Questions and Answers to support the implementation of - European ...

Abbreviations:
• ADR – Adverse Drug Reaction
• CAP – Centrally Authorised Product
• CHMP - Committee for Medicinal Products for Human Use
• CMDh – Coordination Group for Mutual Recognition & Decentralised Procedure – human
• CSP – Core Safety Profile
• DCP – Decentralised Procedure
• DDPS – Detailed Description of the Pharmacovigilance System
• DLP – Data Lock Point
• EC – European Commission
• eCTD – electronic Common Technical Document
• EEA – European Economic Area
• EMA – European Medicines Agency
• ENCePP – European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
• EU – European Union
• EU PAS Register – EU electronic register of post-authorisation studies
• EURD list – List of European Union Reference Dates and frequency of submission of Periodic Safety
Update Reports
• GVP – Good Pharmacovigilance Practices
• HMA – Heads of Medicines Agencies
• ICSR - Individual Case Safety Reports
• MA – Marketing Authorisation
• MAH – Marketing Authorisation Holder
• MEdDRA – Medical Dictionary for Regulatory Activities
• MRP – Mutual Recognition Procedure
• MS – Member State
• NAP – Nationally Authorised Product
• PAS – Post-authorisation Studies
• PASS – Post-authorisation Safety Studies
• PL – Package Leaflet
• PRAC – Pharmacovigilance and Risk Assessment Committee
Questions and Answers to support the implementation of the Pharmacovigilance
legislation - UPDATE, NOVEMBER 2012
EMA/228816/2012 Page 28/29