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Medical - Medical: Health Care | | English term or phrase: relabeler | Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment.
Definitions of Establishment Activities
Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name. |
| Rina-chanKudoZ activityQuestions: 85 (none open) ( 4 closed without grading) Answers: 0
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| | Russian translation:предприятие заменяющее информацию о лекарстве, | Explanation:
Предприятие заменяющее информацию о продукте, сопровождающую этот продукт, в соответствии с требованиями данной страны (имеется в виду продукт произведенный в другой стране с другими требованиями к информации о продукте, содержащейся на упаковке и внутри упаковки), в том числе инструкцию по применению. Label - здесь, не этикетка.
Section 201(m) defines 'labeling' as:
'all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or
(2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
Такая деятельность вполне законна и даже требуется законом, и не имеет ничего общего с контрафактом, когда заменяется этикетка с именем производителя.
Both relabelers and repackagers need to meet the GMP requirements stated in the ICH-Q7 guidelines (which can be downloaded from http://www.ich.org/cache/compo/276-254-1.html) - see section 17
Also both relabelers and repackagers selling product in the USA need to register their facilities and the products they repack/relabel with FDA through FDA's Electronic Submission Gateway (ESG).
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| Selected response from:
Pavel Venediktov
Russian Federation
Local time: 02:48
| Grading comment Thanks
4 KudoZ points were awarded for this answer |
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| Discussion entries: 0 |
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Automatic update in 00:
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28 mins confidence:  
4 hrs confidence: peer agreement (net): +1 предприятие заменяющее информацию о лекарстве,
Explanation:
Предприятие заменяющее информацию о продукте, сопровождающую этот продукт, в соответствии с требованиями данной страны (имеется в виду продукт произведенный в другой стране с другими требованиями к информации о продукте, содержащейся на упаковке и внутри упаковки), в том числе инструкцию по применению. Label - здесь, не этикетка.
Section 201(m) defines 'labeling' as:
'all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or
(2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
Такая деятельность вполне законна и даже требуется законом, и не имеет ничего общего с контрафактом, когда заменяется этикетка с именем производителя.
Both relabelers and repackagers need to meet the GMP requirements stated in the ICH-Q7 guidelines (which can be downloaded from http://www.ich.org/cache/compo/276-254-1.html) - see section 17
Also both relabelers and repackagers selling product in the USA need to register their facilities and the products they repack/relabel with FDA through FDA's Electronic Submission Gateway (ESG).
| Pavel Venediktov
Russian Federation
Local time: 02:48
Native speaker of:  Russian
PRO pts in category: 54
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