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Home / Medicines / Marketing authorisation of pharmaceuticals / Variations

Variations

Variations to MRP/DCP marketing authorisations

  • Information for marketing authorisation holder
  • Overview of issuance of decisions/notifications for MRP variations

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Variations to national marketing authorisations

  • Information for marketing authorisation holder

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Payments for marketing authorisation variations

  • Amendment to the Reimbursement Decree effective as of 1 June 2019
  • Amendment to the reimbursement decree – payments for marketing authorisation variations effective as of 15 October 2013
  • Payments for variations submitted before the effective date of the reimbursement decree (effective as of 15 October 2013)

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