The European Medicines Agency has just added a section called “How to prepare an SmPC” to its website. The aim of the new section is to help applicants include quality information in a clear and concise way when submitting a Summary of Product Characteristics. As translators, the section provides a useful new resource for enhancing our understanding of the SmPC, although unfortunately it’s only available in English.
An introductory 7-minute video is followed by a downloadable PowerPoint presentation with similar but more detailed information. Then there is a list of PDF files, one for each section in the SmPC. Each file gives specific examples for the point under discussion and there are FAQs at the end of the PDF. Tips on style and format are also offered, such as:
Safety warnings should be clear, compelling and effective. [Section 4.4.]
Unfortunately, the advice on clarity is not always followed in the PDFs themselves, and I had to read this long sentence a couple of times before I managed to grasp its meaning:
The conditions, in which the use of the medicinal product could be acceptable, provided that special conditions for use are fulfilled, in particular, specific risk minimisation measures requested as part of a risk management plan to ensure safe and effective use should be provided in section 4.4. [Section 4.6.]
In general, however, these new PDFs have a very appealing layout and are highly informative for healthcare professionals and medical translators. You can find more tips on translating SmPCs in my blog article on A Translator’s Guide to the EMA Templates.
Webinar on EMA templates
The EMA section on How to Prepare an SmPC ties in nicely with a webinar I’m presenting on 21 May 2014 through the Alexandria Project. I’ll be talking about EMA templates, other resources you need to translate SmPCs, and how to add this terminology to termbases and translation memories to speed up your work and ensure consistency. Book your place now!