For a non-innovative drug authorized in one member state, what is the BEST strategy for extending the license in other member states?

Using the Mutual Recognition Procedure (MRP) is the best strategy for extending the license of a non-innovative drug in other member states. The MRP is designed to facilitate the marketing of medicinal products that have already been authorized in one EU member state by allowing that authorization to be recognized in other member states without the need for duplicative assessments.

When a drug is approved in one member state, the MRP enables the license holder to request that other member states recognize the initial assessment and authorization. This significantly streamlines the process, reducing the time and resources needed compared to applying for separate licenses in each state.

In contrast, filing an entirely new application for each state would require the applicant to undergo the full evaluation process in each individual country, leading to delays and increased costs. The parallel trade license option is not applicable in this context as it typically pertains to the legal distribution of a drug that is already marketed, rather than the authorization process. Submitting variation applications is also not suitable for acquiring an initial authorization in new member states, as these are used for modifying existing authorizations rather than for initial market entry.

Thus, the MRP is the optimal route for extending a license across multiple member states efficiently and effectively.