Veterinary products that make a claim of properties for treating or preventing disease, or are used in animals and have a pharmacological, immunological or metabolic action are regulated in Europe under a Community centralised authorisation procedure. Directive 2001/82/EC, as amended by Directive 2004/28/EC, outlines the Community code relating to veterinary medicinal products (VMPs). Any product placed on the market must have a marketing authorisation and companies must provide a data dossier to support their application; the pharmacologically active substance must have been approved and listed. The EU registration process ensures that only those products of a defined standard, which have been thoroughly tested and carefully reviewed by independent experts, reach the marketplace. The application for marketing authorisation shall include all the scientific documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product.
Certain products for animal use fall outside the scope of the veterinary medicine’s regulation. These may include, for example, insect repellents, or products applied topically to disinfect teats and udders. Such products are regulated under the Biocidal Products Regulation, as are disinfectants used for animal housing.
Bibra scientists have, for many years, provided expert support to companies working in the market for active substances – be it pharmaceuticals, veterinary products, or biocides. Our advice is particularly sought on the toxicological risks posed by the non-active components of any formulation – excipients, processing aids, and manufacturing impurities. With our wide-ranging skills in the hazard and risk assessment of chemicals, data searching, exposure modelling, and extensive use of Structure Activity Relationship (SAR) and Threshold of Toxicological Concern (TTC) concepts, we are your ideal partner to support your veterinary product registration.
Legislation on animal feed is harmonised at European Union (EU) level. It applies principally to feed for farmed livestock, but also covers feed for horses, pets, farmed fish, zoo and circus animals, and creatures living freely in the wild.
As a manufacturer of animal feed additives your product must be authorised in accordance with the provisions of EU Regulation 1831/2003 and that you have to submit a substance dossier to the European Commission. This dossier should contain data and studies which demonstrate the efficacy and safety of the product for animals, consumers and the environment.
We have many years of experience providing advice on toxicological issues relating to food and feed additives, and can help support your regulatory submissions.
Support on veterinary product and animal feed additive registrations
- Applications for market authorisations and approvals
- Expert reports and dossier submissions
- Hazard and risk assessment of non-active formulation components and additives
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