Today pharmaceutical companies manufacture and distribute medicines all over the globe. Accurate medical translation is very important. Knowing the European Medicine Agency’s labeling standards can help prevent costly and harmful labeling mistakes. If you are not fully aware of the EMA medical labeling guidelines, then seeking help from a regulatory consultant specializing in EMA labeling standards would be most beneficial. Your professional medical translation company can likely make recommendations of whom to contact for proper advice.
EMA Verification to Ensure Accurate Medical Translation
Pharmaceutical manufacturers are required by law to follow a number of standards and pass tests by the National Food and Drug Authority to verify the readiness of the medicines for market distribution. One aspect of the testing process includes verification based on the European Medicines Agency’s (EMA) Quality Review of Documents templates, which come in several languages. The templates, according to medical translator and blogger Emma Goldsmith, contain the official text to use in each medicinal product’s content labels, the summary of product characteristics, and the info sheet inserted in the packaging. These templates also have guidelines on appropriate font, font size, and page layout.
If you have a certain medicine that is produced for European use, you will notice, for example, that its descriptive text is in English followed by several languages, including Spanish, German, Portuguese, Swedish, French, and Russian. Each translation will also have the requisite flag icons displayed for clarity.
There are also three appendices the EMA uses to help translate medical product data. They focus on 1) side effects, 2) references to pregnant or lactating women’s use, and 3) storage methods, which usually includes the common safety phrase “Keep Out of Reach of Children.”
It is most important to obtain the advice of your regulatory/compliance team or a qualified, outside regulatory consultant to advise regarding the necessary requirements, guidelines, and polices of the EMA. It is critical that the English product information undergo scrutiny by the EMA for full compliance before it is translated. This procedure may take several months. Once you have final and approved source files in compliance with the EMA, the next step is to contact your professional medical translation partner.
The danger of misused drugs or complications arising from medicines having improperly translated labels or product information is too serious to overlook. Medical translation services from companies, such as Excel Translations, can help ease the translation process for you as you develop new opportunities in more and more foreign markets. When your labels, inserts, and packaging are finalized and are judged EMA-compliant, your medical translation provider can then ensure your labeling translations are done right the first time.