Sep 21, 2019 12:08
4 yrs ago
19 viewers *
Spanish term
Spain
SP/FR/CA >EN Freelancer!
Native in: English 
Works in: Spanish to English, French to English, Catalan to English
"artes" - aprobar los artes presentados
Spanish to English
Medical
Medical: Pharmaceuticals
Resolution to approve a clinical research protocol – Colombia
Hi, I'm unsure how to best translate "artes" in the sentence, "aprobar los artes presentados mediante radicado No. XXXXXXXX del XX de XX de XXXX, para el medicamento en investigación descrito en el artículo anterior"
Any ideas?
Thanks in advance!
Any ideas?
Thanks in advance!
Proposed translations
(English)
| 2 +2 | "packaging information" - approve the submitted packaging information |
Helena Chavarria
|
| 5 | approve the artwork submitted |
Giovanni Rengifo
|
Change log
Sep 21, 2019 16:08: Toni Castano changed "Level" from "Non-PRO" to "PRO"
Votes to reclassify question as PRO/non-PRO:
PRO (3): Helena Chavarria, Robert Carter, Toni Castano
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Proposed translations
+2
2 hrs
Helena Chavarria
Spain
Spain
Native in English
Spain
Striving for excellence
Native in: English (Variant: British) 
Works in: Spanish to English, Catalan to English
Related KudoZ points
:
84
Selected
"packaging information" - approve the submitted packaging information
CAMBIO DE ARTES DEL PRODUCTO (ENVASE, ESTUCHE, FOLLETO CUANDO CORRESPONDA) SOLICITUD DE MODIFICACIÓN A LA NOTIFICACIÓN SANITARIA OBLIGATORIA DE PRODUCTOS COSMÉTICOS (NACIONAL, IMPORTADO)
http://www.sacs.gob.ve/site/images/requisitos/DMC/CAMBIO DE ...
Page 81
9. Artes material envase y empaque
http://servicios.procomer.go.cr/aplicacion/civ/documentos/Se...
Page 38
Revisada la documentación allegada, la Sala Especializada de Medicamentos y Productos Biológicos de la Comisión Revisora recomienda aprobar la información farmacológica para inclusión en las artes del producto de la referencia.
https://www.invima.gov.co/documents/20143/1266673/ACTA_No._6...
I 'think' it might refer to the information included on the labels and pacakages of products.
--------------------------------------------------
Note added at 3 hrs (2019-09-21 15:15:20 GMT)
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Page 3
ARTÍCULO SEGUNDO: APROBAR como único diseño los artes material de envase y empaque allegados mediante radicados No. 2014158368 del 01/12/2014 y No. 2014163265 del 10/12/2014 los cuales deberán ajustar sus textos de acuerdo a lo dispuesto en la presente Resolución y el Artículo 72 y 74 del Decreto 677 de 1995, y en los cuales debe incluir el número del Registro Sanitario otorgado en la presente Resolución.
http://web.sivicos.gov.co/registros/pdf/1337588_2015033342.p...
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:
Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.
https://www.fda.gov/drugs/types-applications/new-drug-applic...
* Sorry: pacakages = packages
--------------------------------------------------
Note added at 3 hrs (2019-09-21 15:25:29 GMT)
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Page 15
El interesado solicita a la Sala Especializada de Medicamentos y Productos Biológicos de la Comisión Revisora conceptuar sobre los siguientes beneficios incluidos en las artes de algunos productos que se encuentran en el mercado:
- Magnesio: Necesario para ayudar a fortalecer huesos y dientes
- Zinc, Cobre y Manganeso: Esencial para el crecimiento, desarrollo y reparación del esqueleto.
- Boro: Ayuda a una mejor utilización del calcio
https://www.invima.gov.co/documents/20143/1266653/Acta No. 0...
Product Labeling and Advertising
Prescription drug labeling, also known as the package insert, package circular, or prescribing information, is the primary mechanism through which the FDA and drug manufacturers communicate essential, science-based prescribing information to healthcare professionals. Labeling provisions contained in 21 CFR §§201.57 and 201.56 require that prescribing information must summarize the essential information on the safe and effective use of the product; that information contained in the labeling must be accurate and not false and misleading; and that there must be no implied claims or suggestions for use if evidence of safety or effectiveness is lacking.32 Whenever possible, data contained in labeling should be derived from human experience. In the United States, the FDA regulates the format and content of labels for product containers, cartons, and the package insert that accompanies the product.
https://www.sciencedirect.com/topics/pharmacology-toxicology...
product information
Documents providing officially approved information for healthcare professionals and patients on a medicine. The product information includes the summary of product characteristics, package leaflet and labelling.
More information can be found under 'Product-information requirements'.
https://www.ema.europa.eu/en/glossary/product-information
'Product information' is another possibility.
--------------------------------------------------
Note added at 3 hrs (2019-09-21 15:34:05 GMT)
--------------------------------------------------
https://www.pharmaceuticalonline.com/doc/new-regulations-and...
http://www.sacs.gob.ve/site/images/requisitos/DMC/CAMBIO DE ...
Page 81
9. Artes material envase y empaque
http://servicios.procomer.go.cr/aplicacion/civ/documentos/Se...
Page 38
Revisada la documentación allegada, la Sala Especializada de Medicamentos y Productos Biológicos de la Comisión Revisora recomienda aprobar la información farmacológica para inclusión en las artes del producto de la referencia.
https://www.invima.gov.co/documents/20143/1266673/ACTA_No._6...
I 'think' it might refer to the information included on the labels and pacakages of products.
--------------------------------------------------
Note added at 3 hrs (2019-09-21 15:15:20 GMT)
--------------------------------------------------
Page 3
ARTÍCULO SEGUNDO: APROBAR como único diseño los artes material de envase y empaque allegados mediante radicados No. 2014158368 del 01/12/2014 y No. 2014163265 del 10/12/2014 los cuales deberán ajustar sus textos de acuerdo a lo dispuesto en la presente Resolución y el Artículo 72 y 74 del Decreto 677 de 1995, y en los cuales debe incluir el número del Registro Sanitario otorgado en la presente Resolución.
http://web.sivicos.gov.co/registros/pdf/1337588_2015033342.p...
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:
Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.
https://www.fda.gov/drugs/types-applications/new-drug-applic...
* Sorry: pacakages = packages
--------------------------------------------------
Note added at 3 hrs (2019-09-21 15:25:29 GMT)
--------------------------------------------------
Page 15
El interesado solicita a la Sala Especializada de Medicamentos y Productos Biológicos de la Comisión Revisora conceptuar sobre los siguientes beneficios incluidos en las artes de algunos productos que se encuentran en el mercado:
- Magnesio: Necesario para ayudar a fortalecer huesos y dientes
- Zinc, Cobre y Manganeso: Esencial para el crecimiento, desarrollo y reparación del esqueleto.
- Boro: Ayuda a una mejor utilización del calcio
https://www.invima.gov.co/documents/20143/1266653/Acta No. 0...
Product Labeling and Advertising
Prescription drug labeling, also known as the package insert, package circular, or prescribing information, is the primary mechanism through which the FDA and drug manufacturers communicate essential, science-based prescribing information to healthcare professionals. Labeling provisions contained in 21 CFR §§201.57 and 201.56 require that prescribing information must summarize the essential information on the safe and effective use of the product; that information contained in the labeling must be accurate and not false and misleading; and that there must be no implied claims or suggestions for use if evidence of safety or effectiveness is lacking.32 Whenever possible, data contained in labeling should be derived from human experience. In the United States, the FDA regulates the format and content of labels for product containers, cartons, and the package insert that accompanies the product.
https://www.sciencedirect.com/topics/pharmacology-toxicology...
product information
Documents providing officially approved information for healthcare professionals and patients on a medicine. The product information includes the summary of product characteristics, package leaflet and labelling.
More information can be found under 'Product-information requirements'.
https://www.ema.europa.eu/en/glossary/product-information
'Product information' is another possibility.
--------------------------------------------------
Note added at 3 hrs (2019-09-21 15:34:05 GMT)
--------------------------------------------------
https://www.pharmaceuticalonline.com/doc/new-regulations-and...
Peer comment(s):
| agree |
Robert Carter
: Good call, Helena, that makes a lot of sense.//Actually, I think I would just go with "labeling" here, that's what it's called in English, per your references.
1 hr
|
|
It seems a strange term to use though. Thank you, Robert :-) //It was one of those questions that involved finding pieces and putting them together! I think you're right, 'labelling' is fine.//Does labelling include the 'folleto'?
|
|
| agree |
marideoba
17 days
|
|
Thank you very much :-)
|
4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
14 hrs
Giovanni Rengifo
Colombia
Colombia
Native in Spanish
Works in field
Colombia
Traductores Oficiales Cali
Native in: Spanish
Works in: Spanish to English, English to Spanish, German to Spanish, and 2 more.
Related KudoZ points
:
113
Spanish term (edited):
aprobar los artes presentados
approve the artwork submitted
-
Peer comment(s):
| neutral |
Robert Carter
: It's not about how the information looks, but rather what it contains. See Helena's references. ¡Saludos!//The problem is, in English, "artwork" is a design concept, and it's not about that. The correct term here would be "labeling".
2 hrs
|
|
I'm from Colombia, so I'm 100% sure they're not referring to "packaging information" in general. "artes" means "artwork" in this case. It's a preliminary design submitted for approval. It includes layout, colors, font type, etc./ I completely disagree.
|
|
| agree |
abe(L)solano
: La verdad no es claro a primera vista, pero en los documentos colombianos mencionan "artes", "etiquetado" e "inserto" por separado.
2 days 11 hrs
|
| disagree |
marideoba
: I, as Robert explained above, completely disagree.
16 days
|
Discussion
What some Peruvians linguists say about this:
http://udep.edu.pe/castellanoactual/es-el-arte-o-la-arte-per...