Foreword:
Your translators claim to know:
QRD templates and appendices
EDQM standard terms
other EMA requirements (excipients guidelines, Compilation of QRD decisions, etc.)
So why are your package leaflet translations not quite the ticket?
Read on…
Over the years, the QRD product information templates both for centralised procedures and for MRP/DCP have undergone various changes. The latest update for CP was rolled out in March 2013.
Compared with the Summary of Product Characteristics (SmPC), the QRD template wording for package leaflets (PILs) has been subject to monumental changes.
- FACT: This causes serious problems when translating older documents.
Many translators claim to have knowledge of – or access to – the QRD templates. However, in many cases, this knowledge or access only extends to the current QRD templates.
- FACT: When translating older PILs, the latest QRD templates cannot logically be applied without changing their content. This engenders serious legal problems for sworn translations that require a faithful rendering of the source text.
For example…
The wording of a PIL drafted in 2006 will be according to the QRD template version of that time (version 7 of 08/2005 for CP or version 01/2006 for MRP/DCP). When translating this PIL into another EU language, the corresponding “older” QRD template must be used. Otherwise, you will not get a faithful translation.
At Mynnaf Translations, we logically translate PILs (and SmPCs) in context and according to the template version of the source text. In short, if the source text is e.g. according to version 7 of 08/2005, then so too will be the translation.
In this way, your translated texts will be still QRD-compliant (as per the original) and not some hybrid attempt that differs in content from the source text.
Of course, this requires our in-depth knowledge of the evolution of the QRD templates throughout the years. Mynnaf Translation has gained this knowledge only through having made this highly specific area into our speciality.
UPDATING OLDER PACKAGE LEAFLETS – A SEPARATE SERVICE
Mynnaf Translations can also update package leaflets upon request. However, please note that this is offered as a separate service.