zdruzena sprememba tipa II

English translation: grouped type II variation

23:15 Dec 17, 2012
Slovenian to English translations [PRO]
Medical - Medical: Pharmaceuticals
Slovenian term or phrase: zdruzena sprememba tipa II
Gre za odobritev spremembe pogojev dovoljenja za promet z zdravilom XY, zdruzena sprememba tipa II

"Javna agencija RS za zdravila in medicinske pripomocke odobri zdruzeno spremembo pogojev dovoljenja za promet z zdravilom XY."

Kaksna je zdruzena sprememba? Nisem zasledila referenc na spletu glede "zdruzene" spremembe v angl. terminologiji. So samo spremembe tipa I ali II.

Mi kdo lahko osvetli pojem?

Hvala!
Lirka
Austria
Local time: 21:56
English translation:grouped type II variation
Explanation:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation...

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Note added at 15 hrs (2012-12-18 14:26:03 GMT)
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you can say grouped for type II as well worksharing is usually applied when PSURs are in question.
Selected response from:

Dinap
Croatia
Local time: 21:56
Grading comment
ok, pa naj bo grouped. hvala
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1grouped type II variation
Dinap


  

Answers


10 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
grouped type II variation


Explanation:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation...

--------------------------------------------------
Note added at 15 hrs (2012-12-18 14:26:03 GMT)
--------------------------------------------------

you can say grouped for type II as well worksharing is usually applied when PSURs are in question.

Dinap
Croatia
Local time: 21:56
Specializes in field
Native speaker of: Native in CroatianCroatian
PRO pts in category: 27
Grading comment
ok, pa naj bo grouped. hvala
Notes to answerer
Asker: Hvala, sem opazila tole "grouped", ampak zdi se mi, da se nanasa le na type I variations. Za type II je predlog 'worksharing". Res ne vem...


Peer comments on this answer (and responses from the answerer)
agree  Tina Dolinar: Lahko tudi "type II grouped variation" (tudi na straneh EMA)
44 mins
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