The fees charged for applications changed as of 1 january 2009

- The Pharmaceuticals Pricing Board has updated the application forms and instructions
The Ministry of Social Affairs and Health has issued a new Decree on the Pharmaceuticals Pricing Board’s performances subject to a charge. The Decree enters into force on 1 January 2009. The fees charged for the performances of the Board are determined on the basis of the Act on Charges Payable to the State.  

The structure of the Decree has been revised and the fees have been adjusted according to the new estimates of the amount of work related to the applications. Furthermore, the Decree takes into account the reference price system to be applied as of 1 April 2009.

The structure of the Decree is divided according to the type of preparation into preparations subject to marketing authorization, clinical nutritional preparations, basic ointments and preparations subject to special authorization. The points regarding the fees charged for applications for basic and special reimbursement status have been combined. Separate fees are no more charged by item for the further forms of medicinal products or preparations and strengths that are applied for at the same time. In the future the fees concerned are included in the fee for each application point. As new types of application the Decree includes, among others, biosimilar preparations and an application for reimbursement within the reference price system. Furthermore, the Decree includes a fee to be charged for a notification of reference price according to package.

The application forms have been updated to correspond to the new Decree of the Ministry of Social Affairs and Health on the Pharmaceuticals Pricing Board’s performances subject to a charge.

The most significant amendments to the application instructions concern submitting application material. As regards the applications drawn up by companies the application material has to be sent to the Pharmaceuticals Pricing Board both in two paper copies and stored on cd-rom or USB download key. The amendment is based on the new ADP system introduced at the Pharmaceuticals Pricing Board on 1 December 2008. In the new system the applications for reimbursement and wholesale price and documents relating to them are processed electronically, and within the next few years the Board will wholly switch to using electronic processing and filing of applications.

The new application forms and instructions will be available at the Pharmaceuticals Pricing Board’s website ( www.hila.fi ).

The Pharmaceuticals Pricing Board will arrange training for the holders of marketing authorization on 13 and 22 January 2009. The new Decree on fees will be dealt with as well.    

For further information contact
Pharmaceutical Officer Hanna-Kaisa Joutsen, tel. +358 9 160 74940,
Chief Pharmaceutical Officer Ulla Kurkijärvi, tel. +358 9 160 73173 and
Chief Pharmaceutical Officer Mareena Paldán, tel. +358 9 160 74497