Application Routes in the EU - National Procedures
In the European Union (EU), the application routes for obtaining marketing authorisation for medicinal products can be categorised into two main procedures: the centralised procedure and the national procedures.
The centralised procedure is applicable for certain types of medicinal products, such as biotechnology-derived products, orphan drugs, and products for human use containing new active substances. It involves submitting an application directly to the European Medicines Agency (EMA) for evaluation. If approved, the marketing authorisation is valid in all EU member states.
For products not eligible for the centralised procedure, national procedures are followed. These procedures involve submitting applications to individual national regulatory authorities of each EU member state where the marketing authorisation is sought. Each national authority evaluates the application independently based on its national requirements, including quality, safety, and efficacy data. If granted marketing authorisation, it is valid only in the respective member state.
The national procedures require compliance with the EU legal framework and relevant guidelines, but there may be variations in requirements and timelines across different member states. Applicants need to provide the necessary documentation and data to meet the specific requirements of each national authority.
To streamline the process, the EU has introduced mechanisms to facilitate cooperation and harmonisation among member states, such as the Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP). These procedures allow for the recognition of assessments conducted by one member state and subsequent mutual recognition by other member states.
In conclusion, while the centralised procedure offers a single marketing authorisation valid throughout the EU, national procedures are followed for products not eligible for centralised evaluation. Applicants need to comply with the requirements of individual member states and may utilise mechanisms like MRP and DCP to facilitate the process.
