holder and the MAH in the country of origin.
Companies involved in parallel trade and regulatory affairs should ensure their dossiers and internal processes are updated accordingly. In case you want to parallel import medicines or need any assistance in the application process, kindly contact us at [email protected]
