Pharmacovigilance

Best Practice Guide on handling of PSURs in MR-DC procedures

Best Practice guide on handling of PSURs in EU PSUR Worksharing - Update September 2016

DDPS declaration

Following a 12 month pilot phase and based upon positive feedback from industry and agencies, the CMDv has agreed to continue the use of the ‘DDPS declaration form’ on an indefinite basis. The declaration form may be used by an Applicant in all application procedures (Decentralised, Mutual Recognition and National) for new marketing authorisations to notify National Competent Authorities of any previous assessment and approval of the same version of the DDPS. Further clarification on using the DDPS declaration form is available in the above documents and from the chosen RMS