MedicineVeterinaryAuthorised

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Corporate

This page lists the European Medicines Agency's general guidance documents relating to veterinary medicines

VeterinaryRegulatory and procedural guidance

The European Medicines Agency's scientific guidelines on the safety and residues of veterinary medicines help applicants prepare marketing authorisation applications. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy...

Regulatory and procedural guidance

The European Medicines Agency's scientific guidelines on the biological substances other than immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.

VeterinaryRegulatory and procedural guidanceResearch and developmentScientific guidelines

PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach...

HumanEarly accessRegulatory and procedural guidanceResearch and development