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Νew EU Regulation (658/2014)
Regulation N 658/2014 of the European Parliament
Pharmacovigilance
Medicines under additional monitoring
Medicines under additional monitoring
EC Regulation on implementation of the Pharmacovigilance legislation published in the OJEU
The Commission Implementing Regulation (EU) No 520/2012
Amended process for electronic reporting of adverse reactions to the National Organization for Medicines (EOF)
Greek original announcement regarding the new electronic reporting requirements for Greece
CMDh GUIDANCE DOCUMENT FOR DECLARATION FORM SUBMISSION DDPS (DETAILED DESCRIPTION PHARMACOVIGILANCE SYSTEM) ALREADY APPROVED BY A COMPETENT AUTHORITY (CA) of the EEA (including Iceland, Norway, Liechtenstein and the EMA)
GUIDANCE DOCUMENT FOR DECLARATION FORM SUBMISSION DDPS