Linguistic Review of QRD Product Information Translations for Veterinary Medicines Receiving EU Marketing Authorisation via the EMA Centralised Procedure
12 December, 2024
Securing a European Union Marketing Authorisation for a veterinary medicinal product is a highly regulated process, designed to ensure that animal medicines meet rigorous standards of safety, efficacy, and quality. Introduced in 2022, the Centralised Procedure simplifies this process, enabling pharmaceutical companies to obtain approval across the European Economic Area with a single application. A fundamental, yet often neglected, aspect of this process is the Linguistic Review of Product Information translations coordinated by the European Medicines Agency. This article explores the key stages of reviewing and approving Product Information in 24 European languages for centrally authorised veterinary medicinal products, offering...Read more
Securing a European Union Marketing Authorisation for a veterinary medicinal product is a highly regulated process, designed to ensure that animal medicines meet rigorous standards of safety, efficacy, and quality. Introduced in 2022, the Centralised Procedure simplifies this process, enabling pharmaceutical companies to obtain approval across the European Economic Area with a single application. A fundamental, yet often neglected, aspect of this process is the Linguistic Review of Product Information translations coordinated by the European Medicines Agency. This article explores the key stages of reviewing and approving Product Information in 24 European languages for centrally authorised veterinary medicinal products, offering...Read more
The import and distribution of pharmaceuticals within the European Union (EU) are governed by a stringent regulatory system designed to ensure that patients across the EU have access to high-quality, effective, and safe medicines. Within this framework, before any medicinal product can be placed on the EU market, it must undergo a rigorous authorisation procedure. A critical yet often overlooked component of this procedure is the Linguistic Review of Product Information translations. This article explores the key steps involved in this process for pharmaceuticals for human use, authorised for the European Single Market via the Centralised Procedure.
The European Medicines Agency has updated its veterinary product information template to support the implementation of the new Veterinary Medicinal Products Regulation which became applicable on 28th January 2022. In this article, we discuss what changes have been made, what triggered them, and what they mean for applicants and marketing authorisation holders of veterinary medicinal products.