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CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine

Autor(es): European Medicines Agency
Fonte: London; EMEA; June 25, 2009. 15 p.
Repositório Complementar ID: 287
Resumo: This document applies to the pharmacovigilance plan as part of the risk management plan introduced with the authorisation application of mock-up pandemic influenza vaccines according to the CHMP Guideline on dossier structure and content of pandemic influenza vaccine marketing authorisation application (CPMP/VEG/17/17/03). It also applies to the pharmacovigilance plan of vaccines authorised outside the context of the mock-up dossier and to be used during an influenza pandemic.