New EMA QRD templates : Again !
Thread poster: Catherine GUILLIAUMET

Catherine GUILLIAUMET  Identity Verified
Local time: 20:21
English to French
+ ...
Oct 17, 2011

Good evening,

Well, EMA still working hard.

Now, they have issued new modified multilingual templates (again) :

The last issues are downloadable at :
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580022c59&jsenabled=true

Hope that this time it will be for good

Have a nice evening
Catherine


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Emma Goldsmith  Identity Verified
Spain
Local time: 20:21
Member (2010)
Spanish to English
Thanks Catherine Oct 17, 2011

I shall update my references yet again!

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Catherine GUILLIAUMET  Identity Verified
Local time: 20:21
English to French
+ ...
TOPIC STARTER
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 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]


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Emma Goldsmith  Identity Verified
Spain
Local time: 20:21
Member (2010)
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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Catherine GUILLIAUMET  Identity Verified
Local time: 20:21
English to French
+ ...
TOPIC STARTER
Good idea! Oct 18, 2011

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


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Emma Goldsmith  Identity Verified
Spain
Local time: 20:21
Member (2010)
Spanish to English
update Oct 20, 2011

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.


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Catherine GUILLIAUMET  Identity Verified
Local time: 20:21
English to French
+ ...
TOPIC STARTER
Merci, Emma ! Oct 20, 2011



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