Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)

Pre-authorisation procedural guidance is available from the European Medicines Agency (EMA) on initial marketing authorisation prcoedures for centrally authorised veterinary medicines under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6).

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) applies from 28 January 2022.

These Q&As provide an overview of EMA's advice on issues that are typically addressed in discussions or meetings with applicants before submitting a marketing authorisation application and throughout the assessment.

They are updated regularly to reflect new developments, to include guidance on further pre-authorisation procedures and to reflect the implementation of new European legislation.

New or revised Q&As are marked as 'New' or 'Rev.' with the relevant date.

Separate guidance is available for marketing authorisation applications submitted on or before 27 January 2022 to be concluded in accordance with Directive 2001/82/EC and Regulation (EU) 726/2004:

Pre-submission meetings

The Agency emphasises the importance of pre-submission meetings, around seven months prior to the anticipated date of submission of the application.

These are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the Agency.

These questions and answers and successful pre-submission meetings should enable applicants to submit applications that conform with regulatory requirements and can be validated speedily.

Pre-submission meetings also enable applicants to establish contact with the Agency staff who will be involved with the application.

To request a pre-submission meeting:

If an issue is not resolved by the Q&As below, please write to vet.applications@ema.europa.eu.

1. Early considerations and steps prior to submission

2. Preparing the dossier

2.1 Product name, product information, and prescription status

2.2 Quality

2.3 Compliance, environmental risk assessment and pharmacovigilance

3. Submission, validation and fees

4. Assessment of the application

4.1 Procedure

4.2 Inspections

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