18:00 Nov 7, 2014 |
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English to Russian translations [PRO] Medical - Medical: Pharmaceuticals / досье предприятия/производственного участка | |||||||
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Summary of answers provided | ||||
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4 | свидетельство поставщика |
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3 | Лицензия/разрешение на выпуск (производство и реализацию) мед. препаратов |
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Discussion entries: 1 | |
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supplier release свидетельство поставщика Explanation: заявление (декларация) поставщика с сертификатом технологии производства |
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supplier release Лицензия/разрешение на выпуск (производство и реализацию) мед. препаратов Explanation: Лицензия/разрешение на производство и реализацию мед. препаратов Скорее всего так, см. похожий документ: https://www.tga.gov.au/sites/default/files/consult-manuf-rfs... 1.2 Release for supply is considered a step in medicines manufacture, as it is specifically mentioned in the definition of manufacture in chapter 1, section 3 of the Therapeutic Goods Act 1989 (the Act), which reads: a. to produce the goods; or b. to engage in any part of the process of producing the goods or of bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process. 1.3 Each batch of finished medicinal product must be released for supply by an Authorised Person (AP) before being sold or supplied in Australia. |
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