Pre-authorisation guidance under the Veterinary Medicinal Products Regulation

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) will change existing rules on the authorisation of veterinary medicines in the European Union (EU) when it becomes applicable on 28 January 2022.

Pre-authorisaton procedural guidance applicable under the Veterinary Medicinal Products Regulation is available to help pharmecutical companies prepare for submitting marketing authorisation applications for veterinary medicines after 28 January 2022. 

These questions and answers (Q&As) provide an overview of EMA's advice on issues that are typically addressed in discussions or meetings with marketing authorisation applicants before submitting an application.

EMA is publishing pre-authorisation procedural guidance applicable under the Veterinary Medicinal Products Regulation incrementally during 2021.

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

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

Guidance in this area is expected to be available from the fourth quarter of 2021.

2.2 Quality

2.3 Compliance, environmental risk assessment and pharmacovigilance

3. Submission, validation and fees

Guidance in this area is expected to be available from the fourth quarter of 2021.

4. Assessment of the application

4.1 Procedure

Guidance in this area is expected to be available from the fourth quarter of 2021.

4.2 Inspections

Guidance in this area is expected to be available from the fourth quarter of 2021.

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