order (in this context)

Dutch translation: beschikking, besluit, toestemming, vergunning

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:order (in this context)
Dutch translation:beschikking, besluit, toestemming, vergunning
Entered by: Jack den Haan

17:46 Jun 14, 2012
English to Dutch translations [PRO]
Law/Patents - Law (general) / Governmental administrative/regulatory bodies (US Food and Drug Administration)
English term or phrase: order (in this context)
"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!
Jack den Haan
Netherlands
Local time: 13:15
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...

Selected response from:

Lianne van de Ven
United States
Local time: 07:15
Grading comment
Bedankt!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2beschikking
Ron Willems
3 +1toestemming
Lianne van de Ven


Discussion entries: 3





  

Answers


52 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
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...



Lianne van de Ven
United States
Local time: 07:15
Native speaker of: Native in DutchDutch
PRO pts in category: 69
Grading comment
Bedankt!
Notes to answerer
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!

Asker: 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 comments on this answer (and responses from the answerer)
agree  freekfluweel: erkenning/registratie http://www.vwa.nl/onderwerpen/werkwijze-food/dossier/erkenni...
13 hrs
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28 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
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...

Ron Willems
Netherlands
Local time: 13:15
Specializes in field
Native speaker of: Native in DutchDutch
PRO pts in category: 262
Notes to answerer
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 comments on this answer (and responses from the answerer)
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
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