Widely used procedures for marketing of a medicinal product in the EU are the Mutual Recognition and Decentralised Procedures. The Mutual Recognition Procedure (MRP) is obligatory since 1 January 1998, for medicinal products already having a marketing authorisation in one Member State (MS) and with the intention to be marketed in the other MS. The Decentralised Procedure (DCP) applies in case at the time of application no marketing authorisation exists in any of the Member States (European Commission. Authorisation procedures).
MRP and DRP are applying i.e. in case of following situations:
- known active substances as indicated in Article 8(3) of Directive 2001/83/EC
- generic medicinal products • well established use
- known active substances in new combination
- traditional herbal medicinal products.
The dossiers for application of marketing authorisation include the following documents which have to be written according to the guidelines of the common technical document (CTD) (ICH. Common Technical Document).
- Module 2.4 Nonclinical Overview
- Module 2.5 Clinical Overview
- Module 2.6 Nonclinical Written and Tabulated Summaries
- Module 2.7 Clinical Summaries
As part of the application dossier, actions for monitoring and minimising of any potential risk associated with use of the medication must be defined. This is done in form of
- Risk Management Plan (RMP)
The marketing authorisation is valid for a period of 5 years, after which this must be renewed based on the risk-benefit evaluation of the concerned medical product (CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures).
The application for renewal is supported i.e. by
- Updated Module 2.4 Nonclinical Overview
- Updated Module 2.5 Clinical Overview
Once a product is on the market, all records of reported safety events must be collated and assessed. This is done in form of
- Periodic Benefit-Risk Evaluation Report (PBRER); previously the Periodic Safety Update Report), as described by ICH E2C(R2).
- Revision of product information such as Summary of Product Characteristics (SmPC), product information leaflet (PIL) and labelling is provided for the local market in all requested languages (Dutch, French, and German) by native speakers.