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Zulassung

English translation: approval (by the governing authority/agency)

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
German term or phrase:Zulassung (neuer Medikamente)
English translation:approval (by the governing authority/agency)
Entered by: Michael Sebold
Options:
- Contribute to this entry
- Include in personal glossary

20:44 Mar 7, 2002
German to English translations [Non-PRO]
Medical - Medical: Pharmaceuticals / drugs
German term or phrase: Zulassung
What's the correct term for the Zulassung of a drug? "arzneimittelrechtliche Zulassung"
AmiHH
Germany
Local time: 02:07
approval
Explanation:
As in FDA approval.

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Note added at 2002-03-07 21:33:02 (GMT)
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I would say: \"The (name of agency granting approval) has approved Prozac for clinical use in Nicaragua.\"
Selected response from:

Michael Sebold
Canada
Local time: 20:07
Grading comment
Thanks everyone. Unfortunately, it was not clear who granted approval...just where...and it wasn't "Nicaragua," of course. (That was just used as an example) I used a variation of your suggestion.
4 KudoZ points were awarded for this answer

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Summary of answers provided
5 +11approvalMichael Sebold
5marketing authorisation or approval
Paul André Arend
4approval by the Health MinistryUschi (Ursula) Walke
4 -1re lease or release for use
Dr. Fred Thomson


Discussion entries: 1





  

Answers


2 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): -1
re lease or release for use


Explanation:
Standard

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Note added at 2002-03-07 20:47:59 (GMT)
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Sometimes it is approved for use

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Note added at 2002-03-07 23:43:27 (GMT)
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Your first sentence is better than the second.

Dr. Fred Thomson
United States
Local time: 18:07
Native speaker of: English
PRO pts in category: 44

Peer comments on this answer (and responses from the answerer)
disagree  Paul André Arend: This is simply wrong under drug law
2 hrs
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2 mins   confidence: Answerer confidence 5/5 peer agreement (net): +11
approval


Explanation:
As in FDA approval.

--------------------------------------------------
Note added at 2002-03-07 21:33:02 (GMT)
--------------------------------------------------

I would say: \"The (name of agency granting approval) has approved Prozac for clinical use in Nicaragua.\"

Michael Sebold
Canada
Local time: 20:07
Grading comment
Thanks everyone. Unfortunately, it was not clear who granted approval...just where...and it wasn't "Nicaragua," of course. (That was just used as an example) I used a variation of your suggestion.

Peer comments on this answer (and responses from the answerer)
agree  Elisabeth Ghysels
1 min
  -> Thanks, Elisabeth.

agree  Terri Doerrzapf: yep, that's it
6 mins
  -> Thanks, Terri.

agree  wrtransco
8 mins
  -> Thank you.

agree  pschmitt: yes, medicinal drug approval
18 mins
  -> Thank you.

agree  Trudy Peters
1 hr
  -> Thanks, Trudy.

agree  ingot
1 hr
  -> Thank you.

agree  Johanna Timm, PhD: genau
1 hr
  -> Thanks, Johanna.

agree  Andrea Kopf
2 hrs
  -> Thanks, Andrea.

agree  Steven Sidore
5 hrs
  -> Thank you.

agree  jccantrell
7 hrs
  -> Thanks, JC.

agree  Elvira Stoianov
10 hrs
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3 hrs   confidence: Answerer confidence 5/5
marketing authorisation or approval


Explanation:
marketing authorisation for a Zulassung under Community Law either by mutual recognition or the so-called centralised procedure(cf. Notice to applications, directives 65/65 ff.)
approval for an FDA Zulassung

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Note added at 2002-03-07 23:54:57 (GMT)
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Sorry, correct title of document: Notice to Applicants

Paul André Arend
Local time: 02:07
Specializes in field
Native speaker of: German
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7 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
approval by the Health Ministry


Explanation:
of Nicaragua.

The only difference to your own suggestion is,
that the use of any medical drugs in Nicaragua has to be approved by the Nicaraguan Ministry/Department of Health and nobody else.

If approved you have to state WHO approved the use and marketing of the medicine/drug.

Had to capitalize the WHO, no intention to confuse with interferance of the World Health Organization. They could recommend but not approve.

If you mentioned Nicaragua just as an example, you'd have to find out the name of the authorizing department of the country concerned.

HTH

Uschi (Ursula) Walke
Local time: 10:07
Native speaker of: Native in GermanGerman
PRO pts in category: 4

Peer comments on this answer (and responses from the answerer)
neutral  Michael Sebold: Uschi, I have to ask you quite innocently: How does your suggestion materially differ from mine? To echo another peer's observation, there are options for adding comments . . .
54 mins
  -> Hi, 'msebold'! I tried to emphasize that 'approval' was not sufficient without mentioning the authority who gave the approval, and there is not enough room in the comments-box. I withdraw my suggestion and wish you good luck.
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