Glossary entry

English term or phrase:

Premarket

Serbian translation:

pre stavljanja u promet

Added to glossary by Vesna Maširević
Nov 28, 2016 10:31
7 yrs ago
7 viewers *
English term

Premarket

English to Serbian Medical Medical (general)
Source sentences:
Most Exempt From Premarket Submission
Required Premarket Application
Target audience:
doctors
Change log

Dec 7, 2016 12:40: Vesna Maširević Created KOG entry

Discussion

Vesna Maširević Nov 30, 2016:
Slažem se
Natasa Stankovic Nov 29, 2016:
Mislim da bi takođe moglo i „pre stavljanja u promet“:

ЗАКОН О ЛЕКОВИМА И МЕДИЦИНСКИМ СРЕДСТВИМА
- Носилац дозволе за промет лекова на велико дужан је да пре стављања у промет увезене серије лека, достави Агенцији, ради контроле квалитета лека, узорке те серије увезеног лека, са сертификатом анализе произвођача лека или сертификатом анализе стручног тела за контролу квалитета лекова из друге државе.
http://www.alims.gov.rs/ciril/files/2012/11/zakon-30-2010-10...

LAW ON MEDICINAL PRODUCTS AND MEDICAL DEVICES
- Prior to the imported medicinal product marketing, for the purpose of the medicinal product quality control, a wholesale license holder is obliged to submit to the Agency the samples of the very imported medicinal product batch accompanied with the medicinal product manufacturer certificate of analysis or a certificate of analysis of a professional body for quality control of medicinal products from another country.
http://www.alims.gov.rs/eng/files/2013/04/Law-on-Medicines-a...
AniSt (asker) Nov 29, 2016:
• Class I Most Exempt From Premarket Submission (Najčešće izuzeti od podnošenja zahteva pre stavljanja u promet)
• Class II Premarket Notification (Obaveštenje pre stavljanja u promet)
• Class III Premarket Approval (Odobrenje pre stavljanja u promet)
• Class III Required Premarket Application (Potrebno podnošenje zahteva pre stavljanja u promet)

Da li slažete sa ovim prevodom?

Proposed translations

+4
25 mins
Selected

pre stavljanja na tržište

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices... The applicant must receive FDA approval of its PMA application prior to marketing the device.

http://www.collinsdictionary.com/dictionary/english/premarke...
adjective
of the period before a product is available
Note from asker:
Hvala puno!
Peer comment(s):

agree Natasa Stankovic : pre-market > пре стављања на тржиште (EN: http://www.tehnis.privreda.gov.rs/sw4i/download/files/articl... ; SR: http://www.iss.rs/rs/images/upload/PUBLIKACIJE/horizontalni_... )
7 hrs
Hvala puno Natasa! Nisam uspela na brzinu da nađem SR ref.
agree sofijana
9 hrs
Hvala Sofijana!
agree Miomira Brankovic : bolje „pre stavljanja u promet”, kako je u diskusiji sugerisano
2 days 8 mins
U pravu ste. Hvala!
agree Mira Stepanovic
2 days 44 mins
Hvala Miro!
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4 KudoZ points awarded for this answer.
4 hrs

predtržišno

predtržišno podnošenje zahteva, evo i linka gde se spominje reč (doduše, tekst je bosanski, ali mislim da je ovo ok rešenje)

https://bs.wikipedia.org/wiki/Genetičko_inženjerstvo_u_Evrop...

"EU koristi princip predostrožnosti zahtijevajući predtržišno odobrenje za bilo koji GMO za ulazak na tržište i praćenje životne sredine u post-tržišnom periodu. "
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