Emea Veterinary Medical Products

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Veterinary Medicinal Products Regulation - European …

https://www.ema.europa.eu/en/veterinary-regulatory/overview/veterinary-medicinal-products-regulation

EMA's role in implementing the Regulation. Progress updates. The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) updated the rules …

Veterinary medicines: regulatory information

https://www.ema.europa.eu/en/veterinary-medicines-regulatory-information

This section of the website provides information on the regulation of medicines for veterinary use in the European Union (EU). It particularly concerns the centralised …

Veterinary Medicines | European Medicines Agency

https://www.ema.europa.eu/en/about-us/who-we-are/veterinary-medicines

The European Medicines Agency's (EMA) Veterinary Medicines Division oversees veterinary medicines throughout their lifecycle. This includes the provision of guidance …

Veterinary product information templates | European …

https://www.ema.europa.eu/en/veterinary-regulatory/marketing-authorisation/product-information/veterinary-product-information-templates

The European Medicines Agency's (EMA) provides templates for product information for use by applicants and marketing authorisation holders of veterinary …

Assessment and control of DNA reactive (mutagenic) …

https://www.ema.europa.eu/en/assessment-control-dna-reactive-mutagenic-impurities-veterinary-medicinal-products-scientific

The purpose of this guideline is to provide a practical framework that is applicable to the identification, categorisation, qualification, and control of these mutagenic impurities, to …

VICH GL11 Impurities in new veterinary medicinal …

https://www.ema.europa.eu/en/vich-gl11-impurities-new-veterinary-medicinal-products-scientific-guideline

This document provides guidance for registration applications on the content and qualification of impurities in new veterinary medicinal products produced from …

A Look at the European Medicines Agency | FDA

https://www.fda.gov/animal-veterinary/animal-health-literacy/look-european-medicines-agency

The EU’s definition of a veterinary medicinal product closely matches the definition of an animal drug in the United States. In the EU, a company can market a veterinary …

Sterilisation of the medicinal product, active substance, …

https://www.ema.europa.eu/en/sterilisation-medicinal-product-active-substance-excipient-primary-container-scientific-guideline

Document history. Guidance is provided on the selection of appropriate methods of sterilisation for sterile products. Although, terminal sterilisation using a reference …

Importing Animal and Veterinary Products | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-animal-and-veterinary-products

The Center for Veterinary Medicine (CVM) is the FDA center responsible for regulating animal and veterinary products. These products include animal food and feed, pet …

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