Application for reimbursement of nutritional products from the Regional Council

Updated 20 December 2018

The Danish Medicines Agency authorises nutritional products eligible for reimbursement from the Regional Council.

Companies that want a product to be included on the Danish Medicines Agency’s lists of reimbursable nutritional products should send a fully completed application form and any relevant documentation as well as pay a fee to the Danish Medicines Agency.

Moreover, the nutritional product must be notified to the Danish Veterinary and Food Administration according to the rules on food products for special medical purposes. Read the Danish Veterinary and Food Administration’s guideline on notification (in Danish).

The majority of applications are presented to the members of the Danish Medicines Agency’s Authorisation Panel who meet four times a year. Please send your application no later than one month before the meeting at which you want us to assess your application.

Authorisation Panel

The Authorisation Panel consists of experts in clinical nutrition, who advise the Danish Medicines Agency on matters regarding reimbursement for nutritional products.

The panel consists of the following members until the end of 2019:

  • Gitte Zachariassen, PhD, specialist in neonatology
  • Helle Skandorff Vestergaard, MSc in clinical nutrition and clinical dietician
  • Jette Lind Thomsen Fabricius, clinical dietician
  • Kirsten Skamstrup Hansen, PhD, specialist in allergology
  • Mette Borre, clinical dietician
  • Rudolf Albert Scheller, specialist in internal medicine and geriatrics
  • Porntiva Poorisrisak, Ph.D., specialist in paediatrics
  • Bente Utoft Andreassen, Ph.D., specialist in paediatrics and paediatric gastroenterology

Future meeting dates of the Authorisation Panel

27 February 2019: Deadline for applications is 27 January 2019

4 June 2019: Deadline for applications is 4 May 2019

29 August 2019: Deadline for applications is 29 July 2019

25 November 2019: Deadline for applications is 25 October 2019

1) Application form and documentation

Please send the application form and any appendices by email to medicintilskud@dkma.dk

In the subject field, please write ”product name – application for reimbursement for nutritional product”.

In addition to the application form, please send the following documents:

  • Product data sheet and labelling
  • Information on the amino acid and fatty acid profiles as well as the carbohydrate composition
  • Clinical documentation in the form of original scientific articles. Please highlight any matters of special interest
  • A copy of the notification and the receipt from the Danish Veterinary and Food Administration showing that the product has been notified according to the rules on food products for special medical purposes

2) Payment of fee

A fee of DKK 4,350 is payable for:

  • a new product
  • notification of changed composition of a product that has been granted reimbursement

A fee of DKK 1,100 is payable for:

  • other flavours in connection with an application for reimbursement for a new product
  • a new flavour of a product that has been granted reimbursement
  • an identical product marketed under another name

The fee should be paid into the Danish Medicines Agency’s account with Danske Bank 0216-4069069193
(SWIFT: DABADKKK - IBAN: 7702164069069193) marked ”EP-præparatnavn”.

We will begin the assessment when we have received the fee.

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