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The European Public Assessment Report (EPAR) reflects the scientific conclusion reached by the Committee for Proprietary Medicinal Products (CPMP) at the end of the centralised evaluation process and provides a summary of the grounds for the CPMP Opinion in favour of granting a marketing authorisation for a specific medicinal product. It is made available by the EMEA on their website, after deletion of commercially confidential information. The legal basis for its creation and availability is contained in Article 12 (4) of Council Regulation (EEC) No. 2309/93. The EPAR is a collective of 8 modules, of which the "Scientific Discussion" module highlights the main parts of the CPMP assessment leading to the CPMP opinion. The content of the Scientific Discussion module is essentially identical to the summarized assessment report, minus any confidential information, that must be drafted prior to the issuance of a positive opinion. Its content reflects the documentation submitted by the applicant, together with the scientific discussion at CPMP meetings. The EPAR is updated throughout the authorisation period as changes to the original terms and conditions of the authorisation (i.e. variations, pharmacovigilance issues, specific obligations) are made.
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