Glossary entry

Croatian term or phrase:

Način i mjesto izdavanja lijeka

English translation:

GENERAL CLASSIFICATION FOR SUPPLY

Added to glossary by sazo
Mar 31, 2015 17:54
9 yrs ago
25 viewers *
Croatian term

Način i mjesto izdavanja lijeka

Croatian to English Medical Medical: Pharmaceuticals marketing authorization
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.

Discussion

bonafide1313 Apr 2, 2015:
Copy paste s halmeda :) Prescription and distribution na recept, u ljekarni
Type of prescription ograničeni recept ... možda ti to može pomoći?
http://www.halmed.hr/?ln=en&w=lijekovi&d=opsirnije&id=5461
Lirka Apr 1, 2015:
@Sazo, go ahead and use the following: "General classification for supply: prescription-only medicine."

You don't have to repeat it as it is redundant ( in the original text). This suffices for sure.
sazo (asker) Apr 1, 2015:
Kopirala sam i zalijepila tekst:

Način i mjesto izdavanja lijeka: na recept, u ljekarni
Način propisivanja lijeka: ograničeni recept


Lirka Mar 31, 2015:
@ sazo: koja izraza tacno su jedan ispod drugoga? :)
sazo (asker) Mar 31, 2015:
@lirika, zanemarite moj prethodni komentar. Moj problem je sto su oba izraza jedan ispod drugoga i nisam sigurna kako to rijesti.
sazo (asker) Mar 31, 2015:
@lirika, would you translate... Nacin propisivanja lijeka as prescription and distribution? I can't find that term in the EMA templates.
sazo (asker) Mar 31, 2015:
Ovdje http://www.almp.hr/?ln=en&w=lijekovi&d=opsirnije&id=9106 vidim prescription and distribution. Očito sam malo zbunjena.

Proposed translations

2 hrs
Selected

GENERAL CLASSIFICATION FOR SUPPLY

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
Peer comment(s):

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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4 KudoZ points awarded for this answer. Comment: "Odlučila sam se za vaš prijedlog. Ostavila sam i onaj dio za koji ste napisali da je višak uz komentar naručitelju. "
-1
1 hr

The manner and place of drug issuance

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Перевести эту страницу
... established indicates that the drug issuance of an administrative order by the ... If you have questions graduates is that you already know this a timely manner.
[PDF]Audit Report on the Inventory Controls of The Woodhull ...
comptroller.nyc.gov/legacy-url/?q.../audit/...
Перевести эту страницу
28 июня 2002 г. - place by HHC and Woodhull Hospital over non-controlled drugs, as well as over medical ..... to determine the dollar value of its inventory in a timely manner. ..... units—the record of the drug's issuance could vary as follows: 1.
Peer comment(s):

disagree Lirka : sorry, but not really. EMA templates must be observed, it's not a free translation
56 mins
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-1
2 hrs

Prescription and distribution

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....
Peer comment(s):

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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