Regulation (EU) 2019/6 provides standards for veterinary medical products (VMPs) in the European Union, ensuring the protection of human and animal health as well as the environment. A marketing authorisation is required for any product placed on the market, and companies must provide a data dossier to support their application; the pharmacologically active substance must be approved and listed. The EU registration process ensures that only items that meet a specific standard and have been extensively tested and examined by independent experts are allowed to enter the market.
The application for marketing authorization must include all scientific documents required to demonstrate the VMP’s quality, safety, and efficacy.
Insect repellents and products applied topically to disinfect teats and udders are examples of products for animal usage that fall beyond the scope of these regulations. They, like disinfectants used in animal housing, are regulated by the Biocidal Products Regulation.
For many years, Maven scientists have provided experienced help to companies working in the active substance sector, whether it’s pharmaceuticals, veterinary products, or biocides. The toxicological concerns provided by non-active components of any formulation – excipients, processing aids, and manufacturing impurities – are particularly sought after. We are your ideal partner to support your veterinary product registration with our extensive skills in chemical hazard and risk assessment, data searching, exposure modelling, and extensive use ofthe threshold of toxicological concern (TTC)and the concepts of structure-activity relationships (SARs).
Animal Feeds:Animal feed legislation is harmonised at the EU level. It mostly pertains to feed for farmed livestock, but it also includes feed for horses, pets, farmed fish, zoo and circus animals, and wild animals.
Animal feed additives must be approved in accordance with Regulation (EC) No 1831/2003 (as modified, with the most recent version being Regulation (EU) No 2019/962). Manufacturers of feed additives must submit to the European Commission a substance dossier containing data and analysis confirming the product’s efficacy for animals as well as its safety for animals, humans, and the environment.
Maven Expertise includes:
- Market authorisation and approval applications for veterinary products.
- Expert reports on veterinary products and dossier submissions.
- Assessment of human health risks associated with the use of a veterinary product.
- Expert reports and an update to a health risk assessment for an over-the-counter veterinary product.
- Non-active formulation components and additives are evaluated for hazard and risk.
- Contaminants in animal feed are evaluated for their potential to cause harm.
