Authorised medicinal product – parallel-imported and parallel-distributed product

These instructions apply when the marketing authorisation holder applies for the following for a parallel-imported or a parallel-distributed product:

• reimbursement status and a reasonable wholesale price for the first time, and the reimbursement status is sought to the same extent as has been approved for a similar product
• extension of reimbursement status to the same extent as has been approved for a similar product
• renewal of reimbursement status and wholesale price

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

• You can indicate the reimbursement status you are applying for as follows: The reimbursement status is sought to the same extent as has been approved for a directly imported product.
• 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)
• Name the files as follows:
  • Summary of product characteristics
  • Marketing authorisation decision

This page was updated on 25 March 2026.