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Guideline on good pharmacovigilance practices (GVP)

www.ema.europa.eu

Modalities for expedited reporting ..... 56 106 VI.Appendix 3.1. Interim arrangements ..... 56 VI.Appendix 3.1.1. Interim arrangements applicable to marketing authorisation holders ....107 61 108 VI.Appendix 3.1.2. Interim arrangements applicable to competent authorities in Member

  Reporting, Expedited, Expedited reporting

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