Guidance documents

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

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VeterinaryRegulatory and procedural guidance
Safety and residues: Biological substances other than immunologicals

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

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VeterinaryRegulatory and procedural guidanceResearch and developmentScientific guidelines
Scientific guidelines for veterinary medicines

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for veterinary medicines. Guidelines reflect a harmonised approach of the EU Member...

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VeterinaryRegulatory and procedural guidanceScientific guidelines
Variations not requiring assessment (veterinary medicines)

Guidance is available from the European Medicines Agency (EMA) on variations for centrally authorised veterinary medicines not requiring assessment under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6). This includes information on the documents that marketing authorisation holders need to submit as part of the variation...

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VeterinaryRegulatory and procedural guidance
Fees payable to the European Medicines Agency

The European Medicines Agency (EMA) charges fees for the services it provides. The rules relating to the Agency's fees are governed by the fee regulation (Council Regulation (EC) No 297/95) and its implementing rules, as well as the pharmacovigilance fee regulation (Regulation (EU) No 658/2014).

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HumanVeterinaryCorporateFeesRegulatory and procedural guidanceMedicines
Transferring a veterinary marketing authorisation

Guidance is available from the European Medicines Agency (EMA) on transferring a veterinary marketing authorisation in the form of questions and answers (Q&As). The Q&As provide an overview of the EMA's position on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the post-authorisation phase...

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VeterinaryRegulatory and procedural guidance
Supporting innovation

A range of services is available from the European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and European Commission to support innovative medicines and associated technology developments in the European Union (EU).

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HumanVeterinaryRegulatory and procedural guidanceInnovationResearch and developmentScientific advice