Review of pharmaceutical regulations – June 2025

June 27, 2025

Changes to the rules for importing medicines into Russia have been approved

On June 27, 2025, amendments to the procedure for importing medicines into the Russian Federation came into force, approved by Russian Government Resolution No. 913 of June 18, 2025, “On Amendments to Russian Government Resolution No. 853 of June 1, 2021.”

The changes affect the current regulations approved by Russian Government Resolution No. 853 of June 1, 2021, “On the Approval of Rules for the Importation of Medicines for Medical Use into the Russian Federation and the Repeal of Certain Acts and Individual Provisions of Certain Acts of the Russian Government.” According to the updated regulations, the right to import medicinal products is granted to:

– foreign pharmaceutical manufacturers;

– legal entities acting on behalf of the drug developer.

Supplies are permitted for the following purposes:

– organization of clinical trials;

– state registration procedure;

– expert reviews of drugs intended for the Russian Federation or EAEU countries.

The requirements for justifying the number of imported drugs or pharmaceutical substances included in the package of documents for obtaining a permit have been clarified. The list of grounds for import has been expanded to include the development of new drugs and scientific research.

The requirements for the package of documents confirming the expediency of the volume of imported medicines have been changed. Depending on the purpose of the delivery, the following must be provided:

– an approved test protocol for preclinical studies;

– a detailed scheme for the use of the drug for clinical studies;

– a calculation of the required number of samples for expert evaluation for registration procedures.

For the development of drugs, scientific and other research, the rationale is determined based on the needs of preclinical research and other research during development. It is presented in the form of:

• research plan, which includes the main objectives, methodology, procedures, statistical aspects, organization and planning of research resources (including its stages and parts);
• calculations of the amount of imported drugs for pharmacological and toxicological studies;
• a document confirming the development of the drug (order, technical specifications, program).

For the registration and examination of drugs that will be marketed in the Russian Federation or the EAEU common market, the justification takes into account the need for the drug based on an in vitro comparative dissolution kinetics test. In this case, it will be necessary to submit a justification in the form of excerpts from regulatory documentation (regulatory document on quality) or their drafts containing information on the amount of the drug required to conduct quality tests according to the relevant indicators, in the form of references to pharmacopoeial articles of the state pharmacopoeia, pharmacopoeia articles of the Pharmacopoeia of the Eurasian Economic Union or foreign pharmacopoeias, and in the form of calculations by an expert institution conducting drug expertise

Link: http://publication.pravo.gov.ru/document/0001202506190014

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June 19, 2025

The list of medical goods whose sale and import into Russia is not subject to VAT has been clarified

Decree No. 905 of the Government of the Russian Federation dated June 17, 2025, introduced changes to the list of medical goods whose sale in the Russian Federation and import into the Russian Federation and other territories under its jurisdiction are not subject to (exempt from taxation) value added tax, approved by Resolution of the Government of the Russian Federation No. 1042 dated September 30, 2015.постановлением Правительства РФ от 30 сентября 2015 г. № 1042.

The lists of medical devices that are classified as probing and bougiening instruments, measuring devices for functional diagnostics, devices for replacing the functions of organs and body systems, and prostheses have been expanded.
The clarifications also apply to vision correction lenses and special-purpose clothing for persons with disabilities.
The resolution shall enter into force one month after its official publication, but not earlier than the first day of the next VAT period, i.e., October 1, 2025

Link: http://publication.pravo.gov.ru/document/0001202506170025

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June 10, 2025

A law on the specifics of selling biologically active supplements has been passed

Federal Law No. 150-FZ of June 7, 2025, “On Amendments to Certain Legislative Acts of the Russian Federation,” has been signed.

Amendments concerning the handling of biologically active additives are being made to Federal Law No. 323-FZ of November 21, 2011, “On the Fundamentals of Health Protection of Citizens in the Russian Federation,” and Federal Law No. 29-FZ of January 2, 2000, “On the Quality and Safety of Food Products.”

According to the approved amendments to the law “On the Quality and Safety of Food Products,” medical workers, in accordance with the procedure established by the federal executive authority responsible for developing and implementing state policy and regulatory and legal regulation in the field of health care, in agreement with the federal executive authority authorized to develop and approve state sanitary and epidemiological rules and hygiene standards, shall have the right to prescribe registered biologically active additives included in the list of biologically active additives (registered in the Russian Federation, meeting the criteria of quality and effectiveness depending on the degree of impact on human health, the requirements of the technical regulations of the Eurasian Economic Union, and included in the relevant list) if citizens have indications for their use.

The criteria for the quality of biologically active supplements and their effectiveness depending on the degree of impact on human health, as well as the specifics of regulating the use of such supplements and the specifics of their registration, are established by the Government of the Russian Federation.

The procedure for prescribing biologically active supplements, the list of indications for the use of such supplements, and the schemes for their use are established by the Ministry of Health of Russia in conjunction with Rospotrebnadzor.

Medical workers prescribing biologically active supplements shall be subject to the restrictions established by Part 1 of Article 74 of the Federal Law “On the Fundamentals of Health Protection of Citizens in the Russian Federation.

The federal law also clarifies the provisions of Federal Law No. 149-FZ of July 27, 2006, “On Information, Information Technologies, and Information Protection” in terms of restricting access to information containing offers for the retail sale of biologically active additives, including by remote means, the retail sale of which is prohibited in accordance with legislation on the quality and safety of food products.

Link: http://publication.pravo.gov.ru/document/0001202506070026

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June 5, 2025

A list of medical measuring devices and requirements for their testing has been published

The Russian Ministry of Health has published Order No. 257n dated April 29, 2025, “On the Approval of the List of Medical Devices Classified as Measuring Instruments in the Field of State Regulation of Measurement Uniformity and the Procedure for Testing Them for the Purpose of Type Approval of Measuring Instruments.”

The list of medical devices that are classified as measuring instruments in the field of state regulation of measurement uniformity has not changed.

The order establishes that three medical devices for in vitro diagnostics (photometer, spectrophotometer, photocolorimeter for clinical laboratory diagnostics) are classified as measuring instruments subject to state regulation to ensure uniformity of measurements and are subject to verification.

This order specifies independently registered medical devices, not components.

The document establishes detailed requirements for the information to be included in the application, as well as the content of the program, protocols, and test reports for medical devices. Criteria for successful completion of tests have also been adopted:

– the metrological and technical characteristics of the medical device obtained as a result of testing correspond to those declared;

– the results of testing of the medical device satisfy the requirements of the testing program;

– the testing program, test report with test protocols, and draft description of the type of measuring instruments are drawn up in accordance with the requirements of this procedure. If any of these criteria are not met, the medical device will be considered to have failed the tests. The order also introduces the possibility of submitting applications, exchanging documents, and signing documents with enhanced qualified electronic signatures.

The document shall enter into force on September 1, 2025, and shall remain in effect until September 1, 2031.

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June 3, 2025

The Ministry of Health has developed new rules for storing medicines

The Minister of Health has approved Order No. 260n dated April 29, 2025, which replaces Order No. 646n of the Ministry of Health of Russia dated August 31, 2016, which expired on May 31, 2025 “On the Approval of Rules for the Proper Storage and Transportation of Medicines for Medical Use.”

The new rules for the storage of medicines establish new requirements for pharmacies and wholesalers for the storage of medicines subject to itemized and quantitative accounting in the wholesale sector and pharmacies. In particular, drugs must be placed in rooms and/or storage areas in accordance with the requirements specified on the secondary (consumer) packaging of the drug, taking into account one of the parameters: physical and chemical properties, pharmacological groups, method of administration of drugs, and aggregate state of pharmaceutical substances.

The right to store other pharmacy products in pharmacies along with medicines will be established, as specified in Part 7 of Article 55 of Federal Law No. 61-FZ of April 12, 2010, “On the Circulation of Medicines”: medical devices, disinfectants, personal hygiene items and products, medical utensils, items and products intended for the care of patients, newborns, and children under the age of three, therapeutic, children’s, and dietary foods, biologically active supplements, perfumes, cosmetics, etc.

After registration with the Ministry of Justice, the order will come into force on September 1, 2025.

Link: http://publication.pravo.gov.ru/document/0001202506020062

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June 1, 2025

A law on state regulation of methanol circulation has been adopted

Federal Law No. 108-FZ of May 23, 2025, “On State Regulation of Methanol and Methanol-Containing Liquids,” was adopted by the State Duma on May 20, 2025, and approved by the Federation Council on May 21, 2025. The federal law aims to protect the health, rights, and legitimate interests of citizens, the economic interests of the Russian Federation, and to ensure the safe circulation of methanol and methanol-containing liquids.

The federal law defines the legal basis for the circulation of methanol and methanol-containing liquids, including the scope of the federal law and the relationships to which it does not apply.

It is envisaged that methanol and methanol-containing liquids may only be traded by organizations and individual entrepreneurs whose information is included in the Register of Organizations and Individual Entrepreneurs Trading in Methanol and Methanol-Containing Liquids (hereinafter referred to as the Register) on the basis of a notification received from them regarding the performance of the specified activity. It has been established that persons engaged in the sale of methanol and methanol-containing liquids before September 1, 2025, have the right to submit a notification for inclusion of information about them in the register before November 1, 2025. The formation and maintenance of the Register in the state information system of industry shall be carried out by the federal executive authority authorized by the Government of the Russian Federation.

The Federal Law establishes requirements for the information contained in the Register, grounds for refusing to include information in the Register (excluding information from the Register), as well as cases when persons whose information is not included in the Register have the right to trade in methanol and methanol-containing liquids.

The Federal Law also establishes:

– a ban on the retail sale of methanol and methanol-containing liquids;

– a ban on the sale of methanol and methanol-containing liquids without warning labels on the packaging (containers) indicating the presence of methanol in chemical products and its danger to the life and health of citizens;

– prohibition of the circulation of methanol and methanol-containing liquids without their mandatory denaturation.

The Federal Law grants the Government of the Russian Federation the following powers:

– establishment of a list of methanol-containing liquids to which its action does not apply;

– approval of the procedure for forming and maintaining the Register;

– approving requirements for the storage of methanol and methanol-containing liquids;

– approving the procedure for the destruction of methanol and methanol-containing liquids;

– approving requirements for the denaturation of methanol and methanol-containing liquids, as well as determining cases in which denaturation is not mandatory

Federal law provides for the seizure of methanol and methanol-containing liquids from illegal circulation on the basis of decisions made by authorities and officials authorized in accordance with the legislation of the Russian Federation, the circulation of which is carried out in violation of established requirements, equipment for the production of products using methanol or methanol-containing liquids in cases where it is detected and used in warehouses, production premises belonging to individuals, as well as organizations and individual entrepreneurs, information about which is not included in the Register

The law shall enter into force on September 1, 2025.

Link: http://publication.pravo.gov.ru/Document/View/0001202505230012