The procedure for regulating prices of medicines
State regulation of prices for medicines is carried out on the basis of the formation of maximum prices and markups for medicines.
Price regulation includes the following stages and (or) activities:
1. for drugs subject to wholesale and retail sale:
- registration of the price or re-registration of the registered price for the trade name of the drug for wholesale and retail sale based on reference pricing
- formation of wholesale markups
- formation of maximum prices for the trade name of the drug for wholesale sale
- formation of retail markups
- formation of maximum prices for the trade name of the drug for retail sale
- approval of maximum prices for the trade name of the drug for wholesale and retail sale
2. for drugs intended for the provision of the guaranteed volume of medical care and (or) in the compulsory medical insurance system:
- registration of the price or re-registration of the registered price for the trade name of the drug within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system
- formation of markups within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system
- formation of maximum prices for the trade name of the drug within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system
- formation of maximum prices for the international non-proprietary name of a medicine within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system
- approval of maximum prices for the trade name of a medicine within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system
- approval of maximum prices for the international non-proprietary name of a medicine within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system
The procedure for forming maximum prices and markups on medicines for wholesale and retail sales
Registration of the price or re-registration of the registered price for wholesale and retail sales for the trade name of medicines
Prices for medicines for wholesale and retail sales are registered or re-registered per consumer package, separately for each trade name, taking into account the dosage form, dosage, concentration, volume and packaging of the medicine.
To register the price or re-register the registered price for wholesale and retail sales for the trade name of medicines in the Republic of Kazakhstan, the applicant shall submit to the state expert organization an application for registration of the price or re-registration of the registered price for wholesale and retail sales (hereinafter referred to as the application) in the period up to March 10 or September 10 of the current year in the form according to Appendix 1 to these Rules. Information about the medicine in the application shall be indicated in accordance with the registration certificate for the medicine.
The maximum prices for the trade name of a medicinal product for wholesale sales are formed by adding to the registered price for wholesale and retail sales a wholesale markup differentiated based on the amount of the registered price for wholesale and retail sales per consumer package.
The maximum price for the trade name of a medicinal product for a reproduced medicinal product (generic) or a biosimilar medicinal product is formed below the average value established 3 years before the expiration of the patent protection of the maximum price for the trade name of a medicinal product of the original or biological original medicinal product:
- for a generic — not less than 30%;
- for a biosimilar medicinal product — not less than 10%.
The maximum prices for the trade name of a medicinal product for retail sales are formed by adding to the maximum price for the trade name of a medicinal product for wholesale sales a retail markup differentiated based on the amount of the maximum price for the trade name of a medicinal product for wholesale sales per consumer package.
The maximum price for the trade name of a medicinal product for a reproduced medicinal product (generic) or a biosimilar medicinal product is formed below the average value established 3 years before the expiration of the patent protection of the maximum price for the trade name of a medicinal product of an original or biological original medicinal product:
- for a generic — by 30%;
- for a biosimilar medicinal product — by 10%.
The maximum price for unregistered medicinal products when imported into the Republic of Kazakhstan on the basis of a conclusion (permit document) issued in the manner determined by the authorized body, for the prevention and (or) elimination of the consequences of emergency situations is formed and established:
- for wholesale sales by adding a wholesale markup to the import price (invoice) in accordance with the regressive scale of markups for consumer packaging;
- for retail sales — by adding to the maximum price of the trade name of the medicine for wholesale sales a retail markup in accordance with the regressive scale of markups for consumer packaging.
