This question was closed without grading. Reason: Other
Apr 8, 2020 16:35
4 yrs ago
28 viewers *
English term
Have been referred to the published
English to Spanish
Medical
Medical: Pharmaceuticals
Buenas, en medio de un texto en portugués sobre una autorización de comercialización de un documento me aparece la siguiente frase y me he bloqueado, ya no sé si no la entiendo bien o si la redacción es confusa:
The approved SPC, PIL and labelling have been referred to the published in variation procedure UK/H/0803/001/II/017/G.
Toda sugerencia será bienvenida, gracias.
The approved SPC, PIL and labelling have been referred to the published in variation procedure UK/H/0803/001/II/017/G.
Toda sugerencia será bienvenida, gracias.
Proposed translations
(Spanish)
| 4 +4 | se han remitido (al procedimiento de variación) ya publicado |
Lydia De Jorge
|
| 3 +1 | se han remitido a [la información] publicada en |
Neil Ashby
|
Proposed translations
+4
6 mins
Lydia De Jorge
United States
United States
Native in English
&
Spanish
United States
Don't just say it, say it right!
Native in: Spanish 
, English
Works in: English to Spanish, Spanish to English, English, and 1 more.
Related KudoZ points
:
28
se han remitido (al procedimiento de variación) ya publicado
suggestion
+1
8 mins
Neil Ashby
Spain
Spain
Native in English
Specializes in field
Spain
DrNeil TechTrans, Precision & Clarity
Native in: English
Works in: Spanish to English, English
Related KudoZ points
:
241
se han remitido a [la información] publicada en
.
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Note added at 9 mins (2020-04-08 16:45:43 GMT)
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The change is not a consequence of any commitment from previous assessments to review specification limits (e.g. made during the procedure for the marketing authorisation application or a type II variation procedure).
https://ec.europa.eu/health/sites/health/files/files/betterr...
--------------------------------------------------
Note added at 9 mins (2020-04-08 16:45:43 GMT)
--------------------------------------------------
The change is not a consequence of any commitment from previous assessments to review specification limits (e.g. made during the procedure for the marketing authorisation application or a type II variation procedure).
https://ec.europa.eu/health/sites/health/files/files/betterr...
Reference comments
14 mins
Reference:
Tiene sido relacionado com las publicaciones hechas
Definition of refer to: to have a direct connection or relationship to (something) - https://www.merriam-webster.com/dictionary/refer to
Peer comments on this reference comment:
| neutral |
Neil Ashby
: Firstly, not sure what "tiene sido relacionado com" means. Secondly, "refer" has a few more definitions and uses depending on context (consult, send on to, recommend, mention, amongst others).
23 hrs
|
25 mins
Taña Dalglish
Jamaica
Jamaica
Native in English
Jamaica
Translating the Ideas Behind the Words
Native in: English (Variant: British)
Works in: Spanish to English, English to Spanish, French to English, and 2 more.
Related KudoZ points
:
48
Reference:
Ref./Comments
I think that it could mean: "The approved SPC, PIL and labelling have been published in the referenced variation procedure UK/H/0803/001/II/017/G"; your text is certainly confusing and may be a poor translation (from Protuguese?), but I think it is the same idea being conveyed. I could not find "UK/H/0803/001/II/017/G", but below is a similar document.
Levonelle Art 13; INN: levonorgestrel - European Medicines ...www.ema.europa.eu › docs › document_library › Referrals_document
PDF
Jun 17, 2015 - Committee for Medicinal Products for Human Use (CHMP) ... Information on the procedure . ... recognition procedure (MRP) type II variation (UK/H/0803/001/II/022) ... to the summary of product characteristics (SmPC) and package leaflet (PL) ... 750mcg of LNG and it is approved for emergency contraception ...
SPC > Summary of Product Characteristics
PIL > Package Information Leaflet
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Note added at 10 days (2020-04-18 16:53:33 GMT)
--------------------------------------------------
Yikes ... should have been "Portuguese?); not the rubbish I wrote!
Levonelle Art 13; INN: levonorgestrel - European Medicines ...www.ema.europa.eu › docs › document_library › Referrals_document
Jun 17, 2015 - Committee for Medicinal Products for Human Use (CHMP) ... Information on the procedure . ... recognition procedure (MRP) type II variation (UK/H/0803/001/II/022) ... to the summary of product characteristics (SmPC) and package leaflet (PL) ... 750mcg of LNG and it is approved for emergency contraception ...
SPC > Summary of Product Characteristics
PIL > Package Information Leaflet
--------------------------------------------------
Note added at 10 days (2020-04-18 16:53:33 GMT)
--------------------------------------------------
Yikes ... should have been "Portuguese?); not the rubbish I wrote!
Note from asker:
| Gracias por tu comentario. Coincide con mi idea de que se trata de una mala traducción y, sí, es muy probable que el original sea portugués, por tanto, tu aportación tiene mucho sentido. |
Peer comments on this reference comment:
| agree |
Neil Ashby
: This also makes sense, and is different from Lydia's suggestion and mine.
22 hrs
|
|
Thanks Neil. Appreciate your agree. Continue to stay safe, my friend!
|
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