TSE freeness

Serbo-Croat translation: odsustvo TSE

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:TSE freeness
Serbo-Croat translation:odsustvo TSE
Entered by: Natasa Djurovic

10:24 Apr 28, 2009
English to Serbo-Croat translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: TSE freeness
1.3 “REGISTRATION DOSSIER”, “DOSSIER” shall mean a document supplied by LICENSOR according to the requirements of the European Union by the date of signature of this Agreement, limited to the Common Technical Documentation (CTD); such document being necessary and useful for the grant of the MARKETING AUTHORIZATIONS for the related PRODUCTS. REGISTRATION DOSSIER shall contain all relevant analytical, technical and galenical data and batch records as well as stability tests, bioequivalence studies and comparative dissolution testing for the TERRITORY, Declaration Letters about Manufacturer, DMF, certificate of TSE freeness according to applicable EU-guidelines and Letter of Access
Bogdan Petrovic
Serbia
Local time: 17:30
odsustvo TSE
Explanation:
http://www.tga.gov.au/docs/html/devguid14.htm

Potvrda o odsustvu TSE.

Odnosi se na medikamente koji sadrže u sebi materijal koji je životinjskog porekla, a prenosiv je i utiče na zdravlje ljudi.U skladu sa EU regulativom medikamenti moraju imati potvrdu o odsustvu TSE.
Selected response from:

Natasa Djurovic
Serbia
Local time: 17:30
Grading comment
to sam stavio, hvala!
4 KudoZ points were awarded for this answer



Summary of answers provided
3tse neovisnost
Larisa Djuvelek-Ruggiero (X)
3odsustvo TSE
Natasa Djurovic
Summary of reference entries provided
liz askew

  

Answers


1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5
tse freeness
tse neovisnost


Explanation:
prenosna spongiformna encefalopatija

Nisam sigurna kako bi formulisala certificate of freeness
Mozda certifikat o neovisnosti, postedi, izuzecu i sli...

Mozda neko ima bolji predlog...:)

Larisa Djuvelek-Ruggiero (X)
United States
Local time: 11:30
Works in field
Native speaker of: Native in BosnianBosnian
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3 days 21 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
tse freeness
odsustvo TSE


Explanation:
http://www.tga.gov.au/docs/html/devguid14.htm

Potvrda o odsustvu TSE.

Odnosi se na medikamente koji sadrže u sebi materijal koji je životinjskog porekla, a prenosiv je i utiče na zdravlje ljudi.U skladu sa EU regulativom medikamenti moraju imati potvrdu o odsustvu TSE.

Natasa Djurovic
Serbia
Local time: 17:30
Works in field
Native speaker of: Native in SerbianSerbian
PRO pts in category: 20
Grading comment
to sam stavio, hvala!
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Reference comments


13 mins peer agreement (net): +1
Reference

Reference information:
TSE =

[PDF]
Note for guidance on minimising the risk of transmitting animal ...
File Format: PDF/Adobe Acrobat
This revision of the TSE (Transmissible Spongiform Encephalopathy) note for guidance has been .... By definition, the principle of specified risk materials as defined ..... as New Zealand or Australia or from proven TSE-free flocks. ...
www.emea.europa.eu/pdfs/human/bwp/TSE NFG 410-rev2.pdf - Similar pages

liz askew
United Kingdom
Works in field
Native speaker of: Native in EnglishEnglish

Peer comments on this reference comment (and responses from the reference poster)
agree  Natasa Djurovic
3 days 23 hrs
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