TOPICS

TOPICS

Pharmacovigilance

Νew EU Regulation (658/2014)

Νew EU Regulation (658/2014)

Regulation N 658/2014 of the European Parliament

Medicines under additional monitoring

Medicines under additional monitoring

Medicines under additional monitoring

EC Regulation on implementation of the Pharmacovigilance legislation published in the OJEU

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)

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)

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

Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010

Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010

Directive 2010/84/EU of the European Parliament and of the Council

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