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  3. Medical: Pharmaceuticals

Zulassung (Arzneimittel)

English translation: marketing authorisation

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
German term or phrase:Zulassung (Arzneimittel; EU)
English translation:marketing authorisation
Entered by: Steffen Walter

12:54 Mar 19, 2017
German to English translations [PRO]
Law/Patents - Medical: Pharmaceuticals / Arzneimittel/EG-Recht
German term or phrase: Zulassung (Arzneimittel)
This is from an objection submitted to a court regarding the 'Zulassung' of an Arzneimittel.

Obviously it is clear what Zulassung means in general. But I am unsure what it's specific meaning is in the context of EU medical regulatory law. Does it mean approval, registration, authorisation or licensing? Is there a difference between those four terms in English when used in this context, or can they be used interchangeably?

Some examples from the document:

'Angesichts dessen überrascht es nicht, dass der der Zulassung für XXXX (name of medicine) zugrunde liegende Beurteilungsbericht ebenfalls nicht den europäischen Standards genügt.'

'Die Zulassung für XXXX (name of medicine) wurde in Tschechien am XX Juli 2005 beantragt.'

etc. etc.

I have been using licence/licensing throughout, but then it struck me that, if 'licence' is what is meant, why didn't the author use Lizenz?

Any thoughts from pharma/EU regulation specialists gratefully received.

Thanks.
Marc Rothman
United Kingdom
marketing authorisation
Explanation:
... at least according to the European Medicines Agency (EMA). See, for example, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation...
Selected response from:

Steffen Walter
Germany
Local time: 14:09
Grading comment
Thanks
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +12marketing authorisation
Steffen Walter
3 +5approval
Ramey Rieger (X)
4 +2licensing
Alexander Schleber (X)


  

Answers


4 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +12
marketing authorisation


Explanation:
... at least according to the European Medicines Agency (EMA). See, for example, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation...

Steffen Walter
Germany
Local time: 14:09
Specializes in field
Native speaker of: Native in GermanGerman
PRO pts in category: 186
Grading comment
Thanks

Peer comments on this answer (and responses from the answerer)
agree  Charles Stanford
15 mins
agree  Tatijana Kostovska: I agree, and can confirm as I have worked in the regulatory affairs department of a pharmacutical company and am a certified drug safety manager
29 mins
agree  Ramey Rieger (X): I don't deny the correctness, Steffen! However, this not an EMA document, and I am wary of using their terminology, having fallen on my face with it not too long ago.//Which is why I agree with your suggestion.
40 mins
  -> I tend to disagree because you should use the 'official' terminology in any matters related to EU law (asker specifically mentions 'context of EU medical regulatory law'). / See also http://ec.europa.eu/health/documents/eudralex/vol-2_en
agree  philgoddard
1 hr
agree  Jonathan MacKerron: 100 pro
1 hr
agree  Siegfried Armbruster
2 hrs
agree  Susanne Rindlisbacher
2 hrs
agree  Michele Fauble
2 hrs
agree  BrigitteHilgner
4 hrs
agree  Susanne Schiewe
5 hrs
agree  Elif Baykara Narbay
8 hrs
agree  Carola Lange
1 day 6 hrs
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10 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +5
approval


Explanation:
I know this as approval, when a medication is released on the market.

Ramey Rieger (X)
Germany
Local time: 14:09
Native speaker of: English
PRO pts in category: 24

Peer comments on this answer (and responses from the answerer)
agree  Andrew Bramhall: sounds more natural to me;
17 mins
  -> Yes, it does.
agree  Jacek Kloskowski
21 mins
  -> I approve, too.
neutral  Steffen Walter: This is not what the EMA uses at the EU level (asker indicated EU context).
23 mins
  -> Yes, Steffen, but this is not an EMA doc.
agree  philgoddard
1 hr
agree  Michael Martin, MA: Steffen has a case but I still prefer the more common terminology
1 hr
agree  Wendy Streitparth
2 hrs
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
licensing


Explanation:
Medicines are usually licensed by a governmental organization. I believe this is the most frequnetly used term.

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Note added at 1 hr (2017-03-19 14:17:52 GMT)
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Suchergebnisse
Advanced therapy medicinal products: regulation and licensing - Gov.uk
https://www.gov.uk/.../advanced-therapy-medicinal-products-r...
Diese Seite übersetzen
26.01.2015 - If you are still uncertain fill out the ATMP advice form or go to EMA website for information about classification and to apply to get an opinion ...
Apply for a licence to market a medicine in the UK - GOV.UK
https://www.gov.uk/.../apply-for-a-licence-to-market-a-medic...
Diese Seite übersetzen
18.12.2014 - How to license a medicine for sale in the UK and Europe, including ... for PIPs must be submitted to the European Medicines Agency ( EMA ).

Alexander Schleber (X)
Belgium
Local time: 14:09
Native speaker of: Native in GermanGerman, Native in EnglishEnglish

Peer comments on this answer (and responses from the answerer)
agree  philgoddard
20 mins
agree  Wendy Streitparth: Also possible
1 hr
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