Način i mjesto izdavanja lijeka

English translation: GENERAL CLASSIFICATION FOR SUPPLY

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Croatian term or phrase:Način i mjesto izdavanja lijeka
English translation:GENERAL CLASSIFICATION FOR SUPPLY
Entered by: sazo

17:54 Mar 31, 2015
Croatian to English translations [PRO]
Medical - Medical: Pharmaceuticals / marketing authorization
Croatian term or phrase: Način i mjesto izdavanja lijeka
Način i mjesto izdavanja lijeka:

Ako sam iz ovog dokumenta http://www.almp.hr/pdf/pristupanje_EU/Blue_box_requirements.... dobro shvatila, način i mjesto izdavanja lijeka prevodi se kao: Classification for supply. Međutim, ako usporedim ove dokumente Europske agencije za lijekove http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_... i http://www.ema.europa.eu/docs/hr_HR/document_library/EPAR_-_... vidim da se Classification for supply prevodi kao "Način propisivanja lijeka"

Kako bi se onda prevelo način i mjesto izdavanje lijeka.

Hvala na pomoći.
sazo
Croatia
Local time: 17:11
GENERAL CLASSIFICATION FOR SUPPLY
Explanation:
Your own research provided the right answer. Since 'mijesto' and 'nacin' are interdependent, i.e. if it's a POM ( prescription-only medicine), then it is clear that it is only available in the pharmacies rather than in drugstores (US) as OTC, saying Classification for supply suffices.

I have translated numerous PILs/SmPCs, and I always use this phrasing.

HTH
Selected response from:

Lirka
Austria
Local time: 17:11
Grading comment
Odlučila sam se za vaš prijedlog. Ostavila sam i onaj dio za koji ste napisali da je višak uz komentar naručitelju.
4 KudoZ points were awarded for this answer



Summary of answers provided
5 -1Prescription and distribution
Lea Lozančić
4GENERAL CLASSIFICATION FOR SUPPLY
Lirka
2 -1The manner and place of drug issuance
Vitaly Ashkinazi


Discussion entries: 7





  

Answers


1 hr   confidence: Answerer confidence 2/5Answerer confidence 2/5 peer agreement (net): -1
The manner and place of drug issuance


Explanation:
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Vitaly Ashkinazi
Russian Federation
Local time: 18:11
Works in field
Native speaker of: Russian

Peer comments on this answer (and responses from the answerer)
disagree  Lirka: sorry, but not really. EMA templates must be observed, it's not a free translation
56 mins
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2 hrs   confidence: Answerer confidence 5/5 peer agreement (net): -1
Prescription and distribution


Explanation:
100% sam sigurna jer mi je mama mag.pharm. s dugogodišnjim radnim iskustvom

Način i mjesto izdavanja lijeka: na recept, u ljekarni
= Prescription and distribution

(ovo se obično piše kada se radi o lijeku koji se izdaje na liječnički recept)

ili
Način i mjesto izdavanja lijeka: bez recepta, u ljekarni
kao paracetamol
http://www.jgl.hr/media/926118/paracetamol-pil_obnova__odobr...

Način izdavanja lijeka -
1. na recept (ponavljajući recept, ograničeni recept)
2. bez recepta

Mjesto izdavanja lijeka: u ljekarni

Ime i adresa nositelja odobrenja/proizvođača lijeka
Način i mjesto izdavanja lijeka
Datum revizije upute

SI
Imetnik dovoljenja za prometNačin in režim izdaje zdravila
Predpisovanje in izdaja zdravila je le na recept.

Naše zakonodavstvo traži takvu formulaciju, no to ne zahtijeva zakonodavstvo drugih DČ. Primjerice, zakonodavtsvo UK traži sljedeće:

Legal Status
The legal status is required on the labelling.
Labelling must include an indication of the legal status as follows:
Medicines for supply only on the prescription of a medical practitioner
- the letters POM in black surrounded by a box
Medicines which may be supplied without prescription only under the supervision of a registered pharmacist - the letter P in black surrounded by a box

Some additional statements are required to appear by law on the labelling and/or the package leaflet for certain medicines. The requirements are set out in current UK legislation.

http://www.almp.hr/pdf/pristupanje_EU/Blue_box_requirements....

Lea Lozančić
Local time: 17:11
Specializes in field
Native speaker of: Native in CroatianCroatian, Native in ItalianItalian

Peer comments on this answer (and responses from the answerer)
disagree  Lirka: sorry to hear that you're 100% sure; the idea is right, but the phrasing is not (EMA tempalte must be observed). In addition, izdavanje lijeka is 'dispensing' in English rather than 'distribution'.
8 mins
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2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
GENERAL CLASSIFICATION FOR SUPPLY


Explanation:
Your own research provided the right answer. Since 'mijesto' and 'nacin' are interdependent, i.e. if it's a POM ( prescription-only medicine), then it is clear that it is only available in the pharmacies rather than in drugstores (US) as OTC, saying Classification for supply suffices.

I have translated numerous PILs/SmPCs, and I always use this phrasing.

HTH

Lirka
Austria
Local time: 17:11
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 36
Grading comment
Odlučila sam se za vaš prijedlog. Ostavila sam i onaj dio za koji ste napisali da je višak uz komentar naručitelju.

Peer comments on this answer (and responses from the answerer)
disagree  Lea Lozančić: ne bo šlo
21 mins
  -> and why is that?

agree  Veronica Prpic Uhing: SmPC version 9
1 day 17 hrs
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