The State Agency of Medicines publicly available paid service pricelist has been approved

The State Agency of Medicines publicly available paid service pricelist has been approved

On 14th February 2013 the Cabinet of Ministers Regulation No. 75 “The State Agency of Medicines Publicly Available Paid Service Pricelist” of 29th January 2013 (hereinafter - Regulation) came into force determining the paid services provided by the State Agency of Medicines (hereinafter - Agency) and the payment procedure.

The Regulation determines the procedure of making payment for the additional services provided by the State Agency of Medicines.

To encourage marketing authorisation holders to enter the market of medicinal products in Latvia by authorising new medicines the Regulation entails decreased prices for the following services regarding marketing authorisation of medicines:

• expertise on application and additional documentation for marketing authorisation of medicines in the national procedure for the first submitted dosage form
  • with a new active substance - 60%;
  • with a known active substance, fixed combination (new medicines containing at least two active substances where the combination has not been previously authorised as a fixed combination medicinal product), similar biological medicinal products or medicines with well-established medicinal use - 25%;
• expertise on application and additional documentation for marketing authorisation renewal in the national procedure for single dosage form - price decrease by 25%; for each additional dosage form - 20%;
• expertise on a periodic safety update report of nationally authorised medicines for medicines containing the same active substance or the same active substances for one marketing authorisation holder - 70%.

Several new paid service positions have been introduced in the Regulation that include review of application for approval of the site (address) of pharmaceutical activity submitted by the merchant, evaluation of compliance of the site for use of tissues, cells, organs and dead human bodies for implementation of medical studies program in a higher education institution, issuing of permit (certificate) duplicate for the corresponding health care institution or higher education institution, as well as issuing of the electronic edition of the official Drug Register of the Republic of Latvia containing summary of product characteristics and package leaflets of medicines. The Regulation also specifies paid service positions and prices regarding change of legal address of the merchant or change of the address of the pharmaceutical activity company, changes in the special permit (licence) for pharmaceutical activity (including expiration date) and its annexes, if evaluation of compliance of the pharmaceutical activity company is not necessary, as well as regarding costs of the official edition of the Drug Register of the Republic of Latvia.

The new Regulation replaces the 17th January 2006 Cabinet of Ministers Regulation No. 61 “Regulation Regarding the State Agency of Medicines Publicly Available Paid Service Pricelist”.

The full text of the 29th January 2013 Cabinet of Ministers Regulation No. 75 “The State Agency of Medicines Publicly Available Paid Service Pricelist” is available here (PDF file).