10.03.2015

Requirements on Submissions for PSURs updated (MRP/DCP, National)

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An updated list of "Requirements on Submissions for Periodic safety update reports (PSUR) to National Competent Authorities (NCAs) for products authorised via National Procedures, MRP and DCP (NAPs)", document CMDh/317/2014/Rev2, dated February 2015 has been released by the CMDh.


The recent version Rev2 together with a corresponding track change version can be downloaded from the CMDh website.

Notable changes included the addition of the missing entries for Luxembourg, an administrative correction for Greece (Eudralink accepted) and a general recommendation to use CESP (where accepted) for the submission of PSURs for products authorized in MRP/DCP or purely national procedures.

[Source: CMDh website]

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