Glossary entry (derived from question below)
English term or phrase:
order (in this context)
Dutch translation:
beschikking, besluit, toestemming, vergunning
Added to glossary by
Jack den Haan
Jun 14, 2012 17:46
12 yrs ago
1 viewer *
English term
order (in this context)
English to Dutch
Law/Patents
Law (general)
Governmental administrative/regulatory bodies (US Food and Drug Administration)
"In general, a tobacco product manufacturer must obtain an order under section 910(c)(1)(A)(i) (order after review of a premarket application) before the manufacturer may introduce a new tobacco product (see definition in Section III below) into interstate commerce (section 910 of the Act; 21 USC 387j). An order under section 910(c)(1)(A)(i) is not required, however, if a manufacturer submits a report under section 905(j) for the new tobacco product and FDA issues an order finding that the tobacco product is (1) substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007, and (2) in compliance with the requirements of the Act."
The term 'order' occurs repeatedly in the document. I've translated it tentatively as 'bevel' but am not quite happy with that. In the context above, for example, the appropriate term sounds more like 'vergunning'. But that may be a brdige too far. 'Bevelschrift' perhaps? Any help greatly appreciated!
The term 'order' occurs repeatedly in the document. I've translated it tentatively as 'bevel' but am not quite happy with that. In the context above, for example, the appropriate term sounds more like 'vergunning'. But that may be a brdige too far. 'Bevelschrift' perhaps? Any help greatly appreciated!
Proposed translations
(Dutch)
3 +1 | toestemming | Lianne van de Ven |
4 +2 | beschikking | Ron Willems |
Change log
Jun 15, 2012 17:51: Jack den Haan Created KOG entry
Proposed translations
+1
52 mins
Selected
toestemming
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...
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...
Note from asker:
Ontzettend bedankt voor je uitvoerig antwoord, Lianne. Dit is precies wat ik zelf dacht, hoewel ik dat hierboven heb verwoord met 'vergunning'. Op de meeste plaatsen in het document denk ik dat de suggestie van Ron goed te gebruiken is, maar soms dus niet. Context is everything. Ik voel me gesterkt om in voorkomende gevallen jouw oplossing te gebruiken. Nogmaals bedankt! |
PS: Nee, het document dat je noemde was niet de brontekst, maar je zat er dichtbij! (Guidance for Industry and FDA Staff, Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; OMB Control No. 0910-0673). |
Peer comment(s):
agree |
freekfluweel
: erkenning/registratie http://www.vwa.nl/onderwerpen/werkwijze-food/dossier/erkenni...
13 hrs
|
4 KudoZ points awarded for this answer.
Comment: "Bedankt!"
+2
28 mins
English term (edited):
order
beschikking
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...
--------------------------------------------------
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...
Note from asker:
Bedankt Ron. Dit is natuurlijk veel beter dan die bevelachtige toestanden. Soms vraagt de context volgens mij echter een term die meer in sfeer van toestemming (zie Lianne) of vergunning ligt. Op andere plaatsen is 'beschikking' volgens mij weer de aangewezen term. Vertalen kan lastig zijn :-) |
Peer comment(s):
agree |
Lianne van de Ven
: Hier ben ik het ook mee eens, gewoon besluit...
26 mins
|
merci. de FDA vaardigt aan de lopende band 'orders' uit, overigens.
|
|
agree |
Tina Vonhof (X)
20 hrs
|
dank je wel
|
Discussion