Linguistic Review Process of Product Information Translations for Medicinal Products Receiving EU Marketing Authorisation via the EMA Centralised Procedure
19 November, 2024
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 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.