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17:46 Jun 14, 2012 |
English to Dutch translations [PRO] Law/Patents - Law (general) / Governmental administrative/regulatory bodies (US Food and Drug Administration) | |||||||
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| Selected response from: Lianne van de Ven United States Local time: 07:15 | ||||||
Grading comment
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Summary of answers provided | ||||
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4 +2 | beschikking |
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3 +1 | toestemming |
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Discussion entries: 3 | |
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toestemming Explanation: Jack, ik weet niet of dit helpt. Een eigenaardig gebruik van "order" in "obtain an order". Naar mijn gevoel kun je het vertalen met oordeel, instructie, of gewoon toestemming. How may a manufacturer legally market a new tobacco product in the United States? "There are three regulatory pathways by which a manufacturer may legally market a new tobacco product in the United States: Submit to FDA a premarket application under section 910(c) and obtain an order authorizing marketing of the new tobacco product (section 910(c)) Submit to FDA a Substantial Equivalence Report and obtain an order finding the product to be substantially equivalent to a predicate tobacco product (section 910(a)(2)) Submit to FDA a request for an exemption from the Substantial Equivalence requirements and obtain an exemption (section 905(j)(3))" En verderop: "Once a Substantial Equivalence Report is submitted, the FDA will review it and issue either an order of substantial equivalence or an order stating that the product is not substantially equivalent. An order of substantial equivalence allows the product to be commercially marketed. A tobacco product may not be commercially marketed if you receive an order stating your product is not substantially equivalent. (section 910(a)(2))" http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndust... Dit is wellicht de brontekst: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16 and 1107 [Docket No. FDA–2010–N–0646] RIN 0910–AG39 Tobacco Products, Exemptions From Substantial Equivalence Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. http://www.gpo.gov/fdsys/pkg/FR-2011-07-05/pdf/2011-16766.pd... |
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order beschikking Explanation: dat past wel bij een instantie als de FDA, vind ik -------------------------------------------------- Note added at 3 hrs (2012-06-14 21:42:05 GMT) -------------------------------------------------- als je het mij vraagt, is het een officieel document van de FDA (230.000 googles voor "fda order"). het heeft een zekere wetskracht, en kan zowel geboden als verboden inhouden. omdat het me raadzaam lijkt steeds dezelfde vertaling te kiezen, weet ik niet of je er wel komt met vergunning of toestemming... |
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Notes to answerer
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