"artes" - aprobar los artes presentados
English translation: "packaging information" - approve the submitted packaging information
| 12:08 Sep 21, 2019 |
| Spanish to English translations [PRO] Medical - Medical: Pharmaceuticals / Resolution to approve a clinical research protocol – Colombia | |||||||
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|  Selected response from: Helena Chavarria Spain Local time: 04:20 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 5 | approve the artwork submitted |
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| 2 +2 | "packaging information" - approve the submitted packaging information |
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| Discussion entries: 5 | |
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Answers
2 hrs confidence: 
peer agreement (net): +2
peer agreement (net): +2"packaging information" - approve the submitted packaging information Explanation: 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) -------------------------------------------------- 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... |
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Grading comment
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14 hrs confidence:
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