Post-orphan medicinal product designation procedures: Guidance for sponsors

This guideline covers the information and procedures applicable to orphan designated products.

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Guideline on good pharmacovigilance practices (GVP) - Module VI – Collection, management and submiss

Guideline on requirements for the production and control of immunological veterinary medicinal produ

What’s new in Pharmacovigilance? QPPV update (Issue 2, July 2017)