Re: INFO: New EMA QRD Templates : Again !

[Guest guest]

Dear Listmates,

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 ?

Le 17/10/2011 21:18, cgtradmed a écrit :

> Dear Listmates, 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/do\

cument_listing_000134.jsp & murl=menus/regulations/regulations.jsp & mid=WC0b01ac058\

0022c59 & jsenabled=true

>

<http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/d\

ocument_listing_000134.jsp & murl=menus/regulations/regulations.jsp & mid=WC0b01ac05\

80022c59 & jsenabled=true>

>

> Hope that this time it will be for good

>

> Have a nice evening

>

>

>

>

[Guest guest]

Hello Helke,

I have checked the French PIL : They kept the " infirmiere " (nurse).

Nothing changed or added.

In fact, it seems to be " beaucoup de bruit pour rien " (a lot of fuss

about nothing) !

Le 18/10/2011 10:55, Helke Heino a écrit :

> Hello Cathrin,

>

> Same in German - no changes/additions in these headlines.

>

> The main thing in the revised German templates (Package Leaflet) is that

> they changed " Ihre Pflegekraft " ( " nurse " ) to " das medizinische

> Fachpersonal " .

>

> Regards

> Helke

> ***********************************************

> TETRADOC Technical Translation + Documentation

> Helke Heino, Dip. Trans. (IoL), ADÜ Nord, tekom

> Übersetzungen EN -> DE: Medizin, IT, Wirtschaft

> mailto:helke.heino@...

>

>

> -----Ursprüngliche Nachricht-----

> 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.

>

>

>

>

>

> ------------------------------------

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