Types of marketing authorisation

When applying for a licence to market a particular medicine, there are several types of licences to choose from. These different types of licences are based on the Veterinary Medicinal Products Regulation. Each type of marketing authorisation has its own legal basis.

The application types are referred to in the European application form that has to be used for all procedures. Different rules apply to the various types of applications and not all types are possible in all situations.

The most important types of marketing authorisations will be described.

Submission of an application

If you want to apply for a marketing authorisation, you will first need to determine which type of marketing authorisation you wish to apply for based on the information on the various types of marketing authorisations.

You will then need to submit all the required information to the Veterinary Medicinal Products Unit. You can read how to do this under Submission of a dossier.

You should include all required documentation.

Required documents

All requirements relating to the structure and submission of the dossier are described in Annex II to the Veterinary Medicinal Products Regulation and in Volume 6 Notice to Applicants. The requirements differ per type of marketing authorisation.

Always include a Summary of Product Characteristics (SPC), label and package leaflet. These must be drawn up in accordance with the established format. For more information on the SPC, labelling and package leaflet, please refer to the CMDv's guidance documents regarding the SPC, labelling and package leaflets.

Additional information

If you have any further questions about an application procedure, please contact the Veterinary Medicinal Products Unit.