nadere voorwaarden

19:17 Mar 4, 2012
Dutch to English translations [PRO]
Medical - Medical: Cardiology / cardiology
Dutch term or phrase: nadere voorwaarden
dossier voor uitbreiding van nadere voorwaarden van (naam medicijn).

This is part of a file that describes a cardiology drug (Dutch from Netherlands)
Ann Bishop (X)
United States
Local time: 08:30


Summary of answers provided
3 +2(instrument of) additional requirements
Lianne van de Ven
3 +2(extension of) detailed conditions
Terry Costin
Summary of reference entries provided
Instrument van de nadere voorwaarden
Lianne van de Ven

Discussion entries: 19





  

Answers


3 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
(instrument of) additional requirements


Explanation:
This would imho be a reasonable description for "nadere voorwaarden" based on the references I found.

I found one (Dutch) reference (in English) for the whole phrase "instrument of additional requirements".

Although in an environmental context, my guess is that this might be a typical Dutch instrument and way of thinking.

http://ec.europa.eu/enterprise/tris/pisa/cfcontent.cfm?vFile...



Lianne van de Ven
United States
Local time: 08:30
Native speaker of: Native in DutchDutch
PRO pts in category: 4

Peer comments on this answer (and responses from the answerer)
agree  Josephine Isaacs (X): additional requirements lijkt me goed, met een verwijzing naar de regeling misschien
6 hrs
  -> Dank je. Met je eens. Ik kan (zo gauw) geen bestaande vertalingen vinden. Op een of andere manier moet de regeling duidelijk worden.

agree  Richard Rosendal MSc
10 hrs
  -> Dankjewel
Login to enter a peer comment (or grade)
The asker has declined this answer

18 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
(extension of) detailed conditions


Explanation:

Pimecrolimus is approved (registered) for the treatment of mild to moderate atopic eczema, whereas tacrolimus is approved for the treatment of moderate to severe atopic eczema.

The indication for which both drugs are approved shows sufficient overlap to merit both agents being clustered in this GVS criterion. For the location of both agents in the treatment, this difference in the indication, is however, essential.

Making the detailed conditions for pimecrolimus and tacrolimus identical would imply moreover that for pimecrolimus reimbursement would be applicable for an unapproved indication, namely severe eczema.

For these reasons, the CVZ is of the opinion that at this point the detailed conditions of tacrolimus and pimecrolimus are not completely identical.




Terry Costin
Netherlands
Local time: 13:30
Native speaker of: English

Peer comments on this answer (and responses from the answerer)
agree  Tina Vonhof (X)
2 hrs
  -> Thank you Tina

agree  Barend van Zadelhoff: if this is about reimbursement, as the asker confirmed, then this is very likely to be the right translation. The example you offer here seems to correspond with the information in Ann's 'Okay, I just found something that may help' discussion entry
2 hrs
  -> Thank you Barend, though I'm not absolutely certain, I find the terms need to be able to fit into sentence or piece when tested from different angles

neutral  Lianne van de Ven: Klinkt goed, maar hier is nou net een Engelstalig document van CVZ waarin dit gebruikt wordt voor indicatiestellingen, niet voor vergoedingen: http://is.gd/xU2kBq //However, it's not a dr/medical but a government/insurer issue/instrument.
2 hrs
  -> I don't know Lianne but somehow requirements for me doesn't work the same way that a condition does, specific conditions seems to be directly related to reimbursement rights, I would ask a Dutch Dr with lots of English language experience if doing this
Login to enter a peer comment (or grade)
The asker has declined this answer




Reference comments


1 hr
Reference: Instrument van de nadere voorwaarden

Reference information:
"Nadere voorwaarden" is een specifiek instrument (NL overheid) om de doelmatige toepassing van medicijnen te bevorderen:
"In de Ziekenfondsverzekering kan de minister van VWS aan de
verstrekking van geneesmiddelen nadere voorwaarden
verbinden. De geneesmiddelen waarvoor dit van toepassing is,
zijn opgenomen op bijlage 2 van de Regeling farmaceutische
hulp 1996. (...)
Uit het uitgevoerde evaluatieonderzoek en andere bronnen
blijkt dat het instrument van de nadere voorwaarden een
positieve rol vervult in het huidige geneesmiddelenbeleid. Een
adequate toepassing van de nadere voorwaarden bevordert
zowel de kostenbeheersing als de kwaliteit van de
farmaceutische zorg."
http://www.cvz.nl/binaries/live/cvzinternet/hst_content/nl/d...



--------------------------------------------------
Note added at 1 hr (2012-03-04 20:35:25 GMT)
--------------------------------------------------

Vergoedings-context:
Om de doelmatige toepassing van geneesmiddelen te bevorderen worden soms nadere voorwaarden gesteld aan de aanspraak op een geneesmiddel. Deze nadere voorwaarden staan vermeld op bijlage 2 van de Regeling zorgverzekering (zie Inleiding Besluit zorgverzekering en Regeling zorgverzekering.)
http://www.fk.cvz.nl/default.asp?soort=tekst&naam=inl europe...

--------------------------------------------------
Note added at 1 day1 hr (2012-03-05 21:13:20 GMT)
--------------------------------------------------

Aanvullende referentie/Engelstalige publicatie "Dutch Assessment Procedures for the
Reimbursement of Outpatient Medicines"

Zie pag 3+4 in document
http://www.cvz.nl/binaries/live/cvzinternet/hst_content/nl/d...

The GVS
Once a medicine has been included in the GVS, it is eligible for
reimbursement. The GVS is part of the Health Insurance
Regulation and it includes lists of medicines that are insured
benefits within the framework of the Zvw. Products included in
the GVS are clustered on list 1A of the Health Insurance
Regulation or they appear separately on list 1B. A
Dutch Assessment Procedures for the Reimbursement of outpatient medicines 4
reimbursement limit is calculated for medicines on list 1A, but
there is no limit for medicines on list 1B. Furthermore,
products from lists 1A and 1B can be placed on list 2, which
means they are subject to additional conditions (for example,
eligibility for reimbursement of the product for the registered
indication is limited to a sub-population of patients – not the
entire patient population).

Pharmacotherapeutic Compass
In addition to assessing a product for inclusion in the GVS, the
CFH also advises CVZ on the place of each product compared
with other medicines within a given indication field. The
resulting CFH-advice is addressed to prescribers and is
published in the Farmacotherapeutisch Kompas [the Dutch
National Drug Formulary].

Alterations in Detailed Conditions and Reassessment
In addition to assessing medicines that have recently been
granted market permission, the assessment procedures are
also used for alterations in the inclusion of products that have
previously been assessed for the GVS.
The registrationholder’s
claim may the same, or it may actually differ from a
previous assessment. A reassessment will always require new,
published research data (see section 6, Reassessment).



--------------------------------------------------
Note added at 1 day2 hrs (2012-03-05 21:22:54 GMT)
--------------------------------------------------

OPMERKING:
Bovenstaande tekst gebruikt dus additional conditions ivm lijst 2 en <detailed conditions ivm alterations in the inclusion of products in marketingcontext.

In beide gevallen conditions, dus, waar ik het wel mee eens ben. Maar ik heb twijfels over detailed voor nadere om verwarring met lijst 2-items te vermijden, en ik zou in plaats daarvan voor additional en bij elkaar dan dus voor additional conditions (of additional requirements) kunnen kiezen.

Lianne van de Ven
United States
Native speaker of: Native in DutchDutch
PRO pts in category: 4
Note to reference poster
Asker: oh and I wish I knew what the was in English ;-) Thanks Lianne for the explanation. I have been working so long on this document that I am seeing stars...time for a break.

Login to enter a peer comment (or grade)



Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.

KudoZ™ translation help

The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.


See also:
Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search