Regulatory newsletter for CIS and EAEU

Dear сolleagues,

In this digest, you will find the most important news on the registration, pharmacovigilance and quality control of medicines in Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Ukraine, Uzbekistan, and the Eurasian Economic Union (EAEU) which came into effect at the end of 2023 and the first half of 2024.

In brief:

Armenia:
On April 25, 2024 the competent regulatory authority for the assessment of medicines and medical devices in Armenia was changed. On April 30, 2024 bank details for payment of state fees for the registration, renewal and variations have been changed.
From January 1, 2024 a transition period to EAEU rules for registration of medicines has ended. Submission of new registration is possible only under EAEU rules, while medicines registered under the national regime should transfer to EAEU by December 31, 2025.

Azerbaijan:
On June 5, 2024 the regulatory authority published an announcement on its website on the suspension of medical device imports in anticipation of introducing a registration procedure.
On March 18, 2024 changes to pharmacovigilance rules were approved. The regulatory authority has published the PSUR submission schedule on its website.
From January 1, 2024 the first phase of serialization for psychotropic and potent medicines has started.
On July 14, 2023 significant amendments to the Law “On Pharmaceuticals” were approved, which implemented the fast-track registration of medicines approved in highly regulated markets, registration of medical devices and changes to regulation of dietary supplements, and became effective on August 15, 2023.

Georgia:
On March 27, 2024 the mandatory submission of GMP certificates for national regulatory procedures was postponed to October 1, 2024.

Kazakhstan:
From July 1, 2024 the introduction of mandatory serialization of medicines is planned.
From January 1, 2024 a transition period to EAEU rules for registration of medicines has ended. Submission of new registration is possible only under EAEU rules, while medicines registered under the national regime should transfer to EAEU by December 31, 2025.
On June 7, 2023 amendments to the rules for quality assessment of pharmaceuticals and medical devices registered in Kazakhstan were approved.

Kyrgyzstan:
From March 1, 2024 the transition period has ended and mandatory serialization of medicines has become effective.
From January 1, 2024 a transition period to EAEU rules for registration of medicines has ended. Submission of new registration is possible only under EAEU rules, while medicines registered under the national regime should transfer to EAEU till December 31, 2025.

Moldova:
In December 2023 the Agency for Medicines and Medical Devices (AMDM), the regulatory authority of Moldova, launched the Med Safety application for reporting adverse drug reactions.

Mongolia:
In January 2024 the address for the Department of Drug Control and Regulation, the regulatory authority of Mongolia, changed.
In April 2024 submission of applications for OTC drug advertising permits via the state platform has been introduced.

Ukraine:
In May and June 2024, changes were made to the procedure for confirming GMP certificates, extending the decision period for recognition to the validity period of the GMP certificate.
On May 14, 2024, changes to the procedure for registering medicinal products came into effect, consolidating changes made during the period of martial law and clarifying certain aspects of the registration of medicinal products.
From April 17, 2024, simplifications regarding the recognition of GMP certificates were canceled, and the import of medicinal products without decisions from the State Service of Ukraine on Medicines and Drug Control on the recognition of the GMP certificate is prohibited. The batch of the medicinal product must be produced during the validity period of the GMP certificate, which is either recognized or issued by the State Service of Ukraine on Medicines and Drug Control.
On February 16, 2024, the Law on the Regulation of Circulation of Cannabis-Based Medicinal Products was adopted, which will come into effect on August 16, 2024. Currently, amendments to related regulatory acts are being developed.
In December 2023, changes to the procedure for the assessment of medicinal products came into effect, allowing the submission of dossiers in eCTD format, with a test period until the end of 2024 and a preliminary mandatory submission date of August 18, 2025. These changes also restrict marketing information on the packaging and in the instructions for use.
A new procedure for pharmacovigilance, which will significantly change the current regulation, is under public discussion.

Uzbekistan:
On April 1, 2024 the state registration of active pharmaceutical ingredients (APIs) was cancelled.
On March 1, 2024 the control of ethylene glycol and diethylene glycol in certain drug forms became mandatory.

EAEU:
On May 6, 2024, the procedure for making changes (variations) to registration materials was amended, including clarifying the deadlines for IAin changes, describing the process for making simultaneous changes, and the rules for grouping changes.
On February 20, 2024, changes were made to the rules for conducting bioequivalence studies, allowing the acquisition of reference products in third countries, the use of generics as references, and aligning the requirements for the biowaiver procedure with global practices.
On February 4, 2024, changes were made to the rules for conducting studies on biological medicinal products, including the exclusion of the need for large-scale therapeutic equivalence studies and other changes.
On November 10, 2023, requirements for the serialization of medicinal products (marking with identification means) came into effect. The responsibility for marking medicinal products produced in the EAEU lies with the manufacturer, and the responsibility for marking imported medicines lies with the holder of the registration certificate.
On October 20, 2023, changes were made to simplify the procedure for bringing the registration dossier in line with Union requirements.
On October 3, 2023, guidelines for assessing the significance of medicinal products for public health for the purpose of accelerated examination during their registration were approved. On September 25, 2023, changes to the rules for the registration and examination of medicinal products were approved, including the conduct of periodic benefit-risk assessments for indefinite registration certificates, extending the response time to regulatory authority requests from 90 calendar days to 180 working days, expanding the reasons for issuing indefinite registrations, and allowing significant changes during the procedure for bringing them in line with EAEU requirements.
On September 5, 2023, guidelines for preparing Module 1 of the registration dossier for the mutual recognition procedure and the decentralized procedure were presented.
We remind you that on January 1, 2024, the transition to registration under the Unified Rules took place in the EAEU member countries: applications for the new registration of medicinal products can only be submitted under EAEU legislation. Medicinal products registered under national rules may be marketed until December 31, 2025. To transition from national registration to registration under EAEU rules, it is necessary to undergo the procedure of bringing the dossier in line with the requirements (regulatory procedure similar to eCTD baseline dossier submission).

Below you can find more information on these and other changes (the reading time is app. 12 minutes).

Armenia:

From May 8, 2024, a state fee for the examination of pharmaceuticals and medical devices is charged in accordance with Article 20.3 of the Law “On State Duty.”

On April 25, 2024, the functions, duties, and rights of the Academician Emil Gabrielyan Center for Drug and Medical Technology Expertise are transferred to the new regulatory authority, the State Non-Commercial Organization “Drug and Medical Technology Expertise Center.” All correspondence, including registration applications, re-registration, amendments, letters, requests, and other documents, should be addressed to the SNCO “Drug and Medical Technology Expertise Center” at 49/5 Komitas Ave., Yerevan, 0051, Armenia, or email info@ampra.am.
The payment details for registration, re-registration, and amendments, as well as the forms for registration applications and document submission, were changed on April 30, 2024. The SNCO “Drug and Medical Technology Expertise Center” will not issue invoices, and the state fee payment is made locally under the Law “On State Duty.”
The website https://ampra.am/ is under development and not yet operational at the time of this news release. The email vigilance@pharm.am remains active alongside the implementation of the new address.

On January 1, 2024, the transition to the Unified Registration Rules in the EAEU member states took place: submission of applications for new drug registration is only possible under EAEU legislation. Pharmaceuticals registered under national rules can be marketed until December 31, 2025. To transition from national registration to EAEU rules, the dossier must be brought into compliance with Union’s requirements (regulatory procedure similar to submission of the eCTD baseline dossier).

Azerbaijan:

On June 5, 2024, a notice for importers was published on the website of the Center for Analytical Expertise (the regulatory body for medicines and medical devices in Azerbaijan) of the Ministry of Health of the Republic of Azerbaijan regarding the suspension of processing documents for the import of medical devices. Medical devices in Azerbaijan were not subject to state registration and could be imported and placed on the market without a registration certificate. Amendments to the Law of the Republic of Azerbaijan “On Medicines” introduced the procedure for the state registration of medical devices in 2023. For some time, the registration regulations were under development. In connection with the upcoming start of the registration process, the CAE temporarily suspends the submission and evaluation of documents for the import of medical devices, except for class I devices, as well as the verification of whether a product is classified as a medical device.

On May 6, 2024, amendments to the “Rules for the Pharmacovigilance of Medicines”, approved by Resolution No. 503 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019, came into force. In connection with the entry into force of the amendments, a schedule for the frequency and deadlines for submitting Periodic Safety Update Reports (PSUR) for medicines was published on the website of the Center for Analytical Expertise. Holders of registration certificates can apply to the regulatory body with a request to review the dates by September 1, 2024.

From January 1, 2024, the first stage of serialization of medicines for psychotropic and potent drugs is introduced. An information system for tracking and monitoring medicines (DVTIS) has been developed, which allows electronic tracking of coded medicines according to the GS1 2D Datamatrix format. The system allows importing QR codes according to the regulations of the European Union, USA, India, and other countries. This system is intended for use by local manufacturers and importers, distributors, pharmacies, and medical institutions. According to our information, the introduction of the second stage of serialization is postponed from June 1, 2024, until the adoption of legislative acts on serialization.

On July 14, 2023, significant amendments to the Law of the Republic of Azerbaijan “On Medicines” were approved, which came into force on August 15, 2023. Among the most significant innovations are:

• gradual implementation of medicine serialization;
• introduction of a simplified registration (recognition) procedure and approval of a list of reference countries and recognition organizations;
• establishment of the foundations for the state registration of medical devices (note that as of today, medical devices are not subject to state registration in Azerbaijan);
• the sale and use of medicines introduced into circulation during the period of registration is allowed after the registration period expires;
• in state registration, packaging approval is allowed in Azerbaijani, Turkish, Russian, English, German, Spanish, Italian, French, and Hungarian languages;
• the deadlines for initial examination (15 working days) and specialized examination (90 calendar days) for new registration and re-registration have been clarified;
• requirements for advertising, storage, and sale of dietary supplements (biologically active food supplements) have been tightened, requiring them to be sold separately from medicines and with appropriate labeling.

The recognition procedure involves submitting an Application and a simplified registration dossier, including a notarized translation of the instructions into Azerbaijani and packaging layouts, which can be submitted in the language of the recognition country. The list of recognition countries was approved by Resolution No. 480 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 26, 2023. The list includes 38 countries, including the USA, Japan, EU countries, EFTA and EUCU countries, as well as WHO and EMA. Registration, including examination, is carried out within 9 working days from the date of application submission, excluding the time for responses to comments, contract signing, and payment of expert work and state fees. An important feature of the recognition procedure is the tight deadlines imposed not only on the regulatory body of Azerbaijan but also on the Applicant: responses to comments must be addressed within 10 working days, and the contract with the regulatory body, payment for expert work, and state fee must be completed within 2 working days.

Regarding dietary supplements, the following restrictions and limitations have been introduced:

• mandatory mention in advertising that the product is not a medicinal product with the same font and background as the name of the dietary supplement;
• the trade name of the supplement must differ from the registered medicinal product by at least 4 letters;
• the name of the dietary supplement cannot include the name of substances from its composition;
• the trade name of the dietary supplement must be accompanied by a statement that the product is not a medicine on the labeling, in the instructions for use, and other documentation;
• dietary supplements must be stored and sold separately from medicinal products, with a designation that these products are not medicinal products.

Georgia:

By Resolution No. 99 of the Government of Georgia dated March 27, 2024, the mandatory submission date for GMP certificates for regulatory procedures in the national regime has been postponed to October 1, 2024. We remind you that by Resolution No. 114 of the Government of Georgia dated March 4, 2022, the requirement was established for the mandatory submission of a GMP certificate issued by the regulatory authority of the EU member states, the US Food and Drug Administration (US FDA), the regulatory authority of the member countries of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), or confirmation of prequalification by the World Health Organization (WHO) or the regulatory authority of Georgia regarding compliance with national GMP standards. Please note that if the GMP certificate expires, the registration of the medicinal product will be suspended and will resume after the submission of a valid certificate.
Since December 2023, amendments to the Law “On Medicines and Pharmaceutical Activities” have come into force, allowing the direct procurement of medicines from manufacturers or holders of registration certificates to increase the efficiency of public spending and the number of funded medicines based on treatment courses. Medicines will be purchased under special conditions using the Managed Entry Agreement mechanism, which means acquiring medicines at a special price.

Kazakhstan:

From July 1, 2024, mandatory serialization of medicines is introduced in Kazakhstan. All medicines imported into Kazakhstan must include an identification means—a two-dimensional matrix barcode in the Data Matrix format.
The requirements and method of applying the identification means, the procedure for submitting data to the electronic labeling and traceability system for goods, are approved by the Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021, No. ҚР ДСМ-11 “On Approval of the Rules for Labeling and Traceability of Medicines and Labeling of Medical Devices.” The receipt of labeling codes for imported medicines is carried out by the holders of registration certificates, manufacturers, their authorized representatives and/or branches (subsidiaries), or importers. The 2D code is applied directly during production or by sticker application.
To make changes to existing labeling or to add additional packaging with space for applying a 2D code, the Application for changes (variations) must be submitted. At this stage, the registration of an additional layout with serialization is allowed.
At the time of news layout, the discussion of changes to the list of products subject to labeling has been completed and the document is awaiting signing. If the changes are adopted, medicines produced before July 1, 2024, may be imported into the territory of the Republic of Kazakhstan without mandatory labeling.

The regulatory authority’s website has published the 2024 sample selection plan for quality assessment of medicines and medical devices, as well as a list of products for which laboratory tests of product samples were not conducted in 2023. We remind you that the sampling from the market and quality control is an annual procedure conducted by the regulatory authority of Kazakhstan. The regulatory authority forms and approves the sampling plan, based on which manufacturers, registration holders, or authorized representatives of the manufacturer of medical devices conclude a contract and agree on the sampling schedule for laboratory quality control. Certificates of conformity for products that did not pass market sampling are suspended.

By Order No. 105 of the Minister of Health of the Republic of Kazakhstan dated June 7, 2023, amendments were made to the Rules for Quality Assessment of Medicines and Medical Devices registered in the Republic of Kazakhstan. For the import of medicines, it is necessary to provide a duly legalized copy of the GMP certificate valid at the time of product manufacture or a Declaration from the manufacturer indicating the current GMP status on the US FDA website and the address of the registry of GMP compliance certificates issued by an authorized organization.

Based on WHO warning letters about contamination of liquid medicinal products, the regulatory authority of Kazakhstan recommended controlling the presence of ethylene glycol and diethylene glycol impurities in liquid medicinal products containing propylene glycol, polyethylene glycol, sorbitol, and glycerin. If control of these impurities in excipients is absent, it is necessary to update the specifications by making changes. The permissible limit for ethylene glycol and diethylene glycol impurities is no more than 0.1%.

The regulatory authority of Kazakhstan has opened an electronic portal for submitting applications for all EAEU procedures. The portal is available to legal entities in the Republic of Kazakhstan that have an electronic digital signature and is used for contract conclusion, payment, and uploading an electronic registration dossier in the EAEU eCTD format (XML + PDF).

On January 1, 2024, the transition to the Unified Registration Rules in the EAEU member states took place: submission of applications for new drug registration is only possible under EAEU legislation. Pharmaceuticals registered under national rules can be marketed until December 31, 2025. To transition from national registration to EAEU rules, the dossier must be brought into compliance with Union’s requirements (regulatory procedure similar to submission of the eCTD baseline dossier).

Kyrgyzstan:

On March 1, 2024, the transition period ended, and mandatory serialization of medicines was introduced in the Kyrgyz Republic. The code can be printed on the packaging during production or applied by a sticker in the GS1 2D Data Matrix format. To facilitate visual control, along with the two-dimensional code, human-readable information (HRI) is also applied, including the mandatory GTIN and unique packaging number, and optionally, the expiration date and batch number. Kyrgyzstan accepts most 2D codes (EU, USA, India, etc.), which can be imported into the national electronic system.

Amendments were made to the Government Resolution of the Kyrgyz Republic dated July 5, 2018, No. 312 “On Approval of the Procedure for Quality Assessment of Medicines,” which allowed until December 31, 2025, the quality control of medicines in packaging different from the registered one, with an applied traceability code. According to the regulatory authority’s clarifications, these changes allow:

• To apply for free of charge changes to the packaging layout, provided that nothing changes in the previously approved layout and only the Data Matrix code is added.
• The import of registered medicinal products in unregistered packaging with an applied Data Matrix code, provided that the layout and instructions are in the official or state language, and the information on the secondary packaging is identical to the registered one.

On January 1, 2024, the transition to the Unified Registration Rules in the EAEU member states took place: submission of applications for new drug registration is only possible under EAEU legislation. Pharmaceuticals registered under national rules can be marketed until December 31, 2025. To transition from national registration to EAEU rules, the dossier must be brought into compliance with Union’s requirements (regulatory procedure similar to submission of the eCTD baseline dossier).

Moldova:

In December 2023, the Agency for Medicines and Medical Devices (AMDM) launched a new application, Med Safety, through which healthcare professionals and patients can report adverse drug reactions. Med Safety is a free smartphone application that allows users to report adverse reactions or effects of medicines to the competent national authorities. The application is available in three languages. It was developed by the WEB-RADR project with the support of the Innovative Medicines Initiative Joint Undertaking (IMI JU) and is funded by the European Union.

Mongolia:

Since January 2024, the address of the Office for the Control and Regulation of Medicines and Medical Devices (the regulatory authority of Mongolia) has changed to: Chingeltei District, 3rd Khoroo, Peace Avenue, Peace and Friendship Palace, Ulaanbaatar 15160, Mongolia (Чингэлтэй дүүргийн 3 дугаар хороо, Энхтайваны өргөн чөлөө, Энхтайван найрамдлын ордон, Улаанбаатар хот 15160, Монгол улс).

Since April 2024, applications for obtaining advertising permits for over-the-counter medicines are submitted through the state platform e-business.mn.

Ukraine:

By the orders of the Ministry of Health of Ukraine (MOH) from May and June 2024, amendments were made to the procedure for confirming compliance of production with GMP requirements, approved by MOH Order No. 1130. The amendments provide for the extension of the Recognition Decision in case of the extension of the GMP certificate by the regulatory authority of the reference country.

On May 14, 2024, amendments to the state registration procedure, approved by CMU Resolution No. 376, came into effect. These amendments mainly consolidated changes previously made to the procedure during martial law.

On April 17, 2024, Cabinet of Ministers of Ukraine Resolution No. 1077 of October 13, 2023, “On Amending Paragraph 31 of the Procedure for State Quality Control of Medicines Imported into Ukraine” came into effect, which canceled the simplification of GMP certificate recognition during the war period.
Accordingly, from April 17, when issuing a quality conclusion for the import of a medicinal product, a conclusion from the State Service of Ukraine on Medicines and Drug Control regarding the compliance of production with GMP requirements must be provided.
From April 17, the import of medicinal products without GMP confirmation is prohibited. Please note that the batch of the medicinal product must be produced during the validity period of the GMP certificate, which was either recognized or issued by the State Service of Ukraine on Medicines and Drug Control.

The gradual implementation of the eCTD format in Ukraine has begun, with corresponding changes to the state registration procedure adopted in October 2023 and April 2024. The test period for submitting dossiers for new registration began in May 2024, and for re-registration and amendments, it began in July and will last until the end of December 2024.
By MOH Order No. 691 of April 23, 2024, requirements for the specification of the electronic common technical document (eCTD) format were approved, including requirements for Module 1 and validation criteria. The requirements for Modules 2-5 of the eCTD format comply with general ICH requirements.
Documents in Module 1 are signed with a qualified electronic signature (QES) of the Applicant’s representative in Ukraine.
The mandatory transition to the eCTD format will take place on August 18, 2025, three years after the adoption of the Law of Ukraine “On Medicines” in the 2022 edition.

On February 16, 2024, the Law on the Regulation of the Circulation of Cannabis-Based Medicines was adopted, which will come into effect on August 16, 2024. The purpose of the Law is to implement best practices in regulating the limited circulation of cannabis, cannabis resin, cannabis extracts and tinctures, as well as tetrahydrocannabinol (THC), its isomers, and their stereochemical variants. The law introduces changes to Ukrainian legislation to create conditions for expanding patient access to necessary treatment and conducting scientific research. Currently, amendments to related regulatory acts are being developed.

We remind you that the State Expert Center of the Ministry of Health of Ukraine conducts planned and targeted audits of MAH’s pharmacovigilance systems. Reasons for a targeted audit may include significant changes in information regarding the pharmacovigilance system, untimely safety updates (updating the instructions for medical use of medicinal products), untimely submission of reports on adverse drug reactions, regularly updated safety reports, submission of documents, etc. A new pharmacovigilance procedure, which will significantly change the current regulation, is also under public discussion. If adopted, we will inform you separately.

Since February 2022, more than 30,000 civilians have fallen victim to the Russian Federation’s military aggression against Ukraine, including over 600 children killed. Civilian infrastructure in Ukraine is attacked daily: residential buildings, hospitals, schools, and critical infrastructure objects are destroyed. At the end of 2023, amendments were made to the procedure for processing humanitarian aid.
We published an article on providing medicines, medical devices, and other humanitarian aid to Ukraine in accordance with the new legislation requirements.

Uzbekistan:

On April 1, 2024, the Senate of the Republic of Uzbekistan approved amendments to the Law “On Medicines and Pharmaceutical Activities,” abolishing the state registration of active pharmaceutical ingredients.

On May 30, 2024, amendments to the Laws “On Health Protection of Citizens” and “On Medicines and Pharmaceutical Activities” were made, assigning the Ministry of Health the authority to determine the procedure for classifying medicines as prescription or over-the-counter, as well as introducing the requirement to indicate this status in the medical use instructions and the state register.

The “Pharmaceutical Product Safety Center” under the Ministry of Health of the Republic of Uzbekistan introduced a mandatory procedure for quality control of ethylene glycol and diethylene glycol content in medicines on March 1, 2024. The Pharmaceutical Product Safety Center developed the General Pharmacopoeial Article (GPA) No. 42 UZ-0015-5346-2023 “Identification and Quantification of Ethylene Glycol and Diethylene Glycol in Medicines.”
Manufacturers need to implement the method for controlling ethylene glycol and diethylene glycol in the regulatory documentation (RD) for the following dosage forms: injections, infusions, soft dosage forms, oral liquid dosage forms, and suppositories, which contain glycerin, propylene glycol, sorbitol, macrogol, polyethylene glycol, and other glycols in production or as excipients. The import of medicines into the territory of the Republic of Uzbekistan without indicating this parameter in the RD for all dosage forms specified in the Order is not possible after March 1, 2024.

Eurasian Economic Union:

On May 6, 2024, by Order No. 70 of the EEC Collegium, amendments were made to the Rules for the Registration and Examination of Medicinal Products regarding changes to registration materials, including:

• The notification period for IA type changes (changes requiring immediate notification) is 20 days from the date of implementation of such changes.
• The process for making simultaneous changes is described.
• The rules for grouping changes are clarified, with a description of the procedure for submitting similar changes to multiple registration dossiers.

On February 20, 2024, by Order No. 15 of the EEC Collegium, changes to the rules for conducting bioequivalence studies of medicinal products were approved. Key changes include:

• Manufacturers now have the option to choose alternative options for purchasing the medicinal product in third countries.
• The use of generic medicinal products as reference products is allowed.
• The requirements for the biowaiver procedure have been updated in accordance with the requirements of the EU, WHO, and countries in America and Asia.

On February 4, 2024, the EEC Council Decision No. 77 of July 4, 2023, “On Amendments to the Rules for Conducting Studies of Biological Medicinal Products of the Eurasian Economic Union” came into effect. In the new edition:

• New chapters (24-30) have been added.
• The need for large-scale therapeutic equivalence studies has been excluded.
• Chapter 15.6 “Preclinical and Clinical Studies of Biosimilar Medicinal Products Based on Low Molecular Weight Heparins” has been updated to comply with the current EMA guideline EMEA/CHMP/BMWP/118264/2007 Rev. 1 (10 November 2016) Guideline on non-clinical and clinical development of similar biological medicinal products containing low molecular-weight-heparins.
• Guidelines on the evaluation of the production process of human plasma-derived products regarding the risk of prion infection and the immunogenicity of therapeutic proteins are provided.

On November 10, 2023, the EEC Council Decision No. 108 “On the Labeling of Medicinal Products with Identification Means” came into effect, according to which EAEU member states must determine the list of medicinal products subject to labeling, the date of introduction, and the procedure for labeling in their territory and notify the EEC no later than 6 months before the introduction of labeling. The decision establishes uniform rules and requirements for the labeling of medicinal products in the EAEU, aimed at increasing the transparency and traceability of medicinal products.
Medicinal products subject to mandatory labeling include those registered under EAEU rules or national legislation, as well as those not subject to registration or unregistered if provided for by law. Responsibility for labeling medicinal products produced in the EAEU lies with the manufacturer, and for imported medicines, with the holder of the registration certificate. Exceptions are provided for veterinary drugs, medicinal products for clinical trials, emergency response products, radiopharmaceuticals, and medical gases.

Labeling specifications:

• A unique sequence of symbols in GS1 Data Matrix format, suitable for machine reading.
• The identification means include data on the product code (GTIN), individual serial number, verification key identifier, and verification code value.
• The labeling is applied to the packaging in a way that does not allow the identification means to be separated without damage.
• Storage of data on labeled products, including GTIN, serial number, product name, production batch information and expiration date, registration certificate, and other characteristics. The system provides access to information for consumers and interested parties through national and integration components.

On October 20, 2023, the EEC Council made changes to the rules for the registration and examination of medicinal products, simplifying the procedure for bringing the registration dossier into compliance with Union requirements, including:

• Indefinite registration is granted if the medicinal product has been registered for more than 5 years in the states where the bringing and subsequent recognition are carried out.
• The submission of certain documents from Module 1, including most documents from section 1.8, has been canceled.
• Changes were made to sections 1.6.1, 1.6.2, 1.6.3 of Module 1.
• When bringing the registration dossier into compliance, it is allowed to make not only changes from Supplement VI to Annex 19 but also unclassifiable IB-type changes, and, if necessary, to harmonize discrepancies in the dossier (indications, sites, etc.) between member states, and it is also allowed to make significant changes according to Supplement V.
• In Module 2, sections 2.3-2.5 may be provided as overview parts with the necessary updates to these sections as appendices to the overviews.
• When bringing for marketing in the territory of one member state, it is allowed to submit Modules 4 and 5 without sections 2.4 and 2.5 of Module 2.
• It is allowed to bring the dossier into compliance regardless of the date of national registration of medicinal products.

On October 3, 2023, the EEC Collegium approved the Guide on Assessing the Significance of Medicinal Products for Public Health for the purpose of accelerated examination during their registration. The guide provides recommendations on writing the application and justifying the significance of the medicinal product for public health, as well as examples.

On September 25, 2023, the EEC Collegium approved changes to the Rules for the Registration and Examination of Medicinal Products for Medical Use. Among the significant changes:

• During the validity of the indefinite registration certificate, periodic benefit-risk assessments will be conducted.
• Updated requirements for the dossier to bring it into compliance with Union requirements.
• The response time to the regulatory authority’s request has been increased from 90 calendar days to 180 working days.
• Indefinite registration is granted if the medicinal product is intended for marketing only in a specific member state.
• It is allowed to make significant changes to the medicinal product’s registration dossier in the reference state during the procedure of bringing it into compliance with Union requirements.

On September 5, 2023, the EEC Collegium presented the Guide on Preparing Module 1 of the Registration Dossier for the Mutual Recognition Procedure and the Decentralized Procedure. The guide describes the requirements for indicating changes initiated before the application submission, cases of submitting the pharmacovigilance system master file, examples of documentation submissions for the decentralized procedure and the mutual recognition procedure.

We remind you that on January 1, 2024, the transition to registration under the Unified Rules took place in the EAEU member countries: applications for new registration of medicinal products can only be submitted under EAEU legislation. Medicines registered under national rules may be marketed until December 31, 2025. To transition from national registration to registration under EAEU rules, it is necessary to undergo the procedure of bringing the dossier into compliance.

Cratia is a professional regulatory consultant for medicines in 11 countries of Eastern Europe and Central Asia: Azerbaijan, Armenia, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Ukraine, Uzbekistan and the Eurasian Economic Union (EAEU).

If you have any questions, we will be happy to answer them by email at info@cratia.com, by phone at +38(044)364-33-55, or at a meeting in our office.