notificación sanitaria

English translation: (notification of) authorisation (from the competent authority)

13:33 Jun 9, 2018
Spanish to English translations [PRO]
Law/Patents - Medical: Pharmaceuticals
Spanish term or phrase: notificación sanitaria
(medicamentos) están sujetos a la obtención de **notificación sanitaria** previamente a su comercialización

La fabricación bajo la modalidad de campaña de productos naturales procesados de uso medicinal y suplementos alimenticios, debe ser notificada a la ARCSA treinta (30) días previos a la fabricación de la misma, indicando la fecha a fabricar bajo la modalidad de campaña, el producto y el número de registro sanitario o **notificación sanitaria**, según corresponda.

The context is pharmaceutical regulations for medicinal products in Ecuador.
Matthew Dykes
Spain
Local time: 06:21
English translation:(notification of) authorisation (from the competent authority)
Explanation:
It means the drug (product) in question has to be approved/authorised/certified by the competent authority. In this case, "sanitaria" refers to the health authority, for example the NHS and similar bodies in the UK, or the EMA at EU level.
I'd usually call this "certified/certification", but there may not be an actual certificate issued.
The Spanish term just means "notification of approval..." IMHO.

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Note added at 1 hr (2018-06-09 15:23:04 GMT)
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I have no idea which organisation is responsible for that sort of thing in Ecuador, but in LatAm they probably follow the US model, with something equivalent to the FDA.
Selected response from:

neilmac
Spain
Local time: 06:21
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1(notification of) authorisation (from the competent authority)
neilmac
Summary of reference entries provided
Notificación sanitaria (autorización de comercialización)
Chema Nieto Castañón

  

Answers


1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
(notification of) authorisation (from the competent authority)


Explanation:
It means the drug (product) in question has to be approved/authorised/certified by the competent authority. In this case, "sanitaria" refers to the health authority, for example the NHS and similar bodies in the UK, or the EMA at EU level.
I'd usually call this "certified/certification", but there may not be an actual certificate issued.
The Spanish term just means "notification of approval..." IMHO.

--------------------------------------------------
Note added at 1 hr (2018-06-09 15:23:04 GMT)
--------------------------------------------------

I have no idea which organisation is responsible for that sort of thing in Ecuador, but in LatAm they probably follow the US model, with something equivalent to the FDA.


    Reference: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/...
neilmac
Spain
Local time: 06:21
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 208

Peer comments on this answer (and responses from the answerer)
agree  philgoddard
1 hr

neutral  Robert Carter: "Registro sanitario" and "notificación sanitaria" are two different concepts. The "notificación" refers to processed food, not drugs, and I'm not sure it's an authorisation anyway.
1 day 31 mins
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Reference comments


2 days 8 hrs
Reference: Notificación sanitaria (autorización de comercialización)

Reference information:
ECUADOR
A partir del 21 de diciembre de 2015, por Resolución ARCSA-DE-067-2015-GGG, los alimentos procesados requieren Notificación Sanitaria en lugar de Registro Sanitario, para su distribución y comercialización en el Ecuador.
(...)
La Notificación Sanitaria de Alimentos Procesados es un certificado que permite su importación y comercialización bajo los requisitos de la normativa vigente, para garantizar que sea inocuo para el consumo humano.

https://www.controlsanitario.gob.ec/inscripcion-de-notificac...

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Efectivamente, se trata de una autorización de comercialización previa a la verificación de calidad del producto comercializado -que busca simplificar (y agilizar) la posibilidad de comercialización de determinados productos.

Notificación Sanitaria Obligatoria y su reconocimiento, como mecanismo de acceso al mercado, en lugar de Registro Sanitario;
Control posterior, que permite verificar eficazmente la calidad sanitaria de los productos en el mercado; y
Simplificación de procedimientos administrativos para facilitar el libre comercio de los productos entre los Países Miembros de la Comunidad Andina, sin que ello atente contra la calidad sanitaria de los mismos.

http://www.comunidadandina.org/Seccion.aspx?id=145&tipo=TE

Chema Nieto Castañón
Spain
Specializes in field
Native speaker of: Native in SpanishSpanish
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