obra oficial

English translation: Official publication

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:obra oficial
English translation:Official publication
Entered by: lorenab23

20:41 May 6, 2012
Spanish to English translations [PRO]
Medical - Medical: Pharmaceuticals / obra oficial
Spanish term or phrase: obra oficial
Buenos días,

Me gustaría que me ayudaran con un término al inglés ”obra oficial”, relacionado con la inscripción de un producto farmacológico en el Registro Sanitario. Muchas gracias:

“Que en las Especificaciones Técnicas (ET) enviadas de todos los excipientes no declara las condiciones de almacenamiento de los mismos. No todos los excipientes declaran la Norma técnica u OBRA OFICIAL (Farmacopea USP, BP u otra) a la que se acoge para sus ET. Los excipientes que declaran que realizaan el ensayo para determinar la ausencia de salmonella no declaran de forma adecuada las unidades de esta especificación según OBRAS OFICIALES (ausencia /20 g).”

GVL
Giovanni Castaneda
Peru
Local time: 09:34
Official publication
Explanation:
What they are saying is that they are not citing the official publication/source used for their technical specifications
such as The United States Pharmacopeia (USP), The British Pharmacopeia (BP) or other source/publication

farmacopea
1.f. Libro que recoge las medicinas más frecuentes y el modo de prepararlas y administrarlas.
2. Repertorio que publica cada Estado con todos los aspectos relacionados con la prescripción, uso, efectos, etc., de los medicamentos, y que actúa como norma legal.
RAE

PRIMERA EDICIÓN
La Primera Edición de la Real Farmacopea Española nace en cumplimiento de la Ley del Medicamento, que precisa que "la Real Farmacopea Española comprenderá íntegramente las monografías de la Farmacopea Europea, más aquellas otras peculiares españolas que se determinen
Esta obra engloba, en un sólo volumen, todas las normas de obligado cumplimiento en materia de farmacopea en España, que fija las especificaciones de calidad de los medicamentos de mayor circulación en Europa, y las monografías nacionales, que completan la lista de la Farmacopea Europea, versando sobre productos de interés nacional que no han podido ser asumidos por esta última
http://www.farmacia.es/lasfarma/farmacop.htm

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Note added at 53 mins (2012-05-06 21:34:46 GMT)
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The British Pharmacopoeia (BP) is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organizations involved in pharmaceutical research, development, manufacture and testing.

Pharmacopoeial standards are publicly available and legally enforceable standards of quality for medicinal products and their constituents. The Pharmacopoeia is an important statutory component in the control of medicines which complements and assists the licensing and inspection processes of the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom
http://en.wikipedia.org/wiki/British_Pharmacopoeia


http://en.wikipedia.org/wiki/United_States_Pharmacopeia
Selected response from:

lorenab23
United States
Local time: 07:34
Grading comment
Muchas gracias.
3 KudoZ points were awarded for this answer



Summary of answers provided
4 +1Official publication
lorenab23
4references pharmacopoeias
Patricia ONeill


  

Answers


50 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
Official publication


Explanation:
What they are saying is that they are not citing the official publication/source used for their technical specifications
such as The United States Pharmacopeia (USP), The British Pharmacopeia (BP) or other source/publication

farmacopea
1.f. Libro que recoge las medicinas más frecuentes y el modo de prepararlas y administrarlas.
2. Repertorio que publica cada Estado con todos los aspectos relacionados con la prescripción, uso, efectos, etc., de los medicamentos, y que actúa como norma legal.
RAE

PRIMERA EDICIÓN
La Primera Edición de la Real Farmacopea Española nace en cumplimiento de la Ley del Medicamento, que precisa que "la Real Farmacopea Española comprenderá íntegramente las monografías de la Farmacopea Europea, más aquellas otras peculiares españolas que se determinen
Esta obra engloba, en un sólo volumen, todas las normas de obligado cumplimiento en materia de farmacopea en España, que fija las especificaciones de calidad de los medicamentos de mayor circulación en Europa, y las monografías nacionales, que completan la lista de la Farmacopea Europea, versando sobre productos de interés nacional que no han podido ser asumidos por esta última
http://www.farmacia.es/lasfarma/farmacop.htm

--------------------------------------------------
Note added at 53 mins (2012-05-06 21:34:46 GMT)
--------------------------------------------------


The British Pharmacopoeia (BP) is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organizations involved in pharmaceutical research, development, manufacture and testing.

Pharmacopoeial standards are publicly available and legally enforceable standards of quality for medicinal products and their constituents. The Pharmacopoeia is an important statutory component in the control of medicines which complements and assists the licensing and inspection processes of the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom
http://en.wikipedia.org/wiki/British_Pharmacopoeia


http://en.wikipedia.org/wiki/United_States_Pharmacopeia

lorenab23
United States
Local time: 07:34
Native speaker of: Native in EnglishEnglish, Native in SpanishSpanish
PRO pts in category: 21
Grading comment
Muchas gracias.

Peer comments on this answer (and responses from the answerer)
agree  Jenna Porter-Jacek
4 hrs
  -> Thank you Jenna :-)
Login to enter a peer comment (or grade)

54 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
references pharmacopoeias


Explanation:
That is the name with which the referenced standards are named. Please refer to the question posted in the web reference.


    Reference: http://www.proz.com/kudoz/english_to_spanish/medical%3A_phar...
Patricia ONeill
Local time: 11:34
Native speaker of: Native in SpanishSpanish
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