One of the most popular requests for our Commercial Department is the translation and updating of Summary of Product Characteristics (SPCs for short), Patient Information Leaflets (PILs) and product labels. These three documents are essential for pharmaceutical companies to market their medicinal products in EU countries, and their preparation and translation happens according to strict guidelines.
The official body regulating how these documents are written and translated is the European Medicines Agency (EMA). Any pharmaceutical company that wants to market their products in any EU member state must submit a marketing authorisation application through a centralised procedure. As part of this procedure, the company needs to prepare the product’s SPC, PIL and label in compliance with the so-called Quality Review of Documents (QRD) template which contains the approved headings and dictates what needs to be included in these documents in every member state. This template is available in 24 languages (the official EU languages plus Norwegian and Icelandic) and they must be followed individually in each country for a successful approval.
From time to time this template is updated, and the latest version of the QRD template – v10.1 – has just recently been published. What this means is that pharmaceutical companies need to make sure that their existing documentation meets the new requirements set out in v10.1 of the template and that their new applications also follow this latest version. Also, with this update, a new type of document – Annex II – has been added to the list of required documents in every language.
And this is where having a reliable and expert translation partner comes in handy. A language service provider like First EditionTranslations that has years of experience with pharmaceutical translations knows exactly what to do and can ensure that every document in all the 24 languages complies with the specifications. QRD template updates can be a tricky business as each and every language may have country-specific changes, so it’s not just a case of translating the changes in the English template into the target languages.
At First Edition we work with professional mother-tongue translators specialised in pharmaceutical projects who are more than familiar with the EMA centralised process and are aware of their own country’s requirements. Our in-house Project Managers at our Commercial Department carry out strict quality assurance checks to ensure that the final, updated version going back to our clients meets the specifications as we know how important accuracy and compliance is for these projects.
If you have any questions about how First Edition can help you with a full translation or updates of your SPCs, PILs and labels following the current country-specific QRD templates, get in touch with our Commercial Department by emailing firstname.lastname@example.org or giving our team a call at 01223 356 733.