July 31, 2024.

Amendments to the rules for the formation of lists of vital and essential drugs and expensive drugs

Resolution of the Government of the Russian Federation dated July 25, 2024 N 1009 amends the rules for the formation of lists of vital and essential drugs and expensive drugs. The Resolution comes into force from 06.08.2024.

The list of vital and essential medicinal products and expensive medicinal products will be required to specify:

– the method or route of administration of the drug;

– the main or additional element of dosage forms, including the type of release of the active substance (if any).

One of the criteria for forming the list has been clarified: the drug must have proven clinical or clinical and economic advantages, or features of the mechanism of action, or greater safety in the diagnosis, prevention, treatment or rehabilitation of diseases, syndromes and conditions compared to other medicinal products in the treatment of a certain disease or condition.

Changed the rules for the comprehensive evaluation of a drug that is proposed to be listed. The applicant will have the opportunity to finalize the study that he or she submitted in the proposal if it is deemed inappropriate.

The form of the proposal for inclusion of a drug in the lists was supplemented with new information, including information on the target group of patients and on supplies of the drug to the territory of the Russian Federation.

Reference: Decree of the Government of the Russian Federation of 25.07.2024 N 1009

http://publication.pravo.gov.ru/document/0001202407290030

July 26, 2024.

Classification of changes in the registration dossier for a medicine is supplemented with a new position

On July 30, 2024 the Order of the Ministry of Health of Russia comes into force, which approves additions to the classification of changes in the registration dossier for a medicine. Changes in the drug registration dossier that do not require expert examination include changes in drug safety data based on the information of an expert institution posted on the website of the Ministry of Health.

This Order applies to applications submitted to the Ministry of Health after 30.07.2024.

Reference: Order of the Ministry of Health of Russia from 10.06.2024 N 291n

http://publication.pravo.gov.ru/document/0001202407190029

July 15, 2024.

Roszdravnadzor has canceled the regulation on the acceptance of notifications in the sphere of turnover of medical devices

Thus, the regulation on the acceptance of notifications on the beginning of work with medical devices is canceled. Now it will be necessary to submit notifications to each new address. It will be possible to do this through a unified identification and authentication system (public services portal). The abolished regulations did not take into account the conduct of clinical trials of medical devices, their manufacture, assembly, installation, adjustment, use, operation (including maintenance) and repair.

Thus, the regulation on the acceptance of notifications on the beginning of work with medical devices is canceled. Now it will be necessary to submit notifications to each new address. It will be possible to do this through a unified identification and authentication system (public services portal). The abolished regulations did not take into account the conduct of clinical trials of medical devices, their manufacture, assembly, installation, adjustment, use, operation (including maintenance) and repair.

On 31.05.2024, Decree of the Government of the Russian Federation of 28.02.2024 N 219 came into force, which updated the rules for the submission of notifications on the commencement of certain types of activities, including the circulation of medical devices. In accordance with these rules, notifications must be submitted to each new address. Records of submitted notifications are kept in the unified register of notifications on the platform of the unified register of types of control.

Earlier, the Ministry of Health of the Russian Federation (Roszdravnadzor) by its Letter N 04I-879/22 dated August 8, 2022 “On changes in the procedure for importation of medical devices” established a notification procedure for importation of unregistered medical devices for their registration as part of simplification of control. Developers of medical devices for registration in Russia must send notifications to the Service of the importation of specific samples of medical devices.

Reference: Order of Roszdravnadzor of 10.06.2024 N 3430

http://publication.pravo.gov.ru/document/0001202407080027

Decree of the Government of the Russian Federation from 28.02.2024 N 219

http://publication.pravo.gov.ru/document/0001202403010029

July 11, 2024.

The rules for the operation of the system for monitoring the movement of medicinal products are clarified

On July 9, 2024, Resolution of the Government of the Russian Federation dated 06.07.2024 N 922 came into force, which amended the Regulation on the System for Monitoring the Movement of Medicinal Products for Medical Use. Now, when prescription drugs and drugs subject to subject-quantitative accounting are transferred between subjects of circulation, information on the turnover will need to be entered into the monitoring system in a direct order.

Previously, the direct procedure was applied only for drugs with the INN “Ethanol” and drugs containing narcotic drugs, psychotropic substances and their precursors.

In other cases, subjects of drug circulation may choose the procedure for submitting information to the monitoring system: direct or reverse. In the direct order the information is entered by the supplier, and in the reverse order – by the recipient.

Reference: Resolution of the Government of the Russian Federation dated 06.07.2024 N 922

http://publication.pravo.gov.ru/document/0001202407090011

July 09, 2024.

From January 1, 2025, there will be more common pharmacopoeial articles (09.07.2024)

The EAEU Pharmacopoeia was supplemented with sections on biological medicines, their analysis and radiopharmaceuticals. New articles were also included in the existing sections.

Most changes were made to the section “Biological Tests”. Articles have been added to it, including:

– on neurovirulence testing of live viral vaccines (2.1.6.11.);

– on monocyte activation testing (2.1.6.13.);

– mycobacteria (2.1.6.14.);

– flow cytometry (2.1.6.16.);

– immunonephelometry method for the determination of vaccine components (2.1.6.18.).

Also changes were made to the section: “Impurity limit tests”, the section “General texts on microbiology” was added.

The changes will be effective from 01.01.2025.

Reference: Decision of the EEC Collegium of 25.06.2024 N 75

https://docs.eaeunion.org/Pages/DisplayDocument.aspx?s=%7Be1f13d1d-5914-465c-835f-2aa3762eddda%7D&w=9260b414-defe-45cc-88a3-eb5c73238076&l=%7B8a412e96-924f-4b3c-8321-0d5e767e5f91%7D&EntityID=44943

July 02, 2024.

New decree on the approval of rules for the formation and use of digital passports of industrial products

On July 02, 2024 the Resolution No. 896 of June 29, 2024 on the rules of formation and use of digital passports of industrial products in the Russian Federation came into force. Such passports will make it possible to organize information on industrial products manufactured in the country, identify missing items and determine the priority order of state support.

Digital passports will be formed in the State Information System of Industry and will make it possible to improve the product cataloging system. Passport data will be published in the public domain on the Internet. In this regard, customers of industrial products will have the opportunity to select domestic analogs of imported products and choose the best offer.

The Resolution was prepared to implement the new norms of the Federal Law “On Industrial Policy in the Russian Federation” adopted at the end of 2023.

Reference: Resolution No. 896 of June 29, 2024

http://publication.pravo.gov.ru/document/0001202407020025

July 1, 2024.

Labeling rules for certain medical devices are clarified

Resolution of the Government of the Russian Federation No. 860 dated 26.06.2024, which came into force on 28.06.2024, introduces additions to the rules of labeling of a number of medical devices. In particular, from March 1, 2025 participants in the circulation of certain types of medical devices will need to apply means of identification on the packaging of medical gloves, as well as to submit to the information monitoring system information on the application of means of identification and the introduction of medical gloves into circulation.

From March 1, 2025 it will also become mandatory to submit to the information monitoring system information on the withdrawal of certain types of medical devices from circulation, and from September 1, 2025 – information on the turnover of certain types of medical devices.

If there are unsold medical devices as of March 1, 2025, it will be possible to sell them until August 31, 2025 (inclusive) without marking with means of identification or to mark them.

In the latter case, information on labeling should be transferred to the information system and medical devices should be registered in the subsystem of the national catalog of labeled goods. The following data should be indicated therein:

– the full name of the goods;

– product code and trademark (if any);

– quantity in the consumer package;

– size and composition of the product;

– number of the registration certificate for the medical device and the name of the model.

Earlier, according to the project of the Ministry of Industry and Trade, mandatory labeling of medical gloves was planned to be introduced from March 1, 2024.

Reference: Decree of the Government of the Russian Federation from 26.06.2024 № 860

http://publication.pravo.gov.ru/document/0001202406280037

June 28, 2024.

Manufacturers can submit drug instructions to the drug monitoring system until the end of June.

Instructions for the use of a medicine may be voluntarily submitted to the drug monitoring system until June 30 inclusive. It must be up-to-date as of the date of putting the medicine into circulation. The right is vested in:

– in case of production in the Russian Federation – manufacturers who complete the stage of packaging and labeling of medicines;

– in case of production outside the Russian Federation – holders (owners) of registration certificates, their representative offices in the Russian Federation or authorized representatives.

Reference: Resolution of the Government of the Russian Federation of 24.03.2023 N 468

http://publication.pravo.gov.ru/Document/View/0001202303270037

June 21, 2024.

Plans to introduce State duties for the registration of veterinary medicinal products

The Ministry of Agriculture of the Russian Federation has developed a draft Federal Law “On Amendments to Article 333.32.1 of Part Two of the Tax Code of the Russian Federation” (hereinafter – the Draft).

It is proposed to fix in the Tax Code of the Russian Federation state duties (in the amounts from 149,000 rubles to 461,000 rubles) for registration of veterinary medicinal products and expert examination, in particular for:

– conducting an expert examination of the remedy;

– expert examination of documents for the product

– recognizing the registration of the product;

– for making amendments to the registration dossier for the product.

Also proposes to introduce a State duty for making amendments without expert examination of the registration dossier of a veterinary medicinal product and expert examination of samples of a veterinary medicinal product.

Such state duties are being introduced for the first time. If the draft comes into force, it may affect the pricing of veterinary medicinal products.

Ref: Draft Federal Law “On Amending Article 333.32.1 of Part Two of the Tax Code of the Russian Federation”, Project ID: 148457

https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=148457

June 21, 2024.

Lists of precursors of psychotropic and narcotic substances are proposed to be expanded

The Ministry of Internal Affairs proposes to include 29 new precursors in the list of narcotic and psychotropic substances.

2-bromo-1-(2-methylphenyl)propan-1-one and 2-bromo-1-(3-methylphenyl)propan-1-one may be added to List I.

Table I of Schedule IV is planned to include, among others:

– butyl-2-methyl-3-phenyloxirane-2-carboxylate;

– propyl-2-methyl-3-phenyloxyran-2-carboxylate;

– 1-(4-chlorophenyl)propan-1-one;

– 1-(4-ethylphenyl)propan-1-one.

1,1-dimethylethyl-4-oxopiperidine-1-carboxylate and piperidine-4-one are proposed to be added to Table II of Schedule IV.

Earlier it was proposed to include tapentadol in the list of narcotic drugs.

Reference: Draft Resolution of the Government of the Russian Federation “On Amendments to Certain Acts of the Government of the Russian Federation in the Sphere of Control over Circulation of Precursors of Narcotic Drugs and Psychotropic Substances”, Project ID:148151

https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=148151

June 18, 2024.

Amendments to the list of vital and essential drugs and the list of drugs for high-cost nosologies came into force

On June 18, 2024 amendments introduced by the Russian Government Order N 938-r dated 16.04.2024 to the List of Vital and Essential Drugs approved on October 12, 2019 came into force

The following drugs were added to the list of vital and essential drugs:

– cefepime+sulbactam;

– lamivudine+phosphazide;

– tyrosyl-D-alanyl-glycyl-phenylalanyl-phenylalanyl-leucyl-arginine succinate;

– sampeginterferon beta-1a;

– divosilimumab.

Sampeginterferon beta-1a and divosilimumab are prescribed to patients with a chronic disease such as multiple sclerosis. They are also included in the list of drugs for high-cost nosologies. The other drugs are used for viral and bacterial infections.

Reference: Order of the Government of the Russian Federation from 16.04.2024 N 938-r

http://publication.pravo.gov.ru/document/0001202404180020

June 7, 2024.

The Ministry of Industry and Trade proposed to adjust the action plan for the implementation of Pharma-2030

The Ministry of Industry and Trade proposed to revise a number of provisions of the action plan for the implementation of the strategy for the development of the pharmaceutical industry: in particular, to accelerate the updating of the list of socially important medicines (SMLS).

For example, it is proposed to postpone the amendments to the SMLS, which was announced by Ms. Priyezheva, Deputy Minister of Industry and Trade, at the SPIEF session organized by the Association of Pharmaceutical Manufacturers of the EAEU.

Some pharmaceutical manufacturers believe that the list should include new nosologies and remove drugs that are not in current clinical recommendations. The Ministry of Industry and Trade has already sent its proposals for updating the list of NWLS to the Ministry of Health. In their opinion, it is necessary to make a verified assessment of the impact of the second superfluous rule on each international nonproprietary name in the list of over-the-counter drugs.

June 06, 2024.

List of quotas for the production and storage of narcotic drugs expanded

The Government of the Russian Federation has supplemented with new items Section I “Narcotic Drugs” of the state quotas for narcotic drugs and psychotropic substances within which the production, storage, import (export) of narcotic drugs and psychotropic substances are carried out.

Thirteen items with quotas of 100 g were added, including:

– quinoline-8-yl-8-yl-1-pentyl-1H-indole-3-carboxylate;

– quinoline-8-yl ester of 1-benzyl-1H-indol-3-carboxylic acid;

– phencyclidine.

The quota for mephedrone (4-methylmethcathinone) was increased from 0.1 g to 100 g .

These changes will come into force on June 8, 2024.

Reference: Decree of the Government of the Russian Federation from 27.05.2024 N 687

http://publication.pravo.gov.ru/document/0001202405310097

June 04, 2024.

The Government changed the use of electronic signature in the turnover of medical devices, dietary supplements and antiseptics

Government Decree No. 743 “On Amendments to Certain Acts of the Government of the Russian Federation on the Use of Electronic Digital Signature in the Circulation of Goods Subject to Mandatory Marking by Means of Identification” dated 31.05.2024 was published. This normative act amends the rules for the use of electronic signatures in documents for the circulation of medical devices, wheelchairs and biologically active supplements (BAAs).

The document comes into force on September 1, 2024. It outlines changes to the rules for the use of electronic signatures in documents in the circulation of medical devices, wheelchairs and dietary supplements (BAAs).

Now, in order to register in the system for monitoring the movement of medicinal products (MDLP), participants in the turnover of goods will be able to send an application for registration signed with an enhanced qualified electronic signature of a participant in the turnover of goods (previously this could only be done with the signature of the head of an organization or an individual entrepreneur).

According to the amendments, participants in the turnover of goods subject to labeling must have:

– an agreement concluded with an electronic document management operator;

– a hardware and software complex that allows signing documents with a qualified enhanced electronic signature and exchanging them in the monitoring system;

– Enhanced Qualified Electronic Signature (EES);

– remote access to the emission registration device placed in the monitoring system.

The published document also states that electronic documents, which are automatically generated and provided by the participants of the turnover, may be signed by the UES of the participant, which performs the functions of the operator of the relevant information system.

Earlier, the government approved a resolution, according to which the sale of illegal and expired medical devices, as well as wheelchairs through cash registers will be prohibited from March 1, 2025. When scanning the labeling code, the cash register will refer to the labeling system, and if one of the criteria is triggered, it will not be possible to sell the goods.

Reference: Government Decree No. 743 of 31.05.2024

http://publication.pravo.gov.ru/document/0001202405310140

June 01, 2024.

The rules of registration and examination of medicines have been amended

The Council of the Eurasian Economic Commission at its meeting on May 29, 2024 amended the Rules for Registration and Examination of Medicinal Products for Medical Use.

The administrative part of the procedure for making amendments to the registration dossier of a registered medicinal product was updated taking into account law enforcement. The list was expanded and types of amendments to the registration dossier were specified, which do not require expert work and are carried out in a notification procedure.

The decision of the Council of the Commission will make it possible to optimize the execution of procedures by authorized bodies (expert organizations) of the states of the Eurasian Economic Union when carrying out expert work and assessing the registration dossier for different types of amendments to registered medicinal products.

The main amendments concern the rules under which changes are made to a drug’s registration dossier. The amendments come into force on June 29, 2024 and will apply to legal relations arising from March 1, 2024. Thus, this simplified procedure for making changes to the registration dossier of a medicinal product will apply to applications submitted from March 1, 2024.

The procedure for making changes that do not require expert examination and are registered in a notification procedure has been clarified. In particular, in case of change of IAIN type, the notification must be submitted within 20 working days from the date of realization of the change.

In addition, the provisions on the grouping of amendments when submitting documents have been adjusted. The rules on examination when making changes will lose force.

Reference: Decision of the EEC Council of 29.05.2024 N 43

https://docs.eaeunion.org/docs/ru-ru/01544746/err_30052024_43