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 guidelines

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...

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Regulatory 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
PRIME: priority medicines

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...

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HumanEarly accessRegulatory and procedural guidanceResearch and development
PRAC recommendations on safety signals

Each month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines.

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HumanRegulatory and procedural guidancePharmacovigilance
MenQuadfi
meningococcal group A, C, W-135 and Y conjugate vaccine
Meningitis, Meningococcal
Date of authorisation:
Revision: 12
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MedicineHumanAuthorised
Clinical efficacy and safety guidelines

The European Medicines Agency's scientific guidelines on the clinical efficacy and safety of human 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...

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HumanRegulatory and procedural guidanceScientific guidelines
Real-world evidence

The European Medicine Agency's (EMA) scientific guidelines on real-world evidence aim support the use of real-world data in regulatory decision-making.

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HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines