We would like to inform you that on July 23, 2024, amendments to Cabinet Regulation No. 803 of 25 October 2005 "Regulations Regarding the Principles of Pricing of Medicinal Products" (hereinafter - the Amendments) were published in the Official Publisher of the Republic of Latvia, which will come into force on January 1, 2025.
According to the Amendments, from January 1, 2025, a number of changes will come into force compared to the previous procedure:
- For prescription medicinal products that are also distributed in Lithuania or Estonia, the manufacturer's price will not exceed the lowest declared price of such prescription medicinal products, excluding value added tax in the abovementioned countries. When declaring the price of the medicinal product, the manufacturer of the medicinal product (the marketing authorisation holder or its authorised representative) will confirm that the prices are in accordance with the prices in the Lithuania and Estonia.
- The manufacturer of medicinal products may increase the manufacturer's price once in a 12-month period.
- Medicines will no longer have two different wholesaler and pharmacy prices, depending on the dispensing of the medicinal products – within or outside the reimbursement system.
- For medicinal products procured in accordance with the Public Procurement Law as well as medicines included in the List of state reimbursed medicines, the price will be declared the same way as for other medicinal products.
- In cases where medicinal products have been excluded from the Medicinal Product Register of Latvia, the last notified manufacturer's price or the price offered by the seller shall be applied to the sale of the remaining stocks – whichever is the lowest.
- The medicinal product manufacturer shall inform the State Agency of Medicines of the Republic of Latvia (hereinafter – the Agency) regarding the planned changes in the manufacturer's prices of medicinal products not later than seven days prior to the application of the new manufacturer's price of medicinal products, providing justified information regarding the reasons for the increase in the prices of medicinal products.
- From 1 January 2025, the medicinal product manufacturer will be able to submit an application to the Agency for the temporary reduction of the manufacturer's price, and information on these prices will not be published in the Medicinal Product Register of Latvia.
In addition, from January 1, 2025:
The deadline for submitting information (on price changes and their reasons) to parallel distributors and parallel importers (or wholesalers) to the Agency has been changed to be the same as for manufacturers. In accordance with the other sub-paragraphs of the Amendments, changes in the formulas for the calculation of mark-ups are determined, stipulating that the previously established formulas, correction amounts and correction factors are retained for the calculation of the prices of over-the-counter medicinal products, while the procedure for calculating the prices of prescription medicinal products and the calculation of the prices of medicinal products to be prepared in a pharmacy is changed.
New Price Declaration Forms
In the future, when submitting information on the price of medicines to the Agency, we invite you to use the form and format approved by the Agency:
- Medicinal Product Pricing Structure Table (updated 28.10.2024.)
- An application to the Agency for the temporary reduction / cancellation of the manufacturer's price (new form)
The marketing authorization holder will be required to provide medicinal product price information to the Agency as before - twice a year, on the first day of each half-year (i.e., on January 1 and on July 1), as well as whenever there is a change in the manufacturer's price.
Considering that the Amendments have reduced the deadline for submitting information to the Agency, we kindly ask marketing authorisation holders and their authorised representatives to ensure timely communication with wholesalers and pharmacies about the expected price changes.
For any questions regarding the Amendments, please contact us via e-mail: info@zva.gov.lv or use the e-address. This allows us to gather information and prepare responses individually and for publication on the website.
