The "guidance to applicants" was drawn up by the European Commission in consultation with the competent authorities of the Member States and the European Medicines Agency (EMA) and adopted at the meeting of the Standing Committee on Veterinary Medicinal Products. It is available in all EU languages on the website of the European Commission.

The purpose of this guide is to help competent authorities and marketing authorisation holders (MAHs) to comply with their obligations under Regulation (EU) 2019/6. It details certain definitions in the Regulation concerning: the veterinary medicinal product, the marketing authorisation procedures and the legal bases such as generics/hybrids but also the limited markets and exceptional circumstances and the protection of the data provided in the marketing authorisation application dossiers or their variations.