aanvaarden
English translation: approve
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| 13:53 Oct 20, 2015 |
| Dutch to English translations [PRO] General / Conversation / Greetings / Letters | |||||||
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|  Selected response from: Barend van Zadelhoff Netherlands Local time: 10:58 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 4 +1 | approve |
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| 3 | submitted and accepted |
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| Discussion entries: 5 | |
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Answers
2 hrs confidence: 
submitted and accepted Explanation: I would add the somewhat redundant 'submitted' to make ir clear what is going on: the docs have been accepted as 'received' rather than 'agreed with' |
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3 days 15 hrs confidence: peer agreement (net): +1
peer agreement (net): +1approve Explanation: Bij deze vergunning voor het in de handel brengen (VHB) worden de bijsluiterteksten gevoegd, zoals die bij de aanvraag tot vergunning werden aanvaard. http://tinyurl.com/nbmoky4 They may mean by "bijsluiterteksten" all product information, as the plural is used. A product has just one patient information leaflet/package leaflet (bijsluiter). They probably mean by 'bijsluiterteksten' = de teksten die worden bijgesloten/de bij te sluiten teksten', that is: summary of product characteristics (SmPC), package leaflet/patient information leaflet (PIL) and labeling. Just to indicate the idea: Bij deze vergunning voor het in de handel brengen (VHB) worden de bijsluiterteksten gevoegd, zoals die bij de aanvraag tot vergunning werden aanvaard. The product information texts [summary of product characteristics, package leaflet and labeling] will be added to this marketing authorization as approved during the marketing authorization application procedure [MAA procedure]. These texts are heavily revised during the procedure until a final version is approved. MA - marketing authorization - vergunning voor het in de handel brengen After the first marketing authorization in the Community is granted, the marketing authorization holder may request one or more Member State(s) to recognize an authorization approved by the reference Member State, by submitting an application in accordance with Article 28 of Directive 2001/83/EC(12). Within 90 days of receipt of a valid application, the reference Member State will provide the assessment report together with the approved summary of product characteristics, labeling and package leaflet to the concerned Member States and to the marketing authorization holder(13). Within 90 days of the receipt of these documents, the concerned Member States shall recognize the decision of the reference Member State and the approved summary of product characteristics, package leaflet and labeling by granting a MA. https://pharmupdates.wordpress.com/2013/05/10/drug-authoriza... Another example: 'the summary of the product characteristics' in relation to a medicinal product means: (b) where the product has an EU marketing authorisation, the summary of the product characteristics: (i) as approved by the European Commission in granting the authorisation, or (ii) where the summary has been varied since that approval, as so amended; http://tinyurl.com/omn82qx |
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