All medicines need to be shown to be safe and efficacious before they are allowed to be used. This is as true for animal treatments as it is for human, although there are some extra approvals required for animal medicines regarding consumer safety (i.e. ensure our food is safe to eat) and environmental safety.
There is a stringent registration process for licencing animal medicines; any new medicine needs to be supported by a highly detailed dossier that establishes the safety, quality and efficacy of a product. This dossier is reviewed by independent experts working on behalf of European and national regulators before agreeing to allow it to be used. They conduct a comprehensive assessment, including a benefit-risk analysis, to decide whether to recommend that the medicine be allowed on the market.
The safety assessment does not stop there; once a product is placed on the market, it is subject to statutory post-marketing surveillance or pharmacovigilance programmes to monitor for, and detect, any unforeseen problems. At the same time, the manufacturing standards are also monitored through regular inspections and testing. If at any time the authorities believe that a product poses a risk they can order its use restricted or even withdraw it from the market.
Where a manufacturer wishes to market a new (innovative) product throughout the EU, there is a Centralised Procedure. They submit their dossier on safety, quality and efficacy to the European Medicines Agency (EMA). Once approved, the EU-wide marketing authorisations are valid in all Member States. Currently this approach is mandatory for certain biotechnology products, although applicants can request this for other innovative products.
In addition, each member state in Europe has its own independent regulatory authority, which can perform its own independent scientific evaluations of veterinary medicinal products. This approach provides a degree of flexibility; where a disease is local to a country or area, the approval can be granted there.
Legislation governing the registration of veterinary medicines has evolved to reflect scientific progress and the increasing levels of cooperation within EU Members States to facilitate the single market. In 2019 the legislation was further strengthened particularly to stimulate investment and support innovation, take into account “novel therapies”, modernise the system of post-marketing surveillance and improve the functioning of the single market. The new legislation also opens up the Centralised Procedure to all types of animal health products as of 2022.
Part of the authorisation process includes guidance on acceptability of the practises applied by the the animal health industry on labelling and packaging, including recommendations to facilitate the approval of the packaging and labelling proposals.
The EMA’s CMDv (Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary) and QRD (Working Group on Quality Review of Documents) set out guidelines on this topic: