A translator’s guide to the EMA templates

Last week an agency asked me if I would write some instructions for their medical translators about using EMA-QRD templates in their work. I thought I would share my ideas with you. First, let me clarify that I’m talking about the European Medicines Agency. The acronym EMA has been widely used, unofficially, since EMEA dropped the second E in its name two years ago (‘Evaluation’ was removed from its full title). Also, it tended to be confused with Europe, Middle East and Africa. Anyway, I’m all for using EMA, being true to my name! QRD stands for Quality Review of Documents, which is a working group associated with the Committee for Medicinal Products for Human Use (CHMP) and other EMA scientific committees. The QRD templates on the EMA website give you the official wording that has to be used in the summary of product characteristics (SmPC), labelling (L) and package leaflet (PL) of medicinal products, in accordance with Directive 2001/83/EC. The aim is to ensure consistency across different medicinal products and across all Member States. The templates define:

  • Standard headings (e.g. “CLINICAL PARTICULARS”)
  • Standard statements and terms (e.g. “Keep this medicine out of the sight and reach of children”).
  • The format and layout to be used (e.g. Times New Roman, 11 pt)

You can find the main template for the SmPC, L and PL at Product information: Regulatory and procedural guidance. Scroll down the page until you come to the QRD templates: QRD templates

The main template is in DOC format. It’s a good idea to download versions in your source and target languages from the drop-down list, because then you can check that your source text complies with the template. If it differs, you need to go back to your client to ask whether you should follow the source text faithfully or keep to the template. The appendices contain standard statements and terms for specific sections:

  • APPENDIX I – Pregnancy and Lactation statements for the SmPC.
  • APPENDIX II – Undesirable effects. This appendix uses the MedDRA frequency convention and system organ class database. The drop-down menu is bilingual and each file is in English plus the selected language. Use the file to create your own mini-Translation Memory or Term Base.
  • APPENDIX III – Storage statements for the SmPC, L and PL.
  • (Also, check out Appendix IV if you’re not sure how to translate “batch” and “expiry date” in your target language.)

Some of these documents make use of Word’s track changes to highlight the latest updates in these versions. Now scroll further down the same page until you reach the QRD Guidance section: QRD guidance There are three (English-only) documents that are particularly relevant for translators. I’ve circled them in the screenshot above.

1.    QRD convention. This short PDF gives specifications regarding font, font size, page layout, etc. Check that your source document follows these specifications and if it doesn’t, I would recommend adapting your translation to these requirements. (Again, you may want to check this with your client). It also explains the bracketing convention, although of course you shouldn’t find any of these brackets in the final text.

  • {} = Information to be filled in
  • <> = Text to be added or deleted
  • [Green text] = Guidance and explanatory notes only.

2.    QRD decisions on stylistic matters. This is a tabulated list of linguistic problems that have been identified and solved. It covers the use of abbreviations, gender issues, number formats, spaces between figures and units, etc.

3.    QRD decisions on use of terms. This is a short list of terminology problems, prohibited terms and controversial terms. Check out this file if you’re not sure whether to use excipients or ingredients; posology or dose; newborns or infants. The EMA has also just published new versions of the controlled vocabularies used in Extended EudraVigilance product report messages. Use these Excel files when translating documents based on QRD templates if you need to confirm the standard terms for units of measurement, pharmaceutical dose forms, substances, etc.

To summarise, when you are asked to translate an SmPC, L or PL using the EMA-QRD templates:

  1. Download the main template in your languages (I keep them on my second monitor when I’m translating). Check out the appendices.
  2. Read the QRD guidance documents on formatting, style and terminology.
  3. Use the standard headings, statements and terms in the template and the appendices.

Edited to add: This is the basics of how to use EMA templates. If you’d like more up to date and detailed information on this subject, I recommend two videos I recorded for eCPD Webinars in September 2016:

Image attribution: raymaclean
 

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29 Responses to A translator’s guide to the EMA templates

  1. Excellent, EMmA 🙂

    Bravo !
    Very useful advices for newcomers to EMA.
    Catherine

  2. sdeschmidt says:

    Noticed your topic on ProZ – wow – thanks a million, very useful!
    Sibylle

  3. Vanessa Martínez says:

    Excellent post!
    Vanessa

  4. Shirley Lao says:

    Thanks for sharing!

    Shirley

  5. Alicia says:

    Great article, Emma! I hope you don’t mind I share the link to you article in our social networks.

    • Thanks, Alicia. Yes, please feel free to link to the article. I’m glad you think it’s interesting. Thanks Shirley, Vanessa, Sibylle and Catherine for your comments too!

  6. Cindy Coan says:

    I join in the thanks for the info. Although I’ve had some experience in Spanish > English medical translation, much of what you have to say on the subject of EMA was new to me.

    • Hi Cindy, It’s great you learnt some new things about EMA. If you want to learn more, you may be interested to read the next post called ADRs: a new EMA website and a terminology review. Enjoy!

  7. Iris says:

    Hi Emma,

    Great blog! I am taking the liberty to sharing it among translators in our network. I hope you don’t mind

  8. Great post, Emma! Very useful! Thanks a lot!

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  10. Thomas Tolnai says:

    Hi Emma,

    It took me some time to stumble upon your post, but it is very useful. I began translating SmPCs a couple of years back and have recently focused on this niche. Maybe we can stay connected and share knowledge and ideas on this topic? 🙂
    Thanks!

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  13. C says:

    mmm, the brackets issue is a bit more complex IMHO

    indeed, the “Practical information on translations for referral procedures (human)” says:
    Make sure that the title page is adjusted in accordance with the adopted English text and that allthe brackets (i.e ) are taken out in the title.
    but it’s about TITLES, not exactly any area of a QRD!

    the “QRD convention to be followed for the EMA-QRD templates” says only:
    {text} = Information to be filled in, i.e. normal text.
    Text to be selected or deleted as appropriate
    but without some examples the matter is not very clear as well!

    furthermore, note that you can find sentences as:

    where removing all brackets, i.e. even the brace ones, can cause confusion

    or sentences as:
    Healthcare professionals are asked to report any suspected adverse reactions via .
    where removing all brackets cause an awful Italian wording

    so I think that removing all triangular brackets is always safe, but I still have some doubt on removing brace and square brackets

    I’ll try to contact some EMA officer, and I’ll let you know the answer, if any

    • BTW, I’m Claudio Porcellana

      • Hi Claudio,
        Thanks for your comment. I never actually see these brackets in my source files, as they should be removed by the medical writer who writes the original document. Maybe it doesn’t work like that when you translate out of English?
        Re: your other comment on controlled vocabularies, I agree they aren’t much use in their monolingual list format. I just mentioned them because they were fairly new when I wrote this post. The EDQM Standard Terms database is far more useful, as I’m sure you know!
        Emma

        • claudioporcellana says:

          I never actually see these brackets in my source files, as they should be removed by the medical writer who writes the original document.

          you are lucky, as indeed, I see them in any case, so I have always to think how to manage them
          here you find the answer by the Austrian EMA officer:
          “the point with square brackets is that they have to be removed and/or replaced anyway!
          The phrase [to be completed nationally] never should appear in the finished texts. Instead it has to be completed nationally.
          Take your example with the reporting of adverse reactions, let’s imagine this should be done for Austria, the finished sentence should read:
          Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
          Österreich
          Bundesamt für Sicherheit im Gesundheitswesen
          Inst. Pharmakovigilanz
          Traisengasse 5
          AT-1200 WIEN
          Fax: + 43 (0) 50 555 36207
          Website: http://www.basg.gv.at/

          So instead of [to be completed nationally] the actual details of our reporting system have been inserted.

          Whereas for Estonia for example the sentence would read as follows:
          Healthcare professionals are asked to report any suspected adverse reactions via http://www.ravimiamet.ee

          Regarding your other example:

          This is used for lists. Like for example in the PL the names of a medicinal product, authorised in more than one member state have to be listed under the following heading:

          – If the product is authorised only in one member state, this heading can be deleted. If it is authorised in other member states, too but with a different name the list has to be filled in with the different names and the name of the corresponding member state

          You can also probably find some help in the so-called “annotated template” where some more explanations are included:
          http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/10/WC500004368.pdf

          then I asked her:
          “now, I still have the doubt that this “internationalized text” is not to be put during (my) translation, but later in a next step of EMA procedure, may be by the drug company that managed to have the translation in all languages, so can you still confirm that is a duty of the first translator/reviser place the localized informations?

          and the answer was:
          this is in fact a good question.
          As the actual details (complete contact data and addresses from Appendix V, the file I think you have seen) of the national reporting system(s) will only have to be included for the printed materials, I don’t think that this is a duty of the first translator/reviser.
          The QRD templates (also the ones translated in the different languages) contain only the wording for the electronic version of SmPC, PL and LAB with a hyperlink to Appendix V. And I think this is the version a translator/reviser is working with.
          But filling in the actual details of the national reporting system is in fact not a work of “translation”. At least in my opinion. This is more regulatory work I would say – finding out, which member state needs what version and when…
          But I admit it could be possible that some companies think different about it.

          As you mentioned referral texts, too, here is one more link that could be useful for you:
          http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/QRD/CMDh_201_2005_Rev7_2013_04-Clean.pdf

          This is again an annotated template but this time not from EMA but from CMD(h) and adapted/commented with regard to referrals, too.

  14. and too bad controlled vocabularies aren’t controlled dictionaries (bilingual or multlingual): indeed, one of them is multilingual but not indexable at all, i.e.not interesting to me

  15. claudioporcellana says:

    and another interesting question

    I found a couple of severe grammar mistakes in what I ever thought to be a MedDRA document, i.e. the “WC500004419 MedDRA frequency convention and system organ class database”
    but after an exchange of ideas with a MedDRA officer I found that:
    “This is an EMA document and is not something produced by the MSSO. The frequency information you are refering to are not MedDRA terms, so you will need to contact the EMA to make any corrections to this document. However, if you do see MedDRA terms that are not properly translated into Italian, then I will be happy to review these for potential correction.”
    and
    “The MSSO and the EMA are completely separate organizations. The MSSO is not responsible for content published by the EMA. The EMA is a subscriber to MedDRA”

    so, these mistakes were made by someone in EMA, that at least in Italy is not easy to contact, not mentioning to have mistakes fixed.

    But I know that the situation is not better elsewhere: a DE colleague issued a comment on the QRD template with more than 200 requests for change, and as far I know those problems are still there

    so, adding that many leaflets of drugs that are already in the market since years contains blunders, be aware that EMA documents /TAUS corpora for example) aren’t exactky The (translation) Bible …

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  17. Hi Emma!

    I have a little question about these templates. (I viewed your webinar on this as a recording and found it really helpful 🙂 ). I am working on an SmPC right now, using the most recent versions of the French and English QRD templates.
    When I compare some terms in these to the ‘Compilation of QRD decisions on use of terms’ document, there are quite a few differences. Two examples being ‘new born infant’ becoming ‘neonate’ and ‘adverse reactions’ becoming ‘undesirable effects’. As the English QRD template was updated in 2013, and the terms document in 2011, I am using the template terminology. I assume this is the right thing to do?

    And, this is a warning to anyone else not to rely too heavily on the terms document in their translations. 🙂

    Thanks in advance,

    Best, Jane

  18. Hi Jane,
    Very interesting point. I’d say that in the case of “undesirable effects”, the only place this is used is as the heading for point 4.8. Elsewhere, adverse reactions is used, which is consistent with the QRD decisions document.
    I do agree about the discrepancy between “newborn infant” and “neonate” because I understand they both refer to infants aged 0-27 days. “Newborn infant”, used in the QRD decisions, is also defined as such in CPMP/ICH/2711/99.
    I might write to the EMA to ask their opinion on this one. Are there any other terms you’d like to query at the same time?
    Emma

    • Hi Emma,

      Writing to EMA sounds like a good idea. I am working through this SmPC today, so by tomorrow I will know if I have any more terms to query.

      I am going to go ahead and use ‘neonate’ etc. in the meantime, as I have the most current QRD example to back me up. 🙂

      I’ll be in touch again soon,

      All the best, Jane

      • Hi Emma,

        I didn’t find any other discrepancies, and in the end I used ‘adverse reactions’ throughout. I wonder if they simply made a mistake in the heading, as it does seem strange to have a different term in the heading compared to what is used in the remainder of the document.

        Thanks,
        Jane

        • I’ve just received a reply from the EMA about these two queries.

          1. “Newborn infant”/”neonate”: we are aware of the discrepancy between the template and the compilation. The term “neonate” will be removed from the template at the next update as “newborn infant” is the correct term.
          2. Use of “undesirable effects”: “undesirable effects” is used as the heading for section 4.8 in the QRD template as this uses exactly the same headings as the SmPC Guideline.

          So, point 1 is nicely clarified and we can look forward to an updated template in due course, and point 2 skirts around the reason for using “undesirable effects” instead of “adverse reactions”.

          • Thanks Emma for clearing this up.

            Well, I had used ‘neonate’ for the translation I was working on at the time, for the reasons detailed above. I am not sure why they included that in a ‘template’, as to my mind a ‘template’ is an ideal which must be followed – the other reason I chose to use the term is because the template is two years more modern than the compilation. Obviously I work to a different variety of logic. 😉 And, from now on, I will use ‘newborn infant’. Point 2 is an obsfucatory answer if ever there was. 🙂

            Thanks again!

            Jane

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