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.
Medical device manufacturers who make their products available to users in EU Members States must meet stringent language requirements set out by the European Union Medical Devices Regulation (EU MDR) for the information supplied with their device. In this article, we break down the critical aspects of those translation requirements for labels and discuss effective practices for ensuring compliance, patient safety, and market success.
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Are you a medical device company preparing to place your products on the European market? The new European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) introduce language translation requirements that might leave you bewildered, especially if you are new to the EU market. Navigating the intricacies of these new regulations and finding definitive answers to your questions, often very specific to your unique circumstances, can quickly become a challenging and time-consuming task for you and your regulatory team. The absence of clear guidance can lead to frustrating searches, yielding ambiguous results open to interpretation.
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In today’s health-conscious society, the popularity of food supplements has soared. To protect consumers, preserve brand reputation, and avoid legal pitfalls, manufacturers and marketers must comply with labelling and promotional regulations. Getting your copy right from the start is also vital, to prevent misleading information being reproduced in translation. In this article, you will learn how to ensure regulatory compliance for your product information and its promotional material.
Montenegro’s progress towards full membership of the European Union has led to the harmonisation of many of its laws with EU legislation, including medical device legislation. The marketing of medical devices is subject to particularly stringent regulatory measures in the EU market, which has recently seen the introduction of new mandatory language requirements for product information, such as labels and instructions for use. This article aims to provide insights into the language requirements for medical devices in Montenegro and their implications for medical device companies intending to enter the Montenegrin market.
Serbia is making significant progress towards membership of the European Union and, as part of this process, has harmonised a number of its laws and regulations with EU legislation. One such legal area concerns the marketing of medical devices. This is subject to stringent regulatory measures, including mandatory language requirements for the product information accompanying the medical device, such as the label and instructions for use. As a result, manufacturers of medical devices intending to place their products on the Serbian market must follow strict language rules. This article will explore the language requirements for medical devices in Serbia and...
Nearly 80% of medical devices in Turkey are imported, with as many as half of those imports coming from the European region. While still a candidate for EU membership, Turkey has developed a strong trading relationship with the EU spanning nearly three decades, in order to facilitate the movement of medical technologies into its market. This relationship relies heavily on the alignment of Turkish medical device legislation with that of the EU. The scope of this harmonisation also covers the language requirements for medical devices in Turkey. In this article, we discuss the linguistic rules for manufacturers and importers of...
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En qualité de fabricant, avant la mise sur le marché européen de votre dispositif médical, vous devez d’abord démontrer que votre produit est conforme à la législation européenne en vigueur. La déclaration de conformité UE est un document incontournable de ce processus réglementaire. Selon l’État membre où votre dispositif médical sera mis à disposition, la déclaration de conformité devra être traduite dans la ou les langues officielles du pays en question. Dans cet article, nous examinons les exigences linguistiques imposées dans les textes réglementaires s’appliquant aux dispositifs médicaux (DM) et aux dispositifs médicaux de diagnostic in vitro (DMDIV) s’agissant de la...
Le nouveau règlement européen relatif aux dispositifs médicaux (RDM) resserre les contraintes entourant la commercialisation des dispositifs médicaux sur le marché européen. Il exige en effet que chaque État membre de l’Union européenne définisse la ou les langues dans lesquelles un dispositif est mis à disposition. Dans cet article, nous présentons les langues acceptées dans chaque État membre conformément aux exigences linguistiques du RDM.
The value of in vitro diagnostic medical devices resides in the quality of diagnostic data they provide. The EU IVDR 2017/746 states very clearly that an in vitro diagnostic medical device must be supplied with information in an official EU language(s) chosen by the Member State in which it is made available to the user or patient. However, it is less clear whether these translation rules also apply to text appearing on the device’s screen and in software that is a device in itself. In this article, we revisit the linguistic provisions under the IVDR, and focus specifically on the...
Bevor Sie ein Medizinprodukt in der EU in den Verkehr bringen können, müssen Sie als Hersteller zunächst nachweisen, dass Ihr Produkt der geltenden EU-Gesetzgebung entspricht. Die EU-Konformitätserklärung ist dabei ein zentrales Dokument. Je nach EU-Mitgliedstaat, in dem Sie Ihr Medizinprodukt einführen möchten, muss Ihre EU-Konformitätserklärung möglicherweise in die Amtssprache(n) des jeweiligen Landes übersetzt werden. In diesem Artikel möchten wir Sie über die Anforderungen an die Sprachen für die EU-Konformitätserklärung informieren, die von den Verordnungen für Medizinprodukte und In-vitro-Diagnostika der EU (MDR und IVDR) gestellt werden. Ganz konkret gehen wir auch auf die Sprachen ein, die in den einzelnen EU-Mitgliedstaaten akzeptiert...
Before placing your medical device on the EU market, as the manufacturer you must first demonstrate that your product complies with the applicable EU legislation. The EU declaration of conformity is an essential document in this regulatory process. Depending on the EU Member State where your medical device will be made available, the EU declaration of conformity may also need translating into the country’s national language(s). In this article, we will discuss the EU MDR/IVDR language requirement for the declaration of conformity. You will also learn which language versions of it individual EU Member States accept.