Pandemic influenza

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This page lists the European Medicines Agency's standard operating procedures and work instructions related to pandemic influenza.

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Document(s) Language Status First published Last updated Effective Date
Work instructions for influenza-pandemic manual 1.1 establishment of the joint European Medicines Agency-industry task force on pandemic-influenza vaccines (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza pandemic manual 1.2 organisation of annual joint-European-Medicines-Agency-industry-task-force meeting and meetings with individual manufacturers (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 1.3 holding annual joint-European-Medicines-Agency-industry-task-force meeting and meetings with individual manufacturers (English only) adopted 2009-06-22 2012-10-01 2012-09-16
Work instructions for influenza-pandemic manual 1.4 establishment of European Medicines Agency pandemic task force and evaluation project team (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 2.1 organisation of ad-hoc joint-European-Medicines-Agency-industry-task-force meeting and meetings with individual manufacturers (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 2.2 holding ad-hoc joint-European-Medicines-Agency-industry-task-force meetings and meetings with individual manufacturers (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 2.3 European Medicines Agency follow-up actions (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 3.0 mobilisation of crisis teams and initiation of World Health Organization phase-6 actions (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 4.1 European Union endorsement of pandemic strain (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 4.3 European Union recommendation for reference strain (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 5.1 organisation of European Medicines Agency task-force meetings (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 5.2 holding European-Medicines-Agency-task-force meetings (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza pandemic manual: 6.0 European Medicines Agency Task Force (ETF) minutes, action plans (draft/final) and future ETF meeting schedules (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 7.1 core-dossier-approved marketing authorisation: rolling review (prior to submission of type-II variation to introduce the pandemic strain) (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 7.2 non-core-dossier-approved marketing authorisation: rolling review (prior to submission of marketing-authorisation application) (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 8.1 evaluation of a type-II variation to introduce the pandemic strain to an influenza vaccine (core-dossier-approved marketing authorisation) (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza pandemic manual: 8.2 Evaluation of a conditional marketing authorisation for a pandemic influenza vaccine (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 8.3 evaluation of variations (including urgent changes) (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 8.4 other post-approval procedures (e.g. extensions of marketing authorisation, notifications) (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza pandemic manual (IPM): 9.1 Committee for Medicinal Products for Human Use opinion further to IPM 8.1: evaluation of a type II variation to introduce the pandemic strain to an influenza vaccine (core-dossier-approved marketing authorisation) (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual (IPM) 9.2 CHMP opinion further to IPM 8.2 evaluation of a conditional marketing authorisation for a pandemic-influenza vaccine (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 9.3 CHMP opinion on variations (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual (IPM) 9.4 CHMP opinion on variations for urgent review which require changes to Commission decision annexes - urgent safety review procedures (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 10.0 need for Commission decision (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 11.0 Commission decision (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 12.1 periodic safety update reports (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 12.2 evaluation of specific obligations (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual 12.3 pharmacovigilance (English only) adopted 2009-06-22 2012-10-01 2012-09-26
Work instructions for influenza-pandemic manual: Glossary of terms used in work instructions in annex I of the European Medicines Agency influenza crisis-management plan (English only) adopted 2006-09-20 2012-10-01 2012-09-26