Glossary entry (derived from question below)
French term or phrase:
AMM sous circonstances exceptionnelles
English translation:
marketing autorisation (granted) under exceptional circumstances
Added to glossary by
Rachel Fell
Oct 18, 2009 20:49
14 yrs ago
6 viewers *
French term
Retired as of Jan 2019!
Native in: English
Works in: German to English, French to English
AMM sous circonstances exceptionnelles
French to English
Medical
Medical: Pharmaceuticals
Heading in a package insert, under which stands "Sans objet". Do I understand this correctly to mean "Marketing authorisation granted under special conditions (provisos?)" or some such like?
Thanks in advance,
J.
Thanks in advance,
J.
Proposed translations
(English)
| 3 +6 | marketing autorisation (granted) under exceptional circumstances |
Rachel Fell
|
| 4 | Marketing authorisation available under a special restricted distribution program |
Drmanu49
|
Change log
Oct 23, 2009 10:40: Rachel Fell changed "Edited KOG entry" from "<a href="/profile/34828">Jonathan MacKerron's</a> old entry - "AMM sous circonstances exceptionnelles"" to ""marketing autorisation (granted) under exceptional circumstances""
Proposed translations
+6
2 hrs
Rachel Fell
United Kingdom
United Kingdom
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Specializes in field
United Kingdom
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Native in: English (Variant: UK) 
Works in: French to English, Spanish to English, Italian to English, and 4 more.
Related KudoZ points
:
44
Selected
marketing autorisation (granted) under exceptional circumstances
32. Marketing authorisation under exceptional circumstances
Legal basis and Criteria
The legal basis for the marketing authorisation (MA) under exceptional circumstances is the Article 14 (8) of the Regulation (EC) No 276/2004, and the relevant documentation for applications in exceptional circumstances are laid down in Part II of Annex I of Directive 2001/83/EC, as amended.
Products for which the applicant can demonstrate in this application that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because:
http://www.emea.europa.eu/htms/human/presub/q32.htm
[PDF]
Compassionate Use of Vaccines
File Format: PDF/Adobe Acrobat - Quick View
Marketing authorisation under exceptional circumstances. Guideline on procedures for the granting of a marketing authorisation under exceptional ...
www.vakzine-manager.de/fileadmin/vpm/.../VDD.../Schwanig.pd... -
Legal basis and Criteria
The legal basis for the marketing authorisation (MA) under exceptional circumstances is the Article 14 (8) of the Regulation (EC) No 276/2004, and the relevant documentation for applications in exceptional circumstances are laid down in Part II of Annex I of Directive 2001/83/EC, as amended.
Products for which the applicant can demonstrate in this application that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because:
http://www.emea.europa.eu/htms/human/presub/q32.htm
[PDF]
Compassionate Use of Vaccines
File Format: PDF/Adobe Acrobat - Quick View
Marketing authorisation under exceptional circumstances. Guideline on procedures for the granting of a marketing authorisation under exceptional ...
www.vakzine-manager.de/fileadmin/vpm/.../VDD.../Schwanig.pd... -
4 KudoZ points awarded for this answer.
Comment: "Thanks to you all!"
3 mins
Marketing authorisation available under a special restricted distribution program
or as you correctly suggested
Marketing authorisation granted under special conditions (provisos)
20 Jun 2007 ... The Marketing Authorization Application (MAA) for REVLIMID was based upon the safety and ... is only available under a special restricted distribution program. ... and meet all the conditions of the RevAssist(R) program. ...
www.medicalnewstoday.com/.../74714.php -
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Note added at 3 mins (2009-10-18 20:53:56 GMT)
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European Commission has granted marketing authorization under exceptional ... Following marketing authorization granted by the MCA, Connetics intends to . ...
www.highbeam.com/.../1G1-86228943.html -
Marketing authorisation granted under special conditions (provisos)
20 Jun 2007 ... The Marketing Authorization Application (MAA) for REVLIMID was based upon the safety and ... is only available under a special restricted distribution program. ... and meet all the conditions of the RevAssist(R) program. ...
www.medicalnewstoday.com/.../74714.php -
--------------------------------------------------
Note added at 3 mins (2009-10-18 20:53:56 GMT)
--------------------------------------------------
European Commission has granted marketing authorization under exceptional ... Following marketing authorization granted by the MCA, Connetics intends to . ...
www.highbeam.com/.../1G1-86228943.html -
Note from asker:
| thanks for confirming that I was at least on the right track |
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