Authorised medicinal product – product in the reference price system

These instructions apply when the marketing authorisation holder applies for reimbursement status for a medicinal product in the reference price system at most to the same extent as has been approved for other products in the same reference price group and the reference price group is based on a generic product.

If you are applying for different reimbursement statuses for different packages of the same medicinal product and/or their therapeutic indications differ from each other, the indications and the reimbursement status you are applying for must be separately detailed for each package.

See also the general instructions for the application at applying for reimbursement status and reasonable wholesale price.

Application documents

• Attach the following documents to your application:
  • valid summary of product characteristics
  • valid marketing authorisation decision (if the marketing authorisation was granted in a centralised authorisation procedure, also attach the information published by the European Medicines Agency on the different product packages and their marketing authorisation numbers)
  • any other information (such as grounds for the proposed price)
• Name the files as follows:
  • Summary of product characteristics
  • Marketing authorisation decision
  • Name other attachments appropriately, for example: Grounds for proposed price

This page was updated on 25 March 2026.