Licensing and Approval of Antimicrobial Agents for Use in Animals

Veterinary medicines and vaccines are indispensable for the treatment and prevention of farm animal and pet diseases around the world. To ensure that these medications are high quality and appropriately produced, countries require that animal health medicines are manufactured to specific standards of quality, with proven safety and efficacy. The responsible authority in a given country must authorize that a veterinary medicine can be manufactured, sold, and used. The marketing authorization, also known as “registration” or “license,” implies that the responsible authority has approved not only the product to be marketed, but also the conditions that will characterize the use of the product. These conditions become part of the labelling, packaging, and information leaflets of the product and include (i) the characteristics of the active substance, its purity and concentration, and the complete composition of the medicinal product; (ii) the pharmaceutical form in which the medicine will be delivered (e.g., tablet, powder, cream, solution for injection), and the way it will be administered to the animal (e.g., injection, by mouth, in feed or water, or by topical application); (iii) the animals for which it is intended to be used, including specific ages and weights where relevant; (iv) what diseases or conditions it can be used to prevent, treat, or control, also known as the “indications”; (v) the dosages for each indication, the duration of treatment, and the withdrawal period, which means the number of days the medication must be withheld from farm animals prior to their produce entering the food system; and (vi) other circumstances regarding its use, including storage, shelf life, safety warnings, disposal instructions, and possible contra-indications. The sponsor develops this data package (or “application” or “dossier”) according to the testing requirements and standards of the authorizing legislation in place in the jurisdiction. Authorised veterinary medicines have a clear positive benefit associated with their use while considering the risk to public health, animal health, and the environment. The authorization and production of veterinary medicinal products also require manufacturing controls for the active substance(s) and the final product and sampling and testing of products. Regular manufacturing site inspections and pharmacovigilance ensure continued monitoring once the medicine has been authorised and is being marketed. Additionally, many countries have monitoring systems in place to ensure compliance with maximum residue limits (MRLs). This means that any residues of the medicine in food from its use in food-producing animals must remain below the established safe levels for the consumer.