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  3. Medical: Pharmaceuticals

Nachzulassung

English translation: retroactive approval

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
German term or phrase:Nachzulassung
English translation:retroactive approval
Entered by: Heike Behl, Ph.D.

17:17 Mar 27, 2003
German to English translations [PRO]
Medical - Medical: Pharmaceuticals / Pharmaceutical
German term or phrase: Nachzulassung
Some kind of pharmaceutical approval. What is the English equivalent?
Context:
Nachzulassung von Arzneimitteln, Dokumentation von Arzneimitteln und Kosmetika, Umsetzung der 6. Änderung der EG-Kosmetik- Richtlinie, Sicherheitsbewertungen für Kosmetika.
sylvie malich (X)
Germany
Local time: 03:43
retroactive approval
Explanation:
cf:
Für die Arzneimittel, die bereits bei In-Kraft-Treten dieser geschilderten Neuregelung in Verkehr waren, stellte sich das Problem, dass sie diese Anforderungen noch nicht erfüllen konnten. Um ihre weitere Verkehrsfähigkeit zu erhalten, wurden sie als "fiktiv zugelassen" erklärt. Damit waren diese Arzneimittel den nach dem neuen Arzneimittelgesetz zugelassenen Arzneimitteln rechtlich gleichgestellt. Dies sollte jedoch nur eine Übergangslösung sein, denn die davon betroffenen Arzneimittel mussten nachträglich anhand der aktuell gültigen Prüfkriterien überprüft werden. Das Verfahren zur nachträglichen Überprüfung dieser Medikamente verbirgt sich hinter dem Begriff "Nachzulassung".
Selected response from:

Heike Behl, Ph.D.
Ireland
Local time: 02:43
Grading comment
Thanks, this seems to be it.
sylvie
4 KudoZ points were awarded for this answer



Summary of answers provided
5Certification validity
Gordana Podvezanec
5Retrospective approval
David Moore (X)
3retroactive approval
Heike Behl, Ph.D.


Discussion entries: 4





  

Answers


4 mins   confidence: Answerer confidence 5/5
Certification validity


Explanation:
..Quality Digest Magazine
... discusses the differences between the medical devices and pharmaceutical industries. ... The
report also queries the certification validity of devices covered by ...
www.qualitydigest.com/nov02/articles/04_article.shtml - 39k - Cached - Similar pages
CCNP practice exam
... The certification validity is renewed automatically if 1. By upgrading the certification
level (say by obtaining CCIE) or 2. By getting re-certified. ...
www.simulationexams.com/exam-details/ccnp.htm - 14k - 26 Mar 2003 - Cached - Similar pages


--------------------------------------------------
Note added at 2003-03-27 17:39:53 (GMT)
--------------------------------------------------

Validity of NARM Certification
The North American Registry of Midwives (NARM) The Certified Professional
Midwife (CPM) Information Series Validity and NARM Certification. ...
www.geocities.com/Wellesley/5510/valid.html - 6k - Cached - Similar pages



--------------------------------------------------
Note added at 2003-03-27 17:40:08 (GMT)
--------------------------------------------------

Validity of NARM Certification
The North American Registry of Midwives (NARM) The Certified Professional
Midwife (CPM) Information Series Validity and NARM Certification. ...
www.geocities.com/Wellesley/5510/valid.html - 6k - Cached - Similar pages


PDF]3745-89-05 Validity of laboratory certification. (A) Laboratory ...
File Format: PDF/Adobe Acrobat - View as HTML
Page 1. 3745-89-05 Validity of laboratory certification. (A) Laboratory
certification shall be valid for a period not to exceed three ...
www.epa.state.oh.us/ddagw/rules/37458905.pdf - Similar pages




Gordana Podvezanec
Croatia
Local time: 03:43
Native speaker of: Native in CroatianCroatian
Login to enter a peer comment (or grade)

43 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
retroactive approval


Explanation:
cf:
Für die Arzneimittel, die bereits bei In-Kraft-Treten dieser geschilderten Neuregelung in Verkehr waren, stellte sich das Problem, dass sie diese Anforderungen noch nicht erfüllen konnten. Um ihre weitere Verkehrsfähigkeit zu erhalten, wurden sie als "fiktiv zugelassen" erklärt. Damit waren diese Arzneimittel den nach dem neuen Arzneimittelgesetz zugelassenen Arzneimitteln rechtlich gleichgestellt. Dies sollte jedoch nur eine Übergangslösung sein, denn die davon betroffenen Arzneimittel mussten nachträglich anhand der aktuell gültigen Prüfkriterien überprüft werden. Das Verfahren zur nachträglichen Überprüfung dieser Medikamente verbirgt sich hinter dem Begriff "Nachzulassung".


    Reference: http://www.bah-bonn.de/arzneimittel/zulassung/Nachzulassung....
Heike Behl, Ph.D.
Ireland
Local time: 02:43
Native speaker of: Native in GermanGerman
PRO pts in category: 20
Grading comment
Thanks, this seems to be it.
sylvie
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 5/5
Retrospective approval


Explanation:
There is a shade of difference between "retroactive", meaning applying to or affecting something from a date in the past, where "retrospective" is said to apply to the past, as well as the present and the future. Prefer this to retroactive, but the choice is yours!
See Chambers 21st. Century Dictionary.

David Moore (X)
Local time: 03:43
Native speaker of: English
PRO pts in category: 75
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