EMA templates - how to follow them?!
Thread poster: Dr. Bettina Meissner

Dr. Bettina Meissner
Germany
Local time: 12:15
Member (2011)
English to German
+ ...
Oct 19, 2011

Hi,

I apologize in advance, if this has already been discussed elsewhere in this forum.

The translation agency I work for has recently "complained", as I had added context to the source text of a leaflet, although I was actually trying to follow the latest EMA templateicon_smile.gif.

The PM told me that the EMA template is only a guideline for titles and terminology.

Example:

The latest English template says:

"If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your for advice before taking this medicine.>"

The way I understand it, you can choose from the terms given in brackets (like doctor or pharmacist or both), but the rest of the text should be followed.

In my translation, I therefore added "or breast-feeding" (as it was not an option given in brackets), although that was not written in the source text.

Or: The template is giving the headline "Children and adolescents", but my source text says "Children and adolescents under 18 years" - should I translate "under 18 years" or stick to the template?

I'd really apprecciate your help or constructive comments!icon_smile.gif


 

Emma Goldsmith  Identity Verified
Spain
Local time: 12:15
Member (2010)
Spanish to English
EMA templates Oct 19, 2011

Interesting question, Bettina.

In my opinion, EMA templates should be followed by the pharmaceutical companies when they present their marketing authorisation application dossier.
Applicants should use the translations on the EMA website.

However, I don't think it is our job as translators to amend our source text to match the templates. Maybe you could add a note to say that the template says "pregnant or breast-feeding".

These translations often have a back-translation process, so any deviations from the official translation should be picked up at that stage.


 

Siegfried Armbruster  Identity Verified
Germany
Local time: 12:15
Member (2004)
English to German
+ ...
Your PM might be wrong Oct 19, 2011

e. g. see "QRD convention to be followed for the EMA-QRD templates"

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500005091.pdf

Everything depends on the job instructions. For these jobs I normally get/issue the instruction:

"Please follow the QRD templates for a "specific procedure", Please adapt the translation if necessary and include a comment if you do so"

Another set of instructions could be: "Please don't follow the QRD templates and stick to the wording in the source text."

This makes it clear for the translator what is expected.

The EMA actually does not make the use of the templates mandatory, see:
GUIDELINE ON THE PACKAGING INFORMATION OF MEDICINAL PRODUCTS FOR HUMAN USE AUTHORISED BY THE COMMUNITY

Which says:

The text of the leaflet
The Community authorisation of a medicinal product includes the text of the leaflet,
which is the same throughout the Community.
In accordance with Article 63(2) of Directive 2001/83/EC as amended, the package leaflet
must be written in clear and understandable terms for the patient and be clearly legible.
Applicants should refer in this respect to the guideline on the readability of the label and
package leaflet of medicinal products for human use. In particular, applicants should
consider using the "model leaflet" annexed to that guideline. Product information
templates and various reference documents prepared by the Quality Review of Documents
group and published by the EMEA on the EMEA Website, should also be taken into
account.



[Edited at 2011-10-19 09:20 GMT]


 

Catherine GUILLIAUMET  Identity Verified
Local time: 12:15
English to French
+ ...
50/50 Oct 19, 2011

Bettina Meissner wrote:

Hi,

I apologize in advance, if this has already been discussed elsewhere in this forum.

The translation agency I work for has recently "complained", as I had added context to the source text of a leaflet, although I was actually trying to follow the latest EMA templateicon_smile.gif.

The PM told me that the EMA template is only a guideline for titles and terminology.

Example:

The latest English template says:

"If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your for advice before taking this medicine.>"

The way I understand it, you can choose from the terms given in brackets (like doctor or pharmacist or both), but the rest of the text should be followed.

In my translation, I therefore added "or breast-feeding" (as it was not an option given in brackets), although that was not written in the source text.

Or: The template is giving the headline "Children and adolescents", but my source text says "Children and adolescents under 18 years" - should I translate "under 18 years" or stick to the template?

I'd really apprecciate your help or constructive comments!icon_smile.gif



Hi, Bettina.

First of all your PM is wrong, and Siegfried is right.

But, for the first one :
"If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your for advice before taking this medicine.>"

The way I understand it, you can choose from the terms given in brackets (like doctor or pharmacist or both), but the rest of the text should be followed.

In my translation, I therefore added "or breast-feeding" (as it was not an option given in brackets), although that was not written in the source text.


Here, it depends on the bioavailability of the drug, and it may not pass into the milk, as demonstrated in the pre-clinical studies, so you cannot "invent" the breast-feeding part,

For the second one :
Children and adolescents - you must comply with the template.

In fact, it often happens that I draw the client's attention on every sentence or section not complying with the latest templates (of course, if we are speaking of a new drug) and suggest the good new version, as a comment to the text.

I know, this is not easy, but a part of our job is also to highlight the problems, with diplomacyicon_smile.gif

Have a nice day

Catherine


Most of the time, my clients - agencies included - do insist on the compliance of the translation with the latest versions of the EMA QRD templates.


 

Dr. Bettina Meissner
Germany
Local time: 12:15
Member (2011)
English to German
+ ...
TOPIC STARTER
@Emma, Siegfried and Catherine Oct 19, 2011

Thank you for your comments - I'm feeling a bit rehabilitated!icon_smile.gif

In my case, the client indeed sent the German EMA template to be followed, so that's why - of course - I noticed all these little discrepancies and mostly decided in favour of the template. My PM then asked me to make amendments, so that the source text was matched.

As for the "breast-feeding" - in my case, the medication was excreted into the mother's milk, which encouraged me to add "and breast-feeding". I guess that - even if the drug is not excreted into the milk - the sentence should be ok, as it only says "ask your doctor, if...". The doctor can still say "no problem, the drug is not excreted...".

I agree that it's probably best to highlight the discrepancies (as suggested by Catherine), so the client can decide.

Also agree with Emma, that the pharma company should actually prepare the leaflet in line with the latest template...


 

Anna Spanoudaki-Thurm  Identity Verified
Germany
Local time: 12:15
Member (2009)
German to Greek
+ ...
never add or omit information Oct 19, 2011

Bettina Meissner wrote:
As for the "breast-feeding" - in my case, the medication was excreted into the mother's milk, which encouraged me to add "and breast-feeding". I guess that - even if the drug is not excreted into the milk - the sentence should be ok, as it only says "ask your doctor, if...". The doctor can still say "no problem, the drug is not excreted...".


The EMA templates may change twice or three times during the time between the preparation of the original of a leaflet and the approval of the translations. This is one reason there are discrepancies between the original that we receive and the templates. Another reason may be that in a particular case the template cannot/should not be applied (like in the - relatively harmless - example of a medicine not excreted in the milk).

I would never add or omit information in order to adhere to the template unless I have specific instructions to do so. The final responsibility for the context remains with the client and they have the necessary knowledge to decide what should be included or omitted. My responsibility is to translate faithfully, especially when the text is as sensitive as a drug leaflet. I follow the template wording only if the original also does (or is very close) and inform the client when it does not. I usually include a "The original does not always follow the latest template" in an e-mail and do not comment each and every incidence of discrepancies.


 

Emma Goldsmith  Identity Verified
Spain
Local time: 12:15
Member (2010)
Spanish to English
A Translator's Guide to the EMA Templates May 26, 2012

The question of whether translators should stick to the source text or to the template is a continual source of debate. A (somewhat simpler) problem that new translators have is where to find the template and what to do with it when they find it.

Last week an agency asked me to write some basic instructions for its medical translators about how to use the EMA templates. They said I could publish the mini guide in my new blog, "Signs & Symptoms of Translation", so I thought I would leave a link here for anyone who stumbles across this post in the future:

A Translator’s Guide to the EMA Templates.


 

Dr. Bettina Meissner
Germany
Local time: 12:15
Member (2011)
English to German
+ ...
TOPIC STARTER
@Emma May 26, 2012

Thank you Emma, this is indeed very useful!

 

Emma Goldsmith  Identity Verified
Spain
Local time: 12:15
Member (2010)
Spanish to English
EMA template webinar May 16, 2014

I'm just reviving this thread to mention that I'm giving a webinar next week (Wednesday, 21st May 2014) about EMA templates.

I'll be discussing:
- where to download the templates and how to use with them
- how EMA guidance documents can help translators
- what to do when the source text doesn't match the template (as mentioned in this thread)
- how to flag forbidden terms
- how to translate updates to existing documents with track changes in source and target files
- where to access free and subscription versions of MedDRA terminology

For more details please read my blog post here:
http://signsandsymptomsoftranslation.com/2014/05/14/ema_templates/

And sign up for the webinar at the Alexandria Project here:
http://alexandria-translation-resources.com/product/medical-translation-102-ema-templates/

See you there!


 


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