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Exceptional procedure in notices of withdrawal regarding reimbursable medicinal products

Announcement to marketing authorisation holders

Based on the amendment of the Health Insurance Act that enters into force on 1 January 2025 (given 19 December 2024) the confirmed reasonable wholesale prices of reimbursable medicinal products authorised in 2010 and thereafter will be reduced by 1.5 per cent on 1 March 2025. The reduction in wholesale prices does not apply to biological medicinal products belonging to a reference price group based on a biosimilar product or to parallel-imported medicinal products, when a reimbursable direct-imported medicinal product is not in the wholesale price reduction procedure. The reduction in wholesale prices does not apply to the maximum wholesale prices of medicinal products belonging to a reference price group based on a generic product in the reference price system either.

In the Act the marketing authorisation holders are provided with an opportunity to withdraw medicinal products from the reimbursement system exceptionally also as from 1 March 2025.

If the marketing authorisation holders do not want that their product is covered by the reimbursement system with the reduced wholesale price as from 1 March 2025, the marketing authorisation holder can withdraw the product from the reimbursement system by notifying the Pharmaceuticals Pricing Board thereof no later than Tuesday 7 January 2025.

The notification must be made in writing. The notification can be sent by email to hila.stm(at)gov.fi.

The products to be withdrawn must be specified clearly. The notification must include at least the following information on the medicinal products to be withdrawn:

  • name, strength, pharmaceutical form and package size of the product,
  • VNR number (Nordic product number),
  • holder of the marketing authorisation and
  • number of the marketing authorisation.

The Pharmaceuticals Pricing Board will publish at its website in January 2025 an announcement of the products withdrawn from the reimbursement system.

In regard to the price reduction that will be effected in March 2025 the Pharmaceuticals Pricing Board will send in January a separate official letter of hearing to the marketing authorisation holders concerned.

Further information
Reima Palonen, Director, tel +358 295 163 090 (out of office 27 December 2024 – 2 January 2025)
Ulla Kurkijärvi, Principal Pharmaceutical Officer, tel. +358 295 163 436
E-mail firstname.lastname@gov.fi