This Product Index includes medicines approved in the Member States of the European Union according to the procedure for Mutual Recognition.
The Mutual Recognition and the Product Index
The mutual recognition procedure is based on that medicines are evaluated and approved by a Reference Member State (RMS) followed by a 90-day period where the Concerned Member States (CMS) consider the RMS assessment report. If the CMS agree with the assessment they should issue a marketing authorisation within 120 days from the start of the procedure. If the CMS does not agree with the RMS decision they can refer the application to arbitration, the Committee for Proprietary Medicinal Products (CPMP) at the European Medicines Evaluation Agency (EMEA) will handle the arbitration.