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.
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.
The popularity of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) is rapidly rising, with an estimated one in four medical devices now relying on software. For manufacturers aiming to penetrate the European Union (EU) market, translating the graphical user interface (GUI) of their medical device software is essential for ensuring regulatory compliance as well as user engagement across the diverse linguistic landscape of Europe. Building on our previous discussion on the EU MDR language requirements for GUIs, this article explores the practical aspects of translating GUIs of software applications made available to users across...
Pal International, a global leader in infection control products, and Mastermind Translations, a specialised language service provider for life science industries, are pleased to announce their strategic partnership aimed at supporting Pal International’s presence in over 50 overseas markets.
As innovative technologies continue to revolutionise healthcare, software has become an indispensable part of many solutions, with as many as one in four medical devices now relying on it. Whether it is software in a medical device (SiMD) or software as a medical device (SaMD), the incorporation of a user-friendly graphical user interface is essential for enhancing usability and functionality. Against this meteoric rise in highly digitised medtech products, the need for clear and precise guidelines on translation for software applications is evident. However, the European regulatory framework for medical devices currently has no separate legal provisions regulating this aspect of medical...
In today’s world, where diversity is celebrated and global connectivity is at its peak, translating your website is a strategic necessity that can propel your life science organization towards remarkable international success. In this article, we delve deep into the fusion of website translation and search engine optimization (SEO) to unveil the secrets of creating appealing and result-oriented multilingual content. Drawing on our own experience, we share a case study of a medtech article localized into multiple languages that has consistently stayed in the top search results.
On 17th January 2024, the European Commission released two tables summarising the language requirements for manufacturers of medical devices under the EU MDR and IVDR. These tables consolidate the national translation requirements for medical devices and in vitro diagnostic medical devices, respectively, across 31 European countries. In this article, we analyse the key aspects of this publication, its benefits and limitations, and provide insights for manufacturers aiming for compliance.
In the fast-paced world of digital marketing, multilingual search engine optimisation (SEO) has become a crucial weapon in the arsenal of successful marketing strategies for life science companies looking to expand their global reach. In today’s fiercely competitive digital environment, the translation of your life science website’s content serves as a potent catalyst to improve your online visibility, helping you better connect with your international audience. In this article, we explore the intricacies of multilingual SEO translation and localisation with a dedicated focus on the life sciences industry. From understanding the basics of SEO to the complexities of a multilingual...
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.
In the rapidly evolving landscape of medical devices, patient safety takes precedence. When issues that could potentially pose risks to users and patients arise with a medical device, manufacturers must take swift corrective action. One essential tool in this process is the Field Safety Notice, a communication mechanism used by manufacturers to inform users and customers about safety concerns regarding their products. In this article, we explore the concept of Field Safety Notices, and discuss the mandatory language requirements applicable to them under the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR). What are...
Latin America, with its vast population of over 650 million across 20 countries, presents a rapidly growing market for medical device companies. Factors such as population growth, enhanced healthcare accessibility, and an increase in chronic diseases have fuelled rising demand for medical technologies in the region. Recent improvements in the medical device regulatory framework further facilitate market entry for medtech companies with global ambitions. To successfully navigate the local regulatory environment, manufacturers must comply with language requirements, and ensure that specific information is provided in the requested languages, such as Spanish or Portuguese. In this article, we explore the language...
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...