CMDh STANDARD OPERATING PROCEDURE ON THE PROCESSING OF PSUR SINGLE ASSESSMENT PROCEDURES FOR NATIONA
This Standard Operating Procedure covers the processing of the Periodic Safety Assessment Report (PSUR) single assessment procedures (PSUSAs) from the pre-submission phase to the CMDh decision making process, which concerns only nationally authorised products (NAPs). In this paper, the term ‘nationally authorised product’ encompasses medicines authorised through Mutual Recognition and Decentralised procedures and purely nationally authorised products that are subject to the single assessment as per the EURD list.
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