If you were to eavesdrop on our conversations at the FE Commercial Department, you would often hear two mysterious acronyms: SPCs and PILs. Together with product labelling they are an integral part of our pharmaceutical translations. For the 12 years Ana has been with First Edition Translations, they have played a huge role in her work life, and over the years she has become an SPC expert. I have asked her to tell us a bit about these documents.
What exactly are SPCs, PILs and labels? Why are they so important?
An SPC is a summary of product characteristics and a PIL is a patient information leaflet and the label is what it says… well, on the label. The three of them together form the bulk of the documentation that pharmaceutical companies must provide to patients and healthcare professionals and they are what needs to be submitted for approval to the European Medicines Agency. Before marketing any medicinal product in EEA countries these documents must be submitted and approved by the EMA.
What does a project involving these types of documents usually look like?
It depends. There are two types of projects involving these documents, either a full translation or updates to existing translations. Often the updates are required into 24 European languages and are usually done within a strict deadline of a few days. And let me tell you, I sometimes receive several requests on the same day which means that hundreds of emails are sent back and forth and things can get quite hectic but exciting.
What is it that you need to pay attention to as a project manager? What does your in-house quality control consist of?
There are so many things! The most immediate concern is to place the request with the right translators. Not only mother-tongue, qualified translators, but also those who have experience with these types of projects, are aware of latest updates to templates as well as specific terminology. Then I make sure that everything is done, all the updates are correctly applied, both within the context of that particular project and that of the regulatory requirements issued by the EMA.
What advice would you have for our clients when placing a request for such a project?
Well, first of all, it’s very important the English files are prepared correctly, and are up-to-date with regulations and templates. In the case of updates, clear track changes are very welcome. For full translations, one thing that can get lost along the process is the invented name in the required languages. They should be submitted with the translation request. And the other thing is preparation and advance warning: the more time we have to work on these very important documents, the better the results.
If you have any questions or queries about SPCs, PILs and labels or would like to request a no-obligation quote, get in touch by email (email@example.com) or give us a ring on 01223 356 733.