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

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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 SafetyUpdate 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 CommitteeQuestions and Answers to support the implementation of the Pharmacovigilancelegislation - UPDATE, NOVEMBER 2012EMA/228816/2012 Page 28/29
• PSMF – Pharmacovigilance System Master File• PSUR – Periodic Safety Update Report• Q&A – Question and Answer• QPPV – Qualified Person responsible for Pharmacovigilance• QRD – Quality Review of Documents• RMP – Risk Management Plan• RMS – Reference Member State• SME – Small & Medium Sized Enterprise• SmPC – Summary of Product Characteristics• WS – worksharing• XEVMPD – eXtended EudraVigilance Medicinal Product Dictionary• XEVPRM – eXtended EudraVigilance Medicinal Product Report MessageQuestions and Answers to support the implementation of the Pharmacovigilancelegislation - UPDATE, NOVEMBER 2012EMA/228816/2012 Page 29/29
Page 5: If available, the PSMF number assig
Page 8 and 9: From those elements included in the
Page 10 and 11: 3. The pharmacovigilance system mas
Page 12 and 13: For the centralised procedure, init
Page 14 and 15: The Agency will have to make public
Page 16 and 17: 4.12. Could only Principal Investig
Page 19 and 20: NCAs consider that during the trans
Page 21 and 22: II for CAP) in order to avoid the n
Page 23 and 24: 5.24. Where will the PSUR workshari
Page 25 and 26: legislation. For more information r
Page 27: authorisation holder should exercis

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