March 28, 2025.

Amendments to the list of medical devices intended for use in providing palliative care to patients at home have been prepared

The Russian Ministry of Health has developed a draft order “On Approval of the List of Medical Devices Designed to Support the Functions of Human Organs and Body Systems Provided to Patients in the Provision of Palliative Care for Use at Home”.

According to the explanatory note to the document, the purpose of the draft order is to update the list of medical devices provided for use at home in the provision of palliative care for adults and children (hereinafter – the List) in terms of bringing the List in line with the nomenclature classification of medical devices, formed in electronic form by groups and subgroups of medical devices in accordance with the state register of medical devices and organizations producing medical devices, and the nomenclature classification of medical devices.

It is planned to exclude certain types of nomenclature classification of products from the List.

The document affects such groups of products as:

– Anesthesia and respiratory medical devices;

– Auxiliary and general hospital medical devices;

– Gastroenterology medical devices;

– Medical devices for manipulation/repair of human tissues/organs;

– Rehabilitation and adapted medical devices for the disabled;

– Cardiovascular medical devices;

– Urological medical devices.

It is proposed to replace the medical devices listed in the draft order that are absent in the Nomenclature Classification.
in the Nomenclature Classification of Codes of Types of Medical Devices, to the existing duplicating types, including those available in the State Register of Medical Devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.

Ссылка: https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=155783

March 26, 2025.

Rules for conducting trials of biological medicinal products supplemented

At a meeting of the Council of the Eurasian Economic Union Rules for conducting research into biological medicines of the Eurasian Economic Union were supplemented with two new chapters, which is reflected in the Decision of the Council of the EEC of January 22, 2025 № 13 comes into force on March 26, 2025.

As stated on the EEC portal, the new chapters regulate the development, preparation, confirmation and verification of quality, efficacy and safety of high-tech drugs based on genetically modified somatic cells. This includes special anti-tumor drugs based on specially treated T-lymphocyte killer cells, allowing treatment of resistant forms of tumors.

Reference: https://eec.eaeunion.org

March 20, 2025.

The Ministry of Finance clarifies the procedure for indicating the country of origin of goods in bids for State purchases

The Ministry of Finance of Russia has issued letter No. 24-03-09/24756 dated 13.03.2025 “On the indication of one country of origin of goods in an application for participation in a procurement in accordance with Federal Law No. 44-FZ dated April 5, 2013 ‘On the contractual system in the sphere of procurement of goods, works and services for state and municipal needs’.

The letter provides clarifications on the procedure for specifying the country of origin of goods in applications for participation in public procurement. The clarifications were prepared after the FAS began to file complaints against the winner of the auction, in the registration certificate of which one of the manufacturers of pharmaceuticalsubstances was not domestic.

In its letter, the Ministry of Finance noted that in applications for participation in procurement under the Federal Law of 05.04.2013 No. 44-FZ “On the contract system in the sphere of procurement of goods, works and services for state and municipal needs” it is necessary to indicate only one country of origin of goods. The name of the country of origin of goods, taking into account subparagraph “e” of paragraph 1, paragraph 1, part 2, Article 51 of Law No. 44-FZ, paragraph two, paragraph 1, Article 432 of the Civil Code of the Russian Federation is an essential condition of the contract.

In this regard, uncertainty on the issue of the country of origin of the purchased goods at the time of contract conclusion in view of the indication in the application for participation in the procurement of several countries of origin of goods from which the goods supplied may originate, will mean the lack of agreement on this essential condition, which in turn is the basis for considering the contract as non-concluded, taking into account the provisions of paragraph one of paragraph 1 of Article 432 of the Civil Code of the Russian Federation.

The letter of the Ministry of Finance states that the indication of several countries of origin of goods in the application for participation in the purchase of the Law № 44-FZ is not provided for, and the question of the introduction of the Law № 44-FZ and issued in its implementation of regulatory legal acts of such a possibility in the Ministry of Finance of Russia is not currently considered in connection with the following.

In this case, the application must contain the name of the country of origin of goods in accordance with the All-Russian Classifier of Countries of the World, approved by Resolution of the State Standard of Russia of 14.12.2001 № 529-st “On the adoption and enactment of the All-Russian Classifier of Countries of the World”.

The country of origin of goods is a fundamental condition for the granting of national treatment in the field of procurement and the application of the measures provided for by Resolution of the Government of the Russian Federation No. 1875 of December 23, 2024 “On measures to grant national treatment in the procurement of goods, works, services for state and municipal needs, the procurement of goods, works, services by certain types of legal entities” “protective” measures that do not provide for multiplicity on the issue of the country of origin of goods, and the introduction of such multiplicity would entail the risk of inability to properly implement the relevant ‘protective’ measure.

In its letter, the Ministry of Finance emphasizes that the rules for the state registration of medical devices, which allow for the indication of several places of production, do not regulate the conclusion of contracts under Federal Law No. 44-FZ dated 05.04.2013 “On the Contract System in the Sphere of Procurement of Goods, Work and Services for State and Municipal Needs”.

Reference: https://minfin.gov.ru/ru/document?id_4=311575-pismo_minfina_rossii_ot_13.03.2025__24-03-0924756_ob_ukazanii_odnoi_strany_proiskhozhdeniya_tovara_v_zayavke_na_uchastie_v_zakupke_v_sootvetstvii_s_federalnym_zakonom_ot_5_aprelya_2013_g.__44-fz_o_kontraktnoi_sisteme_v_sfere_zakupok_tovarov_rabot_uslug_dlya_obespecheniya_gosudarstvennykh_i_munitsipalnykh_nuzhd

March 6, 2025.

The Ministry of Health has submitted amendments to the rules of putting medicines into circulation

The Ministry of Healthcare has developed a draft decree of the Government of the Russian Federation “On the procedure for putting medicines for medical use into civil circulation”. Starting from September 2024, manufacturers are obliged to confirm the quality of each series of pharmaceutical substances in Roszdravnadzor. The new rules concern the procedure for putting into circulation both finished dosage forms and pharmaceutical substances.

According to the new document, the applicant must submit to the federal agency within a period not to exceed 90 business days from the date of receipt of the request the requested drug samples, samples for reproduction of quality control methods, and details of the document confirming payment for testing services. In the previous version of the regulations, this period was 30 working days.

If the time limit is exceeded due to the need to purchase and (or) import samples for reproduction of quality control methods into the Russian Federation, the applicant sends a corresponding application with the necessary documents. The Federal agency shall, within 3 working days from the date of receipt of the application for extension of the time limit, consider it and extend the said time limit, not exceeding 45 working days (in the previous version, the maximum extension period was 30 working days).

If it is necessary to obtain evidence confirming the indicators of environmental conditions, quality of reagents and materials used, quality and conditions of keeping laboratory animals, as well as documents on qualification of testing equipment, primary data from the equipment, technical records related to the test conducted, after the test conducted using means of remote interaction, the period specified in this paragraph may be extended for no more than 30 working days (previously – 20 working days).

The draft decree also provides that within 3 working days from the date of receipt by the automated information system of the Federal Service for Supervision in the Sphere of Healthcare, the Service shall place on its official website, subject to the requirements of the legislation of the Russian Federation on commercial and other secrets protected by law, information on series or batches of medicinal products being introduced into civil circulation.

Once approved, the document will come into force 10 days after the official publication and will be valid for 6 years.

Reference: https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=155073

March 03, 2025.

Changes in the procedure for registration of medical devices in the Russian Federation

From 01.03.2025 changes to the procedure of state registration of medical devices in case of their defect or risk of its occurrence, provided by the Decree of the Government of the Russian Federation from 28.02.2025 № 240 came into effect.

The requirements for documents have been simplified: applications and accompanying materials can be submitted to an expert institution or a registration authority in electronic form via Gosuservices.

Now the fact of registration is confirmed by a registry entry in the State Register, rather than by a registration certificate.

A simplified registration procedure has been introduced for low-risk medical devices until January 1, 2028. In addition, the powers of manufacturers and their representatives have been clarified, including the procedure for making changes to the registration dossier.

The requirements to the documents submitted for registration of medical devices or amendments to the registration dossier have been established. They must be in multicolor format with a resolution of at least 300 dpi in pdf format with a text layer with the ability to select and copy blocks, as well as search.

The size of any one file of the registration dossier shall not exceed 100 MB.

Each document contained in the registration dossier must include the date of issuance.

All documents shall be signed with an electronic signature.

The procedure for making amendments to a registration dossier for a domestic medical product has been supplemented. If incompleteness or unreliability of documents or information is detected, a request will be sent to the applicant for a response within 30 working days.

Medical devices with a low degree of potential risk of use (except sterile), which the interdepartmental commission has included in the list, are registered once for one product name of one manufacturer.

State registration of a medical device or amendments to the registration dossier will be carried out according to the previous rules if the documents were submitted before 01.03.2025.

Ссылка: http://publication.pravo.gov.ru/document/0001202502280066