Korlátozott érvényű orvosi rendelvényhez kötött gyógyszer

English translation: Medicinal product subject to restricted medical prescription

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Hungarian term or phrase:Korlátozott érvényű orvosi rendelvényhez kötött gyógyszer
English translation:Medicinal product subject to restricted medical prescription
Entered by: Katalin Szilárd

18:45 Jul 6, 2018
Hungarian to English translations [PRO]
Medical - Medical: Pharmaceuticals / SmPC
Hungarian term or phrase: Korlátozott érvényű orvosi rendelvényhez kötött gyógyszer
Sziasztok!

Egy alkalmazási leírásban szerepel a következő mondat:

Korlátozott érvényű orvosi rendelvényhez kötött, az egészségügyről szóló 1997. évi CLIV. törvény 3. §‑ának ga) pontja szerinti rendelőintézeti járóbeteg-szakellátást vagy fekvőbeteg-szakellátást nyújtó szolgáltatók által biztosított körülmények között alkalmazható gyógyszer (I).

Én így fordítottam egyelőre, de érdekelne, hogy vajon helyes-e ez így, vagy máshogyan írnátok...:

Medicinal product subject to restricted medical prescription. It is applicable in conditions guaranteed by healthcare providers offering clinic outpatient care or inpatient care as defined in point ga) at §3 of Act CLIV of 1997 on Health (I).
András Illyés
Local time: 01:13
Medicinal product subject to restricted medical prescription
Explanation:
Azért nem adtam meg válaszként, mert amit írtál az a helyes. :)

De akkor íme, hogy aki esetleg később keresi, az is megtalálja:

http://apps.who.int/medicinedocs/en/d/Js6168e/4.3.html


ANNEX I - Summary of product characteristics -

B. CONDITIONS OF THE MARKETING AUTHORISATION

• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER


<Medicinal product subject to restricted medical prescription

--------------------------------------------------
Note added at 1 day 51 mins (2018-07-07 19:37:10 GMT)
--------------------------------------------------

http://www.ema.europa.eu/docs/en_GB/document_library/Regulat...

5. oldal

Page 5/8
©
EMEA 2006

Medicinal product subject to restricted medical prescription
, where the medicinal product:
-
is reserved for treatments which can only be followed in a hospital environment, because of its pharmaceutical characteristics or novelty
or in the interests of public health,
-
is used in the treatment of conditions which mu
st be diagnosed in a hospital environment or in
institutions with adequate diagnostic facilities,
although administration and follow-up may be
carried out elsewhere, or
- is intended for outpatients but its use may produce very serious adverse reactions requiring a
prescription drawn up as required by a specialist and special supervision throughout the treatment.

és 6. oldal SPC-kben.
Selected response from:

Katalin Szilárd
Hungary
Local time: 01:13
Grading comment
Köszi, az jó ha meg lehet találni, elég sokmindent itt kerestem meg az évek során :)
4 KudoZ points were awarded for this answer



Summary of answers provided
5Medicinal product subject to restricted medical prescription
Katalin Szilárd
5controlled drug
JANOS SAMU
4Time-limited prescription medication
Katarina Peters


Discussion entries: 11





  

Answers


8 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
Time-limited prescription medication


Explanation:
:)

Katarina Peters
Canada
Local time: 19:13
Works in field
Native speaker of: Native in HungarianHungarian, Native in EnglishEnglish
Notes to answerer
Asker: Köszönöm a választ, Katié lesz mert azt írja az EMEA doksikban mindenhol így kell szerepelnie angolul, hogy Medicinal product subject to restricted medical prescription.

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24 mins   confidence: Answerer confidence 5/5
controlled drug


Explanation:
Ez a legegyszerűbb, mert minden korlátozás belefér. Lásd itt:
https://www.tricare.mil/CoveredServices/Pharmacy/FillPrescri...
Én így fordítanám:

Controlled drug that may be used only under circumstances present in outpatient clinics with specialized services and inpatient facilities providing specialized services as set forth in Act 64 of 1997 on healthcare, section 3, item ga) (I).

JANOS SAMU
United States
Local time: 14:13
Works in field
PRO pts in category: 8
Notes to answerer
Asker: Ezt is köszönöm, Kati szerint az EMEA dokumentumokban mindenhol Medicinal product subject to restricted medical prescription, de tetszik a Controlled drug és a teljes mondat fordítása is, sokkal jobb, mint amit én írtam.

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1 day 50 mins   confidence: Answerer confidence 5/5
Medicinal product subject to restricted medical prescription


Explanation:
Azért nem adtam meg válaszként, mert amit írtál az a helyes. :)

De akkor íme, hogy aki esetleg később keresi, az is megtalálja:

http://apps.who.int/medicinedocs/en/d/Js6168e/4.3.html


ANNEX I - Summary of product characteristics -

B. CONDITIONS OF THE MARKETING AUTHORISATION

• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER


<Medicinal product subject to restricted medical prescription

--------------------------------------------------
Note added at 1 day 51 mins (2018-07-07 19:37:10 GMT)
--------------------------------------------------

http://www.ema.europa.eu/docs/en_GB/document_library/Regulat...

5. oldal

Page 5/8
©
EMEA 2006

Medicinal product subject to restricted medical prescription
, where the medicinal product:
-
is reserved for treatments which can only be followed in a hospital environment, because of its pharmaceutical characteristics or novelty
or in the interests of public health,
-
is used in the treatment of conditions which mu
st be diagnosed in a hospital environment or in
institutions with adequate diagnostic facilities,
although administration and follow-up may be
carried out elsewhere, or
- is intended for outpatients but its use may produce very serious adverse reactions requiring a
prescription drawn up as required by a specialist and special supervision throughout the treatment.

és 6. oldal SPC-kben.

Katalin Szilárd
Hungary
Local time: 01:13
Specializes in field
Native speaker of: Native in HungarianHungarian
PRO pts in category: 38
Grading comment
Köszi, az jó ha meg lehet találni, elég sokmindent itt kerestem meg az évek során :)
Login to enter a peer comment (or grade)



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