The pharmaceutical industry of Kazakhstan has faced a number of serious problems related to the transition to new rules for registering medicines within the EAEU, the press service of Atameken reports. In particular, representatives of the NCE RK state that the translation of registration certificates (RC) according to the requirements of the EAEU may lead to disruptions in ensuring the availability of medicines to the population of Kazakhstan.
The essence of the problem is that from January 1, 2026, the validity of national RUs of medicines will be cancelled and only RUs of the EAEU will be valid. As of November of this year, only 861 (19.2%) applications for compliance with the EAEU rules have been submitted.
The low number of applications for bringing the RK RU into compliance with the EAEU RU is due to the imperfection of the current regulatory legal acts, which lead to the fact that drugs with the EAEU RU cannot be purchased within the framework of state procurement, and also cannot be sold in the commercial segment, due to the lack of an approved price.
“Thus, the cessation of sales of just one type of medicine can lead to losses of up to 460 million tenge,” notes the managing director and director of the medical services department of NPP Nazgul Kabdrakhmanova.
Due to the urgency of the problem and its scale, the NCE proposed several key measures to mitigate the consequences of the transition to the EAEU RU. This is the automatic preservation of maximum prices for drugs transferred to the EAEU RU in order to ensure their availability on the market and avoid losses for manufacturers. It is also necessary to review approaches to the formation of the Kazakhstan National Drug Formulary (KNF). It is necessary to take into account the data of the Unified Register of Registered Medicines of the EAEU when forming the National Drug Formulary of Kazakhstan so that drugs of domestic manufacturers with the EAEU RU can be included in the drug procurement lists.
By the way, as representatives of the Committee for Medical and Pharmaceutical Control of the Ministry of Health stated at the meeting, the problems raised by the NPP are extremely urgent and will be taken into account in order to maintain access to medicines for the population of Kazakhstan.
In order to ensure timely and uninterrupted provision of medicines to the population, it is important to quickly respond to today's problems in the pharmaceutical industry. The NCE RK calls on the state body to take measures to eliminate barriers in regulatory acts in order to avoid economic losses and ensure the availability of vital drugs. It is important that all stakeholders, including representatives of the pharmaceutical industry, the Ministry of Health and other regulatory bodies, work together to promptly resolve the problems that have arisen.
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
The essence of the problem is that from January 1, 2026, the validity of national RUs of medicines will be cancelled and only RUs of the EAEU will be valid. As of November of this year, only 861 (19.2%) applications for compliance with the EAEU rules have been submitted.
The low number of applications for bringing the RK RU into compliance with the EAEU RU is due to the imperfection of the current regulatory legal acts, which lead to the fact that drugs with the EAEU RU cannot be purchased within the framework of state procurement, and also cannot be sold in the commercial segment, due to the lack of an approved price.
“Thus, the cessation of sales of just one type of medicine can lead to losses of up to 460 million tenge,” notes the managing director and director of the medical services department of NPP Nazgul Kabdrakhmanova.
Due to the urgency of the problem and its scale, the NCE proposed several key measures to mitigate the consequences of the transition to the EAEU RU. This is the automatic preservation of maximum prices for drugs transferred to the EAEU RU in order to ensure their availability on the market and avoid losses for manufacturers. It is also necessary to review approaches to the formation of the Kazakhstan National Drug Formulary (KNF). It is necessary to take into account the data of the Unified Register of Registered Medicines of the EAEU when forming the National Drug Formulary of Kazakhstan so that drugs of domestic manufacturers with the EAEU RU can be included in the drug procurement lists.
By the way, as representatives of the Committee for Medical and Pharmaceutical Control of the Ministry of Health stated at the meeting, the problems raised by the NPP are extremely urgent and will be taken into account in order to maintain access to medicines for the population of Kazakhstan.
In order to ensure timely and uninterrupted provision of medicines to the population, it is important to quickly respond to today's problems in the pharmaceutical industry. The NCE RK calls on the state body to take measures to eliminate barriers in regulatory acts in order to avoid economic losses and ensure the availability of vital drugs. It is important that all stakeholders, including representatives of the pharmaceutical industry, the Ministry of Health and other regulatory bodies, work together to promptly resolve the problems that have arisen.
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
