EMA is currently preparing a set of guidelines on new pharmacovigilance legislation called GVP, which are replacing the previously applicable Volume 9A of the Rules Governing Medicinal Products in the EU. The already finished chapters (modules) and other information about the GVP are available on the EMA website.
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Documents for pharmacovigilance branch
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Questions and answers on the amended Act on...
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GVP – Good Pharmacovigilance Practices
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Where can one find the guidelines for Good...