On October 31, 2025, in Almaty, the Association for the Support and Development of Pharmaceutical Activities of the Republic of Kazakhstan, with the support of the branch of the Republican State Enterprise on the Right of Economic Management "National Center for Expertise of Medicines and Medical Devices", held a round table on the topic "Pharmaceutical space of Kazakhstan and the EAEU: from registration to provision."
The event was attended by: T.M. Muratov, Vice-Minister of Health of the Republic of Kazakhstan; D.M. Dikhanbaev, Director General of the Republican State Enterprise on the Right of Economic Management "National Center for Expertise and Medical Research"; G.U. Raimkulova, Deputy Chairperson of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan; D.A. Dauletbaev, Head of the Department of Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan for Almaty; A.T. Bayanberdiyeva, Deputy Director of the Department of Drug Policy of the Ministry of Health of the Republic of Kazakhstan, and others.
The meeting was held in a question-and-answer format, allowing participants—representatives of government agencies, expert organizations, and the pharmaceutical community—to discuss the most pressing issues of drug supply, registration, pricing, and taxation in anticipation of the transition to new EAEU regulations.
As is known, by December 31, 2025, all drug manufacturers and their official representatives planning to continue their activities in the market of the Eurasian Union countries must submit applications to bring their registration dossier into compliance with the requirements of the Eurasian Union, and the first question is on this topic.
Will companies be able to import and sell medicines produced before submitting an application to bring their registration dossier into compliance with EAEU requirements using their old national registration certificates? Will a single official explanatory letter from the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan be sufficient for all market participants?
Yes, they can. Legislation explicitly permits this. A medicinal product manufactured or imported during the validity period of its national registration certificate may be sold and used until its expiration date. This regulation is stipulated both in the Code of the Republic of Kazakhstan "On Public Health" and in documents of the Eurasian Economic Commission (EEC). There is no requirement to receive individual letters from the Committee for each batch or company. For this rule to be effective, a company must submit an application to bring its registration dossier into compliance with EEC Decision No. 78 by December 31, 2025.
Submitting an application automatically extends the validity of your national RU for the entire duration of the compliance procedure.
For the recognizing country: extension for 2 years.
For the country of registration: extension for 3 years.
During this period, your national RU is legally valid and can be used for work.
How will deregulation of prescription drug prices take place?
According to the current plan, deregulation of prescription drug prices was planned for 2026. However, due to changes in the tax system (the introduction of VAT on medications), a decision was made to postpone full deregulation of the retail segment until 2027.
At the same time, prices for prescription drugs priced at less than one minimum monthly calculation index (approximately 3,990 tenge) will be liberalized as early as 2026. These drugs will be exempt from state regulation, and manufacturers will no longer have to submit price-fixing requests.
According to the analysis, approximately 48% of medications cost less than one minimum monthly calculation index (MCI). Therefore, almost half of the medications will be deregulated by 2026. The ministry believes this gradual deregulation will help preserve low-priced medications on the market and prevent their erosion.
- Will VAT be charged on top of the approved maximum price or included in its structure?
VAT will be charged on top of the approved maximum price, rather than included in it. Amendments have been made to draft Order No. 247: maximum prices for medicines are now set exclusive of VAT.
From January 1, 2026, the Tax Code introduces a 5% VAT rate on medicines and medical devices, which will increase to 10% in 2027.
The Ministry of Health has developed a draft resolution on the exemption from VAT of medicines used under the State Fund for Medical Care and the Compulsory Health Insurance System, as well as in the treatment of orphan and socially significant diseases.
Pharmaceutical substances and semi-finished products will also be exempt from VAT if they are used to produce medicines under the State Fund for Free Medical Care and the Compulsory Medical Insurance Programs, and will be taxed at a rate of 5% when sold at retail.
How will VAT be applied to medical products and how will this affect the final cost to patients?
Medical products will be subject to a 5% VAT. The draft resolution establishing this mechanism is currently being reviewed by government agencies.
Administrative issues remain, as some products may be subject to different VAT rates (5% and 16%), complicating accounting. The Ministry of Health, together with the Ministry of Finance and the State Revenue Committee, is developing a tax administration mechanism.
A unified position on the application of VAT to medical devices will be developed by December 1 of this year, and will be adjusted in the first half of 2026 based on the results of the practical application of the new tax regulations.
How will continuity of treatment for patients with orphan diseases be ensured from January 1, 2026, if the Kazakhstan Health Foundation stops purchasing drugs?
- The Ministry of Health is carrying out comprehensive work to systematize and provide therapy for orphan diseases.
First, a Republican Orphan Center is being established to develop clinical criteria for prescribing orphan drugs and clarify indications for therapy, taking into account age and genetic confirmation of the diagnosis. This will help avoid unnecessary prescriptions and ensure treatment is provided to those truly indicated.
Secondly, the Ministry of Health is developing rules for defining orphan diseases and creating a unified national list of such diseases. Currently, there is no unified definition of orphan diseases globally—different countries use different criteria (for example, in Europe it's 50 cases per 100,000 people, while in the United States it's 10 per 100,000). Kazakhstan will adopt its own criteria, which will be used to create an official list.
As for funding, a small number of orphan drugs (1–2 positions) will remain in the funding of the republican budget.
The majority of orphan diseases will be covered by local budgets (akimats, maslikhats, and health departments). Preliminary agreements have already been reached with the regions.
At the same time, a reduction in the volume of drug purchases is expected compared to previous years, which is caused by the need for targeted personalization of treatment.
Drug registration remains mandatory: no public organization, including the Kazakhstan Health Foundation, will be able to purchase unregistered drugs. The Ministry has introduced a requirement for a maximum price and a registration certificate to ensure transparency and cost control.
Also in 2026, a state genetic laboratory will begin operations, which will allow for the confirmation of diagnoses and the establishment of indications for therapy at the national level.
Thus, the system for providing orphan drugs will remain in place, but will become more targeted and manageable, with responsibility divided between the national and local budgets.
When will the list of orphan diseases and drugs, which has not been revised since 2021, be updated?
- Work on updating the list is indeed underway, but has been temporarily suspended.
The Ministry of Health is currently preparing amendments to Order No. ҚР ДСМ-135/2020 dated October 16, 2020, which regulates the rules for compiling the list of orphan diseases; strengthens the requirements for determining the diagnosis and orphan status of diseases; and is finalizing the draft order taking into account the legal comments of the Ministry of Justice.
After the new rules are approved, the list of orphan diseases will be updated, and then the list of drugs used.
Work has been suspended until funding is resolved. Once budgetary arrangements are determined, renovation work will resume.
The new list is tentatively planned to be approved by the end of 2025, but it will be more compact than previously expected.
Will the Ministry of Health have time to sign the updated Order No. ҚР ДСМ-16 of the Ministry of Health dated February 9, 2021, by the end of 2025, which will allow for the submission of applications to bring the registration dossiers of strategically important medicinal products into compliance with EAEU regulations?
Yes, the approval process for the order is in its final stages. Order No. 16, which regulates the rules for state registration, re-registration, and amendments to registration dossiers of medicines and medical devices, has already been approved by the Ministry of Justice.
The document was temporarily returned due to technical amendments related to departmental name changes following the reorganization of the Ministry of Digitalization. These issues have now been addressed, and the order has been resubmitted to the Ministry of Justice for registration.
In parallel, consideration is being given to amending Decision No. 78, where paragraph 3 of the general provisions limits the ability to align strategically important drugs with EAEU procedures. Kazakhstan has submitted an official request to the Eurasian Economic Commission for clarification. Once a response is received, the information will be published on official resources.
Thus, Order No. 16 is planned to be approved by the end of 2025, which will allow companies to begin submitting applications in accordance with EAEU requirements within the established deadlines.
If registration is carried out using a composite service (national procedure), the drug, after receiving the registration certificate, must also be brought into compliance with the EAEU rules in accordance with Order No. 16.
There are approximately 6,900 medicinal products registered in the state register, and approximately 4,700–5,000 in circulation. Currently, 67% of them have been brought into compliance with the requirements of the EAEU.
Recommendation: Don't delay submitting applications until the last day. Submitting an application before December 31, 2025, will automatically extend the registration and keep your product on the market.
Government officials explained in great detail the meaning and benefits of the composite service.
The Committee representative noted that since the signing of the 2016 Agreement, Kazakhstan has been actively moving toward the EAEU's common medicines market. However, due to constant postponements and the lack of stable forecasts, the country is forced to develop its own national registration procedure—specifically, the composite service.
The composite service was created to reduce timeframes and consolidate several procedures that previously required separate organizations and took up to five years. Now, everything is handled through a single window—within 100 business days.
The composite service includes three interrelated processes:
Registration of a medicinal product
Conducted by the National Center for Expertise of Medicines and Medical Devices (NCEMD).
Applies only to drugs not registered in the EAEU countries.
A fourth service is planned for implementation: automatic updating of clinical protocols related to a registered drug.
Previously, the price was approved in stages: wholesale once every six months, retail once a year.
The process is now integrated with registration: when submitting documents for registration, the system automatically generates a price based on reference data from several databases (including foreign ones).
The calculation is completed within a few minutes, after which the data is automatically entered into the register of maximum prices (according to orders No. 77 and No. 96).
Once registration is approved, the information is automatically transferred to the National Center for Health Development (NCHD) to consider the inclusion of the drug in the formulary.
The service delivery period is up to 100 business days for all three (in the future – four) procedures.
The algorithm is designed in such a way that the manufacturer submits a package of documents once, and interaction between organizations occurs without his participation.
This is a national service, meaning it applies only to Kazakhstan and is not an EAEU procedure. After registration under this composite service, the drug must be brought into compliance with EAEU requirements under Order No. 16.
The pricing methodology is regulated by Order No. 67, which specifies the criteria and mechanisms by which prices are determined. It is simpler than the previous Order No. 247.
If several companies submit a single INN, the system uses the current prices available in the registers and automatically recalculates the reference values.
To date, over 6,500 drugs have been added to the KNF—almost as many as are actually in circulation. This confirms that the state is the primary purchaser of pharmaceuticals.
Only drugs with a high level of evidence (A-B) are included in the CNF. Drugs with a level of evidence of C or lower, even those considered safe, are generally not included, even though they are used in clinical practice.
The composite service will systematize this process and, in the future, automate the updating of clinical protocols.
Representatives of the Ministry of Health noted that a number of issues under discussion—in particular, VAT administration for imported medicines, the procedure for filing declarations, and interaction with the State Revenue Committee and customs authorities—are beyond the purview of the Ministry of Health and require the participation of other agencies.
In this regard, a decision was made to initiate a separate round table with the participation of representatives of the State Revenue Committee (SRC), customs authorities, and, if possible, applicants (representatives of pharmaceutical companies).
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
The event was attended by: T.M. Muratov, Vice-Minister of Health of the Republic of Kazakhstan; D.M. Dikhanbaev, Director General of the Republican State Enterprise on the Right of Economic Management "National Center for Expertise and Medical Research"; G.U. Raimkulova, Deputy Chairperson of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan; D.A. Dauletbaev, Head of the Department of Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan for Almaty; A.T. Bayanberdiyeva, Deputy Director of the Department of Drug Policy of the Ministry of Health of the Republic of Kazakhstan, and others.
The meeting was held in a question-and-answer format, allowing participants—representatives of government agencies, expert organizations, and the pharmaceutical community—to discuss the most pressing issues of drug supply, registration, pricing, and taxation in anticipation of the transition to new EAEU regulations.
As is known, by December 31, 2025, all drug manufacturers and their official representatives planning to continue their activities in the market of the Eurasian Union countries must submit applications to bring their registration dossier into compliance with the requirements of the Eurasian Union, and the first question is on this topic.
Will companies be able to import and sell medicines produced before submitting an application to bring their registration dossier into compliance with EAEU requirements using their old national registration certificates? Will a single official explanatory letter from the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan be sufficient for all market participants?
Yes, they can. Legislation explicitly permits this. A medicinal product manufactured or imported during the validity period of its national registration certificate may be sold and used until its expiration date. This regulation is stipulated both in the Code of the Republic of Kazakhstan "On Public Health" and in documents of the Eurasian Economic Commission (EEC). There is no requirement to receive individual letters from the Committee for each batch or company. For this rule to be effective, a company must submit an application to bring its registration dossier into compliance with EEC Decision No. 78 by December 31, 2025.
Submitting an application automatically extends the validity of your national RU for the entire duration of the compliance procedure.
For the recognizing country: extension for 2 years.
For the country of registration: extension for 3 years.
During this period, your national RU is legally valid and can be used for work.
How will deregulation of prescription drug prices take place?
According to the current plan, deregulation of prescription drug prices was planned for 2026. However, due to changes in the tax system (the introduction of VAT on medications), a decision was made to postpone full deregulation of the retail segment until 2027.
At the same time, prices for prescription drugs priced at less than one minimum monthly calculation index (approximately 3,990 tenge) will be liberalized as early as 2026. These drugs will be exempt from state regulation, and manufacturers will no longer have to submit price-fixing requests.
According to the analysis, approximately 48% of medications cost less than one minimum monthly calculation index (MCI). Therefore, almost half of the medications will be deregulated by 2026. The ministry believes this gradual deregulation will help preserve low-priced medications on the market and prevent their erosion.
- Will VAT be charged on top of the approved maximum price or included in its structure?
VAT will be charged on top of the approved maximum price, rather than included in it. Amendments have been made to draft Order No. 247: maximum prices for medicines are now set exclusive of VAT.
From January 1, 2026, the Tax Code introduces a 5% VAT rate on medicines and medical devices, which will increase to 10% in 2027.
The Ministry of Health has developed a draft resolution on the exemption from VAT of medicines used under the State Fund for Medical Care and the Compulsory Health Insurance System, as well as in the treatment of orphan and socially significant diseases.
Pharmaceutical substances and semi-finished products will also be exempt from VAT if they are used to produce medicines under the State Fund for Free Medical Care and the Compulsory Medical Insurance Programs, and will be taxed at a rate of 5% when sold at retail.
How will VAT be applied to medical products and how will this affect the final cost to patients?
Medical products will be subject to a 5% VAT. The draft resolution establishing this mechanism is currently being reviewed by government agencies.
Administrative issues remain, as some products may be subject to different VAT rates (5% and 16%), complicating accounting. The Ministry of Health, together with the Ministry of Finance and the State Revenue Committee, is developing a tax administration mechanism.
A unified position on the application of VAT to medical devices will be developed by December 1 of this year, and will be adjusted in the first half of 2026 based on the results of the practical application of the new tax regulations.
How will continuity of treatment for patients with orphan diseases be ensured from January 1, 2026, if the Kazakhstan Health Foundation stops purchasing drugs?
- The Ministry of Health is carrying out comprehensive work to systematize and provide therapy for orphan diseases.
First, a Republican Orphan Center is being established to develop clinical criteria for prescribing orphan drugs and clarify indications for therapy, taking into account age and genetic confirmation of the diagnosis. This will help avoid unnecessary prescriptions and ensure treatment is provided to those truly indicated.
Secondly, the Ministry of Health is developing rules for defining orphan diseases and creating a unified national list of such diseases. Currently, there is no unified definition of orphan diseases globally—different countries use different criteria (for example, in Europe it's 50 cases per 100,000 people, while in the United States it's 10 per 100,000). Kazakhstan will adopt its own criteria, which will be used to create an official list.
As for funding, a small number of orphan drugs (1–2 positions) will remain in the funding of the republican budget.
The majority of orphan diseases will be covered by local budgets (akimats, maslikhats, and health departments). Preliminary agreements have already been reached with the regions.
At the same time, a reduction in the volume of drug purchases is expected compared to previous years, which is caused by the need for targeted personalization of treatment.
Drug registration remains mandatory: no public organization, including the Kazakhstan Health Foundation, will be able to purchase unregistered drugs. The Ministry has introduced a requirement for a maximum price and a registration certificate to ensure transparency and cost control.
Also in 2026, a state genetic laboratory will begin operations, which will allow for the confirmation of diagnoses and the establishment of indications for therapy at the national level.
Thus, the system for providing orphan drugs will remain in place, but will become more targeted and manageable, with responsibility divided between the national and local budgets.
When will the list of orphan diseases and drugs, which has not been revised since 2021, be updated?
- Work on updating the list is indeed underway, but has been temporarily suspended.
The Ministry of Health is currently preparing amendments to Order No. ҚР ДСМ-135/2020 dated October 16, 2020, which regulates the rules for compiling the list of orphan diseases; strengthens the requirements for determining the diagnosis and orphan status of diseases; and is finalizing the draft order taking into account the legal comments of the Ministry of Justice.
After the new rules are approved, the list of orphan diseases will be updated, and then the list of drugs used.
Work has been suspended until funding is resolved. Once budgetary arrangements are determined, renovation work will resume.
The new list is tentatively planned to be approved by the end of 2025, but it will be more compact than previously expected.
Will the Ministry of Health have time to sign the updated Order No. ҚР ДСМ-16 of the Ministry of Health dated February 9, 2021, by the end of 2025, which will allow for the submission of applications to bring the registration dossiers of strategically important medicinal products into compliance with EAEU regulations?
Yes, the approval process for the order is in its final stages. Order No. 16, which regulates the rules for state registration, re-registration, and amendments to registration dossiers of medicines and medical devices, has already been approved by the Ministry of Justice.
The document was temporarily returned due to technical amendments related to departmental name changes following the reorganization of the Ministry of Digitalization. These issues have now been addressed, and the order has been resubmitted to the Ministry of Justice for registration.
In parallel, consideration is being given to amending Decision No. 78, where paragraph 3 of the general provisions limits the ability to align strategically important drugs with EAEU procedures. Kazakhstan has submitted an official request to the Eurasian Economic Commission for clarification. Once a response is received, the information will be published on official resources.
Thus, Order No. 16 is planned to be approved by the end of 2025, which will allow companies to begin submitting applications in accordance with EAEU requirements within the established deadlines.
If registration is carried out using a composite service (national procedure), the drug, after receiving the registration certificate, must also be brought into compliance with the EAEU rules in accordance with Order No. 16.
There are approximately 6,900 medicinal products registered in the state register, and approximately 4,700–5,000 in circulation. Currently, 67% of them have been brought into compliance with the requirements of the EAEU.
Recommendation: Don't delay submitting applications until the last day. Submitting an application before December 31, 2025, will automatically extend the registration and keep your product on the market.
Government officials explained in great detail the meaning and benefits of the composite service.
The Committee representative noted that since the signing of the 2016 Agreement, Kazakhstan has been actively moving toward the EAEU's common medicines market. However, due to constant postponements and the lack of stable forecasts, the country is forced to develop its own national registration procedure—specifically, the composite service.
The composite service was created to reduce timeframes and consolidate several procedures that previously required separate organizations and took up to five years. Now, everything is handled through a single window—within 100 business days.
The composite service includes three interrelated processes:
Registration of a medicinal product
Conducted by the National Center for Expertise of Medicines and Medical Devices (NCEMD).
Applies only to drugs not registered in the EAEU countries.
A fourth service is planned for implementation: automatic updating of clinical protocols related to a registered drug.
Previously, the price was approved in stages: wholesale once every six months, retail once a year.
The process is now integrated with registration: when submitting documents for registration, the system automatically generates a price based on reference data from several databases (including foreign ones).
The calculation is completed within a few minutes, after which the data is automatically entered into the register of maximum prices (according to orders No. 77 and No. 96).
Once registration is approved, the information is automatically transferred to the National Center for Health Development (NCHD) to consider the inclusion of the drug in the formulary.
The service delivery period is up to 100 business days for all three (in the future – four) procedures.
The algorithm is designed in such a way that the manufacturer submits a package of documents once, and interaction between organizations occurs without his participation.
This is a national service, meaning it applies only to Kazakhstan and is not an EAEU procedure. After registration under this composite service, the drug must be brought into compliance with EAEU requirements under Order No. 16.
The pricing methodology is regulated by Order No. 67, which specifies the criteria and mechanisms by which prices are determined. It is simpler than the previous Order No. 247.
If several companies submit a single INN, the system uses the current prices available in the registers and automatically recalculates the reference values.
To date, over 6,500 drugs have been added to the KNF—almost as many as are actually in circulation. This confirms that the state is the primary purchaser of pharmaceuticals.
Only drugs with a high level of evidence (A-B) are included in the CNF. Drugs with a level of evidence of C or lower, even those considered safe, are generally not included, even though they are used in clinical practice.
The composite service will systematize this process and, in the future, automate the updating of clinical protocols.
Representatives of the Ministry of Health noted that a number of issues under discussion—in particular, VAT administration for imported medicines, the procedure for filing declarations, and interaction with the State Revenue Committee and customs authorities—are beyond the purview of the Ministry of Health and require the participation of other agencies.
In this regard, a decision was made to initiate a separate round table with the participation of representatives of the State Revenue Committee (SRC), customs authorities, and, if possible, applicants (representatives of pharmaceutical companies).
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
