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21:50 Sep 11, 2018 |
Spanish to English translations [PRO] Medical - Medical: Pharmaceuticals / Regulaciones | |||||||
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| Selected response from: Robert Carter Mexico Local time: 14:42 | ||||||
Grading comment
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Summary of answers provided | ||||
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3 +2 | grandfathering authorization |
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4 | authorization to use up (product, labelling material, packaging) |
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Summary of reference entries provided | |||
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marketing authorisation |
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authorization to use up (product, labelling material, packaging) Explanation: (to) use up = agotar |
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grandfathering authorization Explanation: I can't find a specific reference to the term "grandfathering authorization" in this context, but grandfathering is the term for products already in the supply chain at the time new legislation enters into force regarding packaging requirements, etc. The US Government uses the term "grandfathering exemption", but perhaps the term "grandfathering authorization" or "product grandfathering authorization" would better explain the situation we have here, plus it differentiates it from US policy usage. According to the ‘Grandfathering Policy’ guidance document, medical products that are packaged without a traceable product identifying 2D barcode before the DSCSA deadline of 27 November 2018, but are in the supply chain after that date, can continue to be distributed. https://www.securingindustry.com/pharmaceuticals/fda-publish... A package or homogenous case of product that is not labeled with a product identifier shall be exempted from certain requirements in section 582 (i.e., grandfathered) where there is documentation that it was packaged by a manufacturer before November 27, 2018. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula... |
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Grading comment
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2 hrs |
Reference: marketing authorisation Reference information: autorização de introdução no mercado de um medicamento which marketing authorisations have already been granted - https://ec.europa.eu/health/sites/health/files/files/eudrale... [...] the marketing authorisation holder for an immunological veterinary medicinal product https://www.linguee.com/portuguese-english/translation/medic... |
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