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. It is also important to note that the Marketing Authorization process is dynamic and the underlying dossier must be regularly updated to ensure that scientific progress and new regulatory requirements are science i technicaL buLLetinissue n 33 /deceMber 2009introductionauthor: arash ghaLaMkarPour, Phd, reguLatory affairs associate, sgs Life science servicesWhile there are three different Procedures , each one is not applicable in every case.
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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