Application guidance

The European Medicines Agency provides guidance documents to companies and individuals involved in developing and marketing veterinary medicines in the European Union. These include guidance on dossier requirements, submission dates, procedures as well as templates and checklists for applications.

The Notice to Applicants (NtA) is intended to facilitate the interpretation and application of the Community pharmaceutical legislation. It has been prepared by the European Commission, in consultation with the competent authorities of the Member States and the European Medicines Agency. It is not legally binding, and in case of doubt, applicants should refer to the appropriate Community Directives and Regulations.

As of 1 January 2016, the use of electronic Application Forms (eAF) is mandatory for all application procedures (authorisations, variations and renewals).

As of 1 January 2017, it is mandatory for applicants to use the eSubmission Gateway / Web Client for all veterinary procedural submissions to the Agency. For more information, including links to guidance on registration with the system, see:

Guidance

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