PL EN

HMA: Recommendation for Marketing Authorisation Holders on the Pharmacovigilance System and Risk Management Plan in the Mutual Recognition and Decentralised Procedures.

12.08.2011
This CMDh guidance document aims to provide specific guidance for RMS and CMS on the submission of data related to Pharmacovigilance systems, the necessity for submission of Risk Management Plans (RMP) and on how the RMP is assessed during MRP and DCP.

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