Transcription of Marketing Authorization Procedures in the …
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Marketing Authorization Procedures in the …
Marketing Authorization Procedures in the euroPean union Making the right choiceThe three described Procedures are published by the European Commission in consultation with the competent authorities of the Member States, the European Medicines Agency (EMEA), and interested parties. The three Procedures that are currently applicable are:Mutual Recognition Procedure (MRP) Decentralized Procedure (DCP) Centralized Procedure (CP) In each case, the legal basis for a Marketing Authorization application may vary from a full application and submission of all data regarding the pharmaceutical, pre-clinical and clinical trials, to bibliographic or a well-established medicinal use application, or another basis, such as a generic application.
Marketing authorization Procedures in the euroPean union – Making the right choice The three described procedures are published by the European Commission in consultation with the competent
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