November 29, 2024

Lists of medicines and medical devices with a long manufacturing or sales cycle for excise tax calculation are approved

Order of the Ministry of Industry and Trade of Russia No. 5354 dd. 15.11.2024, registered with the Ministry of Justice of Russia on 27.11.2024 No. 80328, approved:

– the list of medicinal products, the duration of the production cycle of which is more than nine months or for which a long period of their realization is required;

– the list of medical devices, the duration of the production cycle of which exceeds nine months or for which a long period of their realization is required.

The Order of the Ministry of Industry and Trade is valid from 01.01.2025

From 01.01.2025 Art. 204 of the Tax Code of the Russian Federation is supplemented by para. 3.5 (Federal Law of 12.07.2024 N 176-FZ).

In accordance with the second paragraph of clause 3.5 of Article 204 of the Tax Code of the Russian Federation in respect of operations recognized as an object of taxation in accordance with subparagraph 20_2 of paragraph 1 of Article 182 of the Tax Code of the Russian Federation, in terms of the use of received (entered) pharmaceutical substance of ethyl alcohol for the production of goods specified in paragraph 11_1 of Article 200 of the Tax Code of the Russian Federation, the duration of the production cycle of which is more than nine months or which require a long period of their sale (according to the lists determined by the Ministry of Industry and Trade), the payment of excise tax is not made on the basis of the following: “Excise tax”.

References:

http://publication.pravo.gov.ru/document/0001202411270005

http://publication.pravo.gov.ru/Document/View/0001202407120009

November 19, 2024

It is planned to introduce state duties for the registration of veterinary drugs

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

The draft law proposes to introduce state duties for the performance by Rosselkhoznadzor of actions related to the registration of medicinal products for veterinary use for the purpose of forming a common market for medicinal products within the Eurasian Economic Union in accordance with the law of the Eurasian Economic Union, in particular for expert examination:

– veterinary medicinal product (means) – RUB 461,000;

– documents for a veterinary medicinal product as part of the veterinary medicinal product registration procedure – RUB 360,000;

– for a veterinary medicinal product in order to confirm the registration of a veterinary medicinal product – RUB 164,000;

– for a veterinary medicinal product within the framework of the procedure for confirmation of registration of a veterinary medicinal product – RUB 149,000;

– for a registration dossier of a veterinary medicinal product and expert examination of samples of a veterinary medicinal product as part of the procedure for amending the registration dossier of a veterinary medicinal product

– RUB 323,000;

  • registration dossier of a veterinary medicinal product without expert examination of samples of a veterinary medicinal product within the procedure for amending the registration dossier of a veterinary medicinal product – RUB 191,000;
  • documents for a veterinary medicinal product as part of the procedure for amending the registration dossier of a veterinary medicinal product – RUB 231,000;
  • documents for the purpose of recognizing the registration of a veterinary medicinal product – RUB 320,000, etc.

The amounts of state fees are also established for making amendments without expert examination of a registration dossier and samples of a veterinary medicinal product, and for making a decision on the possibility of recognizing the registration of a veterinary medicinal product registered within the Eurasian Economic Union in states that have joined the Eurasian Economic Union after the registration of the veterinary medicinal product.

It should be taken into account that the draft federal law prepared is not applicable until it is approved and officially published.

Reference: https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=152473

November 14, 2024

Draft decree of the Government of the Russian Federation on clarifying the procedure for selecting samples for quality control of medicines has been prepared

In order to implement the provisions of Federal Law No. 248-FZ dated July 31, 2020 “On State Control (Supervision) and Municipal Control in the Russian Federation” (hereinafter – Law No. 248-FZ) within the framework of Federal Law No. 170-FZ dated June 11, 2021 “On Amendments to Certain Legislative Acts of the Russian Federation in Connection with the Adoption of the Federal Law ‘On State Control (Supervision) and Municipal Control in the Russian Federation’, the Government of the Russian Federation has developed a draft decree amending the Regulations on the Procedure for Sampling of Samples for Quality Control of Medicines.

The document is expected to enter into force in December 2024.

According to the explanatory memorandum, the draft decree provides for the establishment of standards for the selection of a controlled person from whom samples (specimens) of medicinal products will be taken for the purposes of random quality control. It is assumed that controlled persons will be determined for each constituent entity of the Russian Federation at least once a quarter, and their number will be determined on the basis of at least one random quality control per week, taking into account the criteria and conditions specified in the draft.

In addition, the draft introduces norms to regulate the process of conducting expert examinations and tests in relation to medicinal products in terms of the procedure and time limits for the receipt by experts or expert organizations accredited in accordance with the accreditation legislation of the Russian Federation in the national accreditation system or federal state budgetary institutions subordinate to a state control body of consumables and standard samples required for the twofold reproduction of methods of testing and testing.

In particular, paragraph 58 of the Regulations on Federal State Control (Supervision) in the Sphere of Circulation of Medicines (hereinafter the “Regulations”) is amended, according to which sampling (sampling) of medicinal products is carried out by officials of a state control body (territorial body) in accordance with their official powers and a protocol of sampling (sampling) of medicinal products is drawn up. The form of the protocol shall be approved by the state control body.

It is proposed to supplement the Regulation with a number of new paragraphs.

Clause 641, which establishes that an expert shall, within 3 working days of receipt of samples (specimens) of medicinal products, determine the list and quantity of consumables and standard samples required for the twofold reproduction of quality control methods for a medicinal product and request them from the manufacturing organization or the organization importing the medicinal product into the Russian Federation. In turn, the requesting organizations must provide consumables and standard samples within 30 working days from the date of receipt of the request.

Clause 65, which introduces a 6-month storage period for samples (specimens) of medicinal products for medical use remaining after testing (the exception will be samples, testing, examination of which was carried out by non-destructive analysis). Upon expiry of the said period of time, samples (specimens) that do not meet the requirements of the regulatory documentation (regulatory document on quality) shall be destroyed in accordance with Article 59 of the Federal Law “On Circulation of Medicinal Products”, and if the samples (specimens) meet the requirements and there is a note on the necessity of return in the sampling protocol, the controlled person from whom they were taken shall take the remaining samples (specimens) upon expiry of 6 months, and an act of sample transfer shall be drawn up. Unclaimed samples (specimens) shall be disposed of after 30 calendar days.

It is proposed to amend the risk indicators (Appendix No. 2 to the criteria for assigning objects of federal state control (supervision) in the sphere of circulation of medicinal products for medical use to a certain risk category) assigned for preclinical, clinical trials, retail trade and destruction of medicinal products for medical use, as well as the risk indicators assigned for retail trade, preclinical and clinical trials, storage (except for storage carried out by the Ministry of Health and Social Development of the Russian Federation).

It is also proposed to approve the procedure for determining controlled persons from whom samples (specimens) of medicinal products for medical use will be taken for the purposes of selective quality control.

Reference:

https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=152383

November 8, 2024

Amendments to the procedure for importing narcotic and psychotropic substances have been approved

The Government has amended the rules for importation into and exportation from the Russian Federation of narcotic drugs, psychotropic substances and their precursors. The corresponding Government Resolution No. 1481 dated 02.11.2024 was approved, which was published on the same day on the Official Internet Portal of Legal Information. It amends the Government Decree No. 181 of 21.04.2011.

According to the adopted Decree, the Federal Service for Supervision of Health Care will maintain a register of issued certificates for the import and export of narcotic drugs, psychotropic substances and their precursors, which will be posted on the official website.

The extract from the register will be formed automatically in the form of an electronic document, a QR code will be applied to the extract, by means of which the transition to the page of the register at the site of the department will be provided.

Earlier the draft decree assumed that the register of issued permits would be kept by the Ministry of Internal Affairs.

In order to obtain authorization for the import and export of these substances, the applicant is now entitled to submit applications to the Ministry of Internal Affairs and Roszdravnadzor not only in writing, but also in electronic form via the unified portal (“Gosudservices”) or via the “One Window” information system in the area of foreign trade activities. The commission agreement has been excluded from the list of documents to be attached to the application.

The Ministry of Internal Affairs of the Russian Federation takes a decision to issue or refuse to issue a permit within 15 working days, and Roszdravnadzor – within 5 days. The decision to refuse can now also be obtained in electronic form.

The period within which Roszdravnadzor must correct the information in a certificate if the applicant discovers an error in the information contained in the register of certificates has also been reduced from fifteen to three days. Within a further three days, the Federal Service for Supervision of Health Care enters information on the revocation of a certificate into the register.

In case of import to the Russian Federation and export from the Russian Federation of narcotic drugs, psychotropic substances and their precursors in the course of foreign trade activities with states that are not members of the Customs Union within the framework of the EurAsEC, it is necessary to obtain a one-time license from the Ministry of Industry and Trade of the Russian Federation in accordance with the rules approved by the decision of the EAEU Council No. 125 of 24.11.2023 “On Approval of the Rules for Issuing Licenses and Permits for Export and Import of Goods Included in the Unified List of Goods”. Certificates of these shipments will also be entered into the register of Roszdravnadzor.

Reference:

http://publication.pravo.gov.ru/document/0001202411020025

November 6, 2024

Rules for the formation of lists of medicines with ethanol approved

The Government of the Russian Federation has approved the rules for forming the list of medicines registered in accordance with the rules of the Eurasian Economic Union and (or) the legislation of the Russian Federation, in the production process of which the pharmaceutical substance of ethyl alcohol (ethanol) is used. 02.11.2024 Government Resolution No. 1437 dated 28.10.2024 (hereinafter referred to as the “Resolution”) was published on the official portal of legal information.

Medicinal products for medical use that meet two criteria simultaneously shall be subject to inclusion in the list:

  • the composition of the medicinal product, medicinal product contains ethyl alcohol, the volume fraction of which is more than 20 percent;
  • the instructions to the preparation state that the functional purpose of the alcohol-containing medicinal product is not related to its ingestion, and the physicochemical and organoleptic characteristics of the alcohol-containing medicinal product specified in the regulatory documentation exclude the possibility of its use as a substitute for alcoholic beverages.

The list is formed on the basis of decisions of the commission formed by the Ministry of Health of the Russian Federation to form a list of medicinal products and (or) medicinal preparations registered in accordance with the law of the Eurasian Economic Union and (or) the legislation of the Russian Federation, where the pharmaceutical substance of ethyl alcohol (ethanol) is used as a raw material for the production of which, and on the basis of proposals submitted by manufacturers of medicinal products or holders (owners) of regulatory certificates for the preparations The commission will include representatives of the Ministry of Health, the Ministry of Industry and Trade, the Ministry of Finance, Rosalkogoltabakkontrol, the Federal Antimonopoly Service, Roszdravnadzor, the Federal Customs Service and the Scientific Center for Expertise of Medical Devices.

The decision of the commission may be based on a proposal or information submitted by a member of the commission. According to Article 11 of the Resolution, in case of identification of discrepancies, the commission shall, within 10 working days after the meeting, send a request for clarification of information on paper by postal mail or in electronic form via telecommunication channels, including e-mail. The applicant shall respond to the request within ten working days.

According to Art. 13 of the Decree, meetings of the commission will be held at least once a quarter until the 20th day of the third month of the quarter, if there are proposals received before the 15th day of the third month of the quarter. Proposals received after the 15th day of the third month of the quarter shall be considered at the meeting of the commission in the next quarter.

The list formed on the basis of the commission’s decisions and amendments to the list shall be approved by the order of the Ministry of Health of the Russian Federation and posted on its official website within 10 working days from the date of official publication of the order of the Ministry of Health of the Russian Federation.

This Decree shall enter into force on January 1, 2025.

Reference: http://publication.pravo.gov.ru/document/0001202411020019

November 1, 2024

New interstate standards for specialists in the field of medicine and health care have been approved

GOST 25995-2024 “Electrodes for bioelectric potentials acquisition. General technical requirements and test methods” was adopted by the Interstate Council for Standardization, Metrology and Certification (Minutes of September 30, 2024 № 177-P) and approved by the Order of Rosstandart of September 30, 2024 № 1302-st.

According to Article 1 of this standard, it applies to conductive passive electrodes (hereinafter referred to as electrodes): remote and built-in skin electrocardiographic (ECG electrodes), remote skin electroencephalographic (EEG electrodes), remote skin and needle electromyographic (EMG electrodes), designed to capture bioelectrical potentials. This standard does not apply to fetal electrodes and electrodes used in experimental medicine.

GOST 25995-2024 shall come into effect in the territory of the Russian Federation from July 1, 2025.

GOST IEC 62494-1-2024 “Medical electrical products. Exposure index of X-ray digital systems. Part 1. Definitions and requirements for general radiography” was adopted by the Interstate Council for Standardization, Metrology and Certification (Minutes of August 30, 2024 № 176-P) and approved by the order of Rosstandart of September 30, 2024 № 1305-st.

This standard is identical to the international standard IEC 62494-1:2008* “Electrical medical devices. Exposure index of X-ray digital systems. Part 1. Medical electrical equipment – Exposure index of digital X-ray imaging systems – Part 1: Definitions and requirements for general radiography”, IDT.

As stated in the article “Scope of application”, the standard specifies the requirements for the exposure index for images in digital X-ray systems. The standard applies to digital x-ray imaging systems for general radiography, such as: computer radiography (CR) systems based on the use of stimulated phosphors; systems using solid-state panels; CCD devices (charge-coupled device CCD). Systems for mammographic or dental radiographs are not within the scope of the standard. The standard defines the exposure value for single exposure only. Images formed by multiple exposures (e.g., tomosynthesis, the method of two exposures or many exposures per radiograph) are not included in the scope of the standard.
GOST IEC 62494-1-2024 is put into effect as a national standard of the Russian Federation from July 1, 2025.

References: https://protect.gost.ru/v.aspx?control=8&baseC=6&page=0&month=11&year=2024&search=&RegNum=1&DocOnPageCount=15&id=252072

https://protect.gost.ru/v.aspx?control=8&baseC=6&page=0&month=11&year=2024&search=&RegNum=1&DocOnPageCount=15&id=251782

November 1, 2024

Draft law on the amount of marketing remuneration of pharmacy chains paid by a supplier of medicinal products has been prepared

A draft federal law “On Amendments to Article 54 of the Federal Law ‘On Circulation of Medicines’ has been prepared to limit abuse by pharmacy chains against suppliers of medicines.

The draft law restricts the possibility of pharmacy organizations and wholesale trade organizations receiving non-operating income and proposes that the Government of the Russian Federation be empowered to determine the procedure for establishing the aggregate amount of such remuneration.

As stated in the explanatory note to the draft law, pharmacy chains, monopolizing the retail pharmaceutical market and possessing market power, violate the principle of equality of participants in civil legal relations, impose unequal and unfavorable business conditions on suppliers, arbitrarily charging them money. This leads to a violation of the comprehensive and stable provision of Russian citizens with affordable medicines.

Article 54 regulates issues of wholesale trade in medicines. In practice, an agreement between the parties to a contract for the supply of medicines may provide for the inclusion in its price of remuneration in favor of a pharmacy network in connection with its purchase of a certain quantity of medicines from the supplying organization. The amount of remuneration under such a contract is agreed by its parties and is not taken into account in determining the price of medicines.

It is proposed to amend Federal Law No. 61-FZ dated 12 April 2010 “On Circulation of Medicines” by supplementing Article 54 with a provision stating that the aggregate amount of remuneration payable to an organization engaged in the wholesale trade in medicinal products and (or) retail trade in medicinal products in connection with the acquisition by it from an organization engaged in the wholesale trade in medicinal products of a certain quantity of medicinal products, the cost of providing services for the provision, distribution and supply of medicinal products and medicinal products to the organization engaged in the wholesale trade in medicinal products, the cost of providing services for the provision, distribution and supply of medicinal products to the organization engaged in the wholesale trade in medicinal products, and the cost of providing services to the organization engaged in the wholesale trade in medicinal products.

As the authors point out, the draft law does not contradict the provisions of the Treaty on the Eurasian Economic Union, as well as the provisions of other international treaties of the Russian Federation.

Reference: https://sozd.duma.gov.ru/bill/755616-8