This digest contains the most critical updates of the first half of 2021 related to regulatory, safety, and quality affairs for medicines in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Ukraine, Uzbekistan, and the Eurasian Economic Union (EAEU).
The most important in brief:
Azerbaijan:
We kindly remind you that significant amendments to the registration procedure, fast-track assessment, and national pharmacovigilance requirements came into force on July 1, 2020.
EAEU – Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia:
On July 1, EAEU member states completed the transition period during which registration was possible under national procedures and the unified EAEU rules. Submission of Applications for new registration is now only possible under the unified EAEU rules.
Registration certificates obtained under the national registration procedures can be maintained through renewals and variations until December 31, 2025. MAH’s can transfer the registration certificate from the national to EAEU type with the “harmonization of the dossier with EAEU rules” route.
Legislation and business practices of the Union member states are under harmonization with the EAEU.
Georgia:
The duration of registration procedures has been increased due to lockdown measures.
Tajikistan:
On January 29, amendments came into force approving simplified and accelerated registration of medicinal products and medical goods used in military operations, emergencies, outbreaks of epidemics, and other situations.
Ukraine:
Emergency use authorization procedure for vaccines and other medicinal immunobiological products to prevent COVID-19 was approved on February 8, 2021.
Uzbekistan:
Updated Resolution No. 213 “On Approval of the Regulation on the Procedure for State Registration of Medicinal Products, Medical Devices, and Medical Equipment and Issuance of Marketing Authorization” has been publicly discussed and is expected to be approved.
More information on these and other amendments can be found below.
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Azerbaijan: |
Please note that the Rules on the Pharmacovigilance of Medicinal Products and the national Good Pharmacovigilance Practice (GVP) guidelines came into force in Azerbaijan on July 1, 2020.
Marketing authorizations holders must establish and maintain a pharmacovigilance system in Azerbaijan that should include the designation of the local contact person responsible for pharmacovigilance (LQPPV) who meets the qualification requirements and must be employed under the Labour Code of the Republic of Azerbaijan.
Information (name, patronymic, surname, education, and work experience) about the LQQPV and its deputy shall be submitted to the competent authority.
The LQQPV shall establish and maintain a system to collect, assess and submit data on adverse reactions and lack of effectiveness in Azerbaijan, including receiving data, monitoring the specialized literature, receiving, evaluating, and, if necessary, submitting reports on foreign adverse reactions to the medicinal product, submitting a Risk Management Plan (RMP), a Periodic Safety Update Report (PSUR), etc.
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Armenia: |
On July 1, EAEU member states completed the transition period during which registration was possible under national procedures and the unified EAEU rules. Submission of Applications for new registration is now only possible under the unified EAEU rules.
Registration certificates obtained under the national registration procedures can be maintained through renewals and variations until December 31, 2025.
An Application for renewal under the national procedure shall be submitted not earlier than 210 calendar days and not later than the last day before the expiry date of the marketing authorization.
Registration certificates obtained in Armenia and/or in another EAEU member state under the “national” procedure can be transferred to EAEU requirements with the “harmonization of the dossier with EAEU rules” route.
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Belarus: |
On July 1, EAEU member states completed the transition period during which registration was possible under national procedures and the unified EAEU rules. Submission of Applications for new registration is now only possible under the unified EAEU rules.
Registration certificates obtained under the national registration procedures can be maintained through renewals and variations until December 31, 2025.
Marketing Authorizations Holders must submit Periodic Safety Update Reports (PSURs) to the competent authority according to the national requirements of the Republic of Belarus and the EAEU GVP rules.
The frequency and timelines of PSUR submissions are under discussion and are planned to be adopted soon. It is expected that PSUR assessment will be a fee-based procedure, and the expertise is scheduled to start as of November 01, 2021.
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Georgia: |
The duration of registration procedures has been extended due to the epidemiological situation and lockdown measures.
Timelines for registrations in the national regime, recognition regime, renewal of medicinal products, dental materials, and diagnostic products have been extended by 30 days.
The review period of correspondence received by the Regulation Agency for Medical and Pharmaceutical Activities of Georgia is two months.
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Kazakhstan: |
On July 1, EAEU member states completed the transition period during which registration was possible under national procedures and the unified EAEU rules. Submission of Applications for new registration is now only possible under the unified EAEU rules.
Registration certificates obtained under the national registration procedures can be maintained through renewals and variations until December 31, 2025. MAH’s can transfer the registration certificate from the national to EAEU type with the “harmonization of the dossier with EAEU rules” route.
Since the beginning of 2021, several critical legal acts have been approved or amended:
- Code of the Republic of Kazakhstan No. 360-VI of July 7, 2020 “On the Health of the People and the Health Care System.”
- Order of the Minister of Health of the Republic of Kazakhstan No. KR DSM-10 of January 27, 2021 “On Approval of the Rules for Expertise of Medicinal Products and Medical Devices.”
- Order of the Minister of Health of the Republic of Kazakhstan No. KR DSM-11 of January 27, 2021 “On Approval of the Rules for Labelling Medicinal Products and Medical Devices.”
- Order of the Acting Minister of Health of the Republic of Kazakhstan No. KR DSM-15 of February 4, 2021 “On Approval of Good Pharmacy Practices.”
- Order of the Minister of Health of the Republic of Kazakhstan No. KR DSM-16 of February 9, 2021 “On Approval of Rules for State Registration, Renewal of Medicinal Product or Medical Device, Introduction of Amendments to the Registration Dossier of a Medicinal Product or Medical Device.”
- Order of the Minister of Health of the Republic of Kazakhstan No. KR DSM-9 of January 27, 2021 “On Approval of Rules for Pharmaceutical Inspections on Good Pharmaceutical Practices.”
- Order of the Minister of Health of the Republic of Kazakhstan No. KR DSM-320/2020 of December 23, 2020 “On Approval of Rules for Pharmacovigilance and Monitoring of Safety, Quality, and Effectiveness of Medical Device.”.
- Order of the Minister of Health of the Republic of Kazakhstan No. KR DSM-282/2020 of December 20, 2020 “On Approval of the Rules for Quality Assessment of Medicinal Products and Medical Devices Registered in the Republic of Kazakhstan.”
The most significant amendments:
1. The National Centre for Expertise of Medicinal Products and Medical Devices website has published a list of medicinal products that have received indefinite marketing authorizations. An assessment of the benefit-risk ratio shall be performed annually.
According to clauses 48-60 of Order of the MoH No. KR DSM-320/2020 of 23/12/2020 “On Approval of Rules for Pharmacovigilance and Monitoring of Safety, Quality, and Effectiveness of Medical Devices,” the assessment procedure is fee-based and performed based on the Agreement concluded between the marketing authorization holder (MAH) and the National Centre for Expertise.
The reporting period for the annual assessment of the benefit-risk ratio is the date of issuance of the marketing authorization in the Republic of Kazakhstan.
2. Order of the MoH No. KR DSM-282/2020 of 20/12/2020 implemented amendments in the system of state quality control of each batch (lot) of medicinal products imported or manufactured in the Republic of Kazakhstan. Based on an agreement with an expert organization, an applicant shall submit a set of documents to obtain an electronic certificate of compliance. The quality assessment period was reduced from 10 calendar to 5 business days.
The expert organization shall annually develop and agree with the MAH on product sampling and quality control schedule. Sampling shall be carried out at the wholesaler’s warehouse, manufacturer’s finished product warehouse, customs terminal premises, or temporary storage warehouse. Laboratory quality control of samples shall be carried out in accredited testing laboratories, according to the regulatory document (RD) approved during registration.
The supply of standards, reagents, and other materials necessary for quality control and payment for the work shall be the responsibility of the MAH.
3. Order of the MoH of the Republic of Kazakhstan No. KR DSM-56 of June 30, 2021, implemented changes to the rules for pharmaceutical inspections. The GMP certificate for national licensed manufacturers is issued without inspection, based on submitting the Application and guarantee letter to provide the inspection results within six months.
4. The State Register of Medicinal Products and Medical Devices of the Republic of Kazakhstan is moved to register.ndda.kz.
5. The pilot project on digital labeling of medicinal products using Data Matrix was completed on July 31. The draft order “On Approval of the Rules of Medicinal Products Labelling and Traceability” was discussed and finalized.
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Kyrgyzstan: |
On July 1, EAEU member states completed the transition period during which registration was possible under national procedures and the unified EAEU rules. Submission of Applications for new registration is now only possible under the unified EAEU rules.
Registration certificates obtained under the national registration procedures can be maintained through renewals and variations until December 31, 2025. MAH’s can transfer the registration certificate from the national to EAEU type with the “harmonization of the dossier with EAEU rules” route.
The Procedure for State Registration of Medicinal Products for Human Use, approved by Resolution No. 405 of the Government of the Kyrgyz Republic of 28.08.2018, has been amended. The most significant changes:
- A renewal Application shall be submitted no earlier than 180 calendar days before the expiry date of the marketing authorization but no later than the day of its expiry date.
- Applications for amendments may be submitted and examined simultaneously as the Application for Renewal, but each amendment shall be paid for separately.
- The renewal procedure is based on the expert evaluation of the updated data on the benefit-risk ratio of the medicinal product and shall be performed within 90 calendar days.
- The renewal period for medicinal products registered in the USA, Japan, Switzerland, Great Britain, European Medicines Agency (EMA) under a centralized procedure or pre-qualified by WHO is reduced to 25 calendar days.
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Tajikistan: |
Amendments to the Law of the Republic of Tajikistan “On Medicinal Products and Pharmaceutical Activities” entered into force on January 29, 2021, approving simplified registration of medicinal products and medical devices used in military operations, emergencies, outbreaks of epidemics, and other situations.
These changes simplified the registration dossier requirements and shortened timelines for assessment.
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Ukraine: |
The Cabinet of Ministers of Ukraine, on February 8, 2021, adopted Resolution No.95 “Certain Issues of State Registration of Vaccines or Other Medical Immunobiological Products for Specific Prevention of Acute Respiratory Disease COVID-19 Caused by Coronavirus SARS-CoV-2, Under Obligation for Emergency Human Use”.
The Resolution approved procedures for accelerated and simplified registration of vaccines and immunobiological products based on registration or emergency use authorization in the EU, the USA, Great Britain, Switzerland, Japan, Australia, Canada, the PRC or India. The competent authority shall evaluate the benefit/risk ratio and review registration materials within 5 business days, excluding the terms of submission and initial assessment of the Application and issuance of the marketing authorization.
The emergency use authorization issued for one year can be extended if there is no negative benefit/risk ratio or detected adverse reactions. The total period of validity of the marketing authorization may not exceed the validity period of emergency use authorization in the reference country.
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Uzbekistan: |
A list of medicines for the pilot project for digital labeling has been extended by the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 322 of May 20, 2021, “On Measures to Implement Pilot Projects to Extend the List of Products Subject to Mandatory Digital Labelling.”
The pilot project on digital labeling of medicinal products was launched on June 1, 2021. The gradual introduction of mandatory digital labeling for medicinal products is preliminary set for February 1, 2022.
Draft amendments to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 213 of March 23, 2018 “On Approval of the Regulation on the Procedure for State Registration of Medicinal Products, Medical Devices, and Medical Equipment and Issuance of Marketing Authorization” has been publicly discussed and is expected to be approved.
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The Eurasian Economic Union: |
On July 1, EAEU member states completed the transition period during which registration was possible under national procedures and the unified EAEU rules. Submission of Applications for new registration is now only possible under the unified EAEU rules.
Registration certificates obtained under the national registration procedures can be maintained through renewals and variations until December 31, 2025. MAH’s can transfer the registration certificate from the national to EAEU type with the “harmonization of the dossier with EAEU rules” route.
On February 8, 2021, the Council of the Eurasian Economic Commission approved Resolution No.7 “On Amendments to the Rules for Pharmaceutical Inspection,” which enshrined the possibility of remote GMP inspections by telecommunication, i.e., without visiting the manufacturing site.
On March 1, the EAEU Pharmacopoeia came into force. Marketing authorization holders are required to bring their regulatory documents (RD) into compliance with the requirements of the EAEU Pharmacopoeia by 01/01/2026.
On April 23, the Eurasian Economic Commission website published a decision on extending the transition period for GMP in the EAEU. National GMP Applications can be submitted until December 31, 2021, and starting from 2022 GMP Applications can be submitted only under the EAEU Rules. It is allowed to submit the national GMP certificates for the establishment of registration under the EAEU Rules.
The requirements for bringing the dossier into compliance with the EAEU rules for medicinal products to be circulated in the territory of only one member state have been simplified by the decision of the EEC Council. Marketing authorization holders may submit a dossier containing only Modules 1-3 and submit Modules 4 and 5, if any, for the harmonization procedure.
At the end of August, there were 481 entries in the Unified Register of Registered Medicinal Products of the Eurasian Economic Union.
On August 18, the Eurasian Economic Commission’s portal posted for public discussion draft amendments to the rules for registration and expertise of medicinal products. The following amendments are proposed for introduction:
- expanding the possibility of importing unregistered medicinal products for a specific patient (analogous to the Named Patient Programme);
- developing the groups of unregistered medicinal products to which access is granted in special conditions;
- the possibility of concurrent review of Applications by several states of recognition in the mutual recognition procedure and amendments before the start of its review in the recognition states;
- the possibility of submitting Module 1 electronically;
- the possibility of simultaneous mutual recognition procedures in several states;
- adding special procedures for registration of medicinal products in exceptional cases, conditional registration of products, and accelerated expert examination.
Discussions on the draft will continue until September 17.
Cratia provides professional services of registration of medicines, establishment and maintenance of pharmacovigilance and quality management in 12 countries of the CIS region.
If you have any questions, we will be happy to answer them by email info@cratia.com, by phone +38 044 332-42-94, or at a meeting in our office.