EMA updated their product information templates for all medicines for human use
Thread poster: Siegfried Armbruster

Siegfried Armbruster  Identity Verified
Germany
Local time: 04:47
Member (2004)
English to German
+ ...
Jun 11, 2015

EMA updated their product information templates for all medicines for human use, for more info, please see: http://bit.ly/1e3hxDc


If you are interested in how to use the templates, there are some videos available:

In English:
Medical Translation 102: EMA templates and terminology
https://alexandria-translation-resources.com/product/video-ema-templates-and-terminology/

In German:
Fortbildung für medizinische Übersetzer 2: EMA Vorlagen
https://alexandria-translation-resources.com/product/video-ema-vorlagen/

Fortbildung für medizinische Übersetzer 5: Gebrauchs- und Fachinformation
https://alexandria-translation-resources.com/product/medizinische-ubersetzer-pils-und-smpc/


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xxxPLR TRADUZIO  Identity Verified
Italy
Local time: 04:47
English to French
+ ...
I'm not sure about.... Jun 11, 2015

QRD v 9.1 is still valid

EMA says:

Implementation timelines
It is recommended to implement the revised QRD template v9.1 as soon as possible, but not later than 2 years following the publication date, for medicinal products with regulatory activity, and no later than 3 years for medicinal products with no regulatory activity.

So, v9.1 WILL BE revides/modified within 2-3 years, but for the moment, there are no new PI templates.

Did I missed something ?


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Siegfried Armbruster  Identity Verified
Germany
Local time: 04:47
Member (2004)
English to German
+ ...
TOPIC STARTER
The update from version 9.0 to version 9.1 was yesterday Jun 11, 2015

PLR TRADUZIONI wrote:

QRD v 9.1 is still valid

Did I missed something ?


The latest update was yesterday - 10/06/2015 -

Quote EMA Latest update: June 2015 (version 9.1) (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59)

Addition of guidance on the acceptance of combined summaries of product characteristics (SmPCs) for different strengths of the same pharmaceutical form.
Revision of guidance on the dates to be recorded in section 9 of the SmPC (i.e. date of first authorisation and date of latest renewal).
Revision of guidance and new standard statements in Annex II.
New guidance for the inclusion of quick response (QR) codes on the labelling and package leaflet.
Revision of guidance on the list of local representatives in the package leaflet as a result of the revised European Commission (EC) Guideline on the packaging information of medicinal products for human use (i.e. no need to have the whole list of local representatives in the actual printed package leaflet).
Improvements in most language versions.
Any further changes affecting some or all of the linguistic versions of the templates will be published on this page.


[Edited at 2015-06-11 14:30 GMT]

[Edited at 2015-06-11 14:30 GMT]


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EMA updated their product information templates for all medicines for human use

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