New EMA QRD templates : Again ! Thread poster: Catherine GUILLIAUMET
| | Emma Goldsmith Spain Local time: 03:00 Member (2004) Spanish to English Thanks Catherine | Oct 17, 2011 |
I shall update my references yet again! | | | Revised or not revised ? | Oct 18, 2011 |
Good morning, I'd like to draw your attention on a strange point : Though EMA has updated the English version on Oct 12th, the French on-line versions have not been modified, whatever is the type of procedure concerned. For instance, in the "Quality Review of Documents human product-information template version 8 - highlighted", in the EN version (Rev. Oct 12) you can read this : "2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General de... See more Good morning, I'd like to draw your attention on a strange point : Though EMA has updated the English version on Oct 12th, the French on-line versions have not been modified, whatever is the type of procedure concerned. For instance, in the "Quality Review of Documents human product-information template version 8 - highlighted", in the EN version (Rev. Oct 12) you can read this : "2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description [For advanced therapy product only] 2.2 Qualitative and quantitative composition[For advanced therapy product only]" But, the French version - still dated 07/2011 - still reads : "2. COMPOSITION QUALITATIVE ET QUANTITATIVE 2.1 Description générale 2.2 Composition qualitative et quantitative" As you can see, there is neither modification nor addition. Do you notice the same thing for other languages ? Have a nice week, Catherine
[Edited at 2011-10-18 08:53 GMT] ▲ Collapse | | | Emma Goldsmith Spain Local time: 03:00 Member (2004) Spanish to English other errors too | Oct 18, 2011 |
Catherine GUILLIAUMET wrote: Do you notice the same thing for other languages ? Yes. Not only is this the case in the Spanish version (it is missing "For advanced therapy product only"), but also, under Pharmaceutical Form: "The score line is not intended for breaking the tablet" is translated as: "La ranura debe utilizarse para fraccionar el comprimido". (The negative has been omitted). The Spanish version is dated Versión 8, 07/2011 Rev. 1, 10/2011 I have just emailed EMA. | |
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Emma Goldsmith wrote: Yes. Not only is this the case in the Spanish version (it is missing "For advanced therapy product only"), but also, under Pharmaceutical Form: "The score line is not intended for breaking the tablet" is translated as: "La ranura debe utilizarse para fraccionar el comprimido". (The negative has been omitted). The Spanish version is dated Versión 8, 07/2011 Rev. 1, 10/2011 I have just emailed EMA. Excellent initiative, Emma. Maybe they will use professional translators/editors, next time Catherine | | | Emma Goldsmith Spain Local time: 03:00 Member (2004) Spanish to English
I have heard back from EMA. They were aware of the error in the Spanish version and it will be corrected in a few days. Re the "[For advanced therapy product only]" phrase. Apparently this is for guidance only and so it didn't have to be translated, although it was actually translated in some languages. | | | Merci, Emma ! | Oct 20, 2011 |
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