QRD Templates into European Portuguese
One of the most popular requests is the translation and updating of Summary of Product Characteristics (SPCs), Patient Information Leaflets (PILs) and product labels. These documents are crucial for pharmaceutical companies to market their medicinal products in EU countries, and their preparation and translation happens according to strict guidelines.
The European Medicines Agency (EMA) is the official body regulating how these documents are written and translated. 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 a 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 the official EU languages plus Norwegian and Icelandic) and they must be followed individually in each country for a successful approval.
This template QRD template v10.3 has been revised in September 2022 solely* to include guidance in Annex II section C for conditional marketing authorisations.
Any new marketing authorisation granted via the centralised procedure as a conditional marketing authorisation must comply with the revised QRD template v10.3. Ongoing marketing authorisation applications must align their product information to the revised QRD template v10.3 as early as possible, and by Day 181 of the procedure at the latest
And this is where having a reliable and expert translation partner comes in handy. A language translation service provider like me that have years of experience with pharmaceutical translations knows exactly what to do and can ensure that every document in European Portuguese 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 my target language.
I work with a professional Portuguese native speaker editor specialised in pharmaceutical translation projects who is also more than familiar with the EMA centralised process and is also aware of our own country’s requirements. Finally, we 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 we can help you with a full translation or updates of your SPCs, PILs and labels following the current Portugal-specific QRD templates, get in touch with us by emailing to jgomes@joseamg.com.
