Glossary entry (derived from question below)
Dutch term or phrase:
aanvaarden
English translation:
approve
Added to glossary by
Barend van Zadelhoff
Oct 20, 2015 13:53
8 yrs ago
2 viewers *
Dutch term
aanvaarden
Dutch to English
Other
General / Conversation / Greetings / Letters
Bijsluiterteksten worden hiermee gevoegd, zoals die bij de aanvraag tot vergunning werden aanvaard.
I know "aanvaarden" can mean "accept" or "receive" but because texts are attached, can I assume it's "received" and not "accepted" here.
Giving: Texts of product leaflets are attached, as they were received as part of the application.
Context: cosmetic product being approved in Belgium.
Thanks in advance!
I know "aanvaarden" can mean "accept" or "receive" but because texts are attached, can I assume it's "received" and not "accepted" here.
Giving: Texts of product leaflets are attached, as they were received as part of the application.
Context: cosmetic product being approved in Belgium.
Thanks in advance!
Proposed translations
(English)
| 4 +1 | approve |
Barend van Zadelhoff
|
| 3 | submitted and accepted |
Richard Purdom
|
Change log
Oct 25, 2015 19:53: Barend van Zadelhoff Created KOG entry
Proposed translations
+1
3 days 15 hrs
Barend van Zadelhoff
Netherlands
Netherlands
Native in Dutch
Netherlands
TR is the most intimate act of reading.
Native in: Dutch 
Works in: English to Dutch, Dutch to English, Dutch
Related KudoZ points
:
89
Selected
approve
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
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
Peer comment(s):
| agree |
Kitty Brussaard
: A well-documented answer, to say the least.
1 day 18 hrs
|
|
Dank je. Dit is wat mij ervan bijstond. Ik heb er wat evidence bij gezocht.
|
4 KudoZ points awarded for this answer.
2 hrs
submitted and accepted
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'
Discussion
'aanvaard' may mean 'goedgekeurd' as well --> 'approved'
Example:
Statutory information: a QR code may provide patients/users with readily available information extracted from the approved package leaflet, the approved summary of products characteristics (SmPC) and/or the approved additional risk minimisation measures as outlined in the Risk management plan (i.e. educational material).
http://www.ema.europa.eu/docs/en_GB/document_library/Regulat...