The Ministry of Agriculture approved an order expanding the number of recipients of state support

January 28, 2025.

On January 23, 2025 the Order of the Ministry of Agriculture of the Russian Federation No. 733 dated 12.12.2024 “On Amendments to the list of medicines for veterinary use, feed and food additives, enzyme preparations, the production of which is carried out from products (raw materials) that are not agricultural, approved by the Order of the Ministry of Agriculture of the Russian Federation No. 509 dated September 3, 2024” was published.

In the position “Medicines for veterinary use intended for farm animals, corresponding to the codes of the All-Russian Classifier of Products by Economic Activities 21.10.51, 21.10.54.120, 21.10.54.180, 21.10.60.193, 21.20.10, 21.20.21.110, 21.20.21. 130 (except for vaccines with a storage and transportation temperature of minus 60 degrees Celsius or lower), 21.20.22, 21.20.23.190” the words ‘(except for vaccines with a storage and transportation temperature of minus 60 degrees Celsius or lower)’ are deleted.

Thus, state support will be extended to all manufacturers of veterinary vaccines, including those that require ultra-low storage temperatures.

The document will be effective from 03.02.2025.

Reference: http://publication.pravo.gov.ru/document/0001202501230007

Amendments were made to the Rules for Registration and Expertise of Medicines

January 23, 2025.

The Council of the Eurasian Economic Commission at its meeting on January 22 approved a package of amendments to the Rules for Registration and Examination of Medicinal Products for Medical Use.

The package includes approaches to regulating the registration of medicines whose packaging includes various additional devices, such as administration aids, measuring cups and spoons, means ensuring proper preparation and storage of the medicinal product.

Depending on the type of products included in the package, the manufacturer is obliged to provide in the registration dossier documents confirming the quality and proper performance of the product in dosing and administration of the medicinal product. At the same time, in order to reduce the regulatory burden on applicants, separate registration of such products and devices as medical devices is not mandatory.

The package of amendments also provides for the issuance of a separate registration certificate for each new dosage form of a medicinal product.

Link: https://eec.eaeunion.org

Lists of vital drugs and drugs for the treatment of high-cost nosologies are expanded

January 20, 2025.

On January 20, 2025, the Russian Federation Government Order No. 10-r dated January 15, 2025 was published, amending the List of Vital and Essential Drugs (VED).

This list has been supplemented with new names and dosage forms for the treatment of patients with various oncologic, chronic, autoimmune, cardiovascular and infectious diseases.

The document amends the Government Order No. 2406-r of October 12, 2019. The start of the document is 20.03.2025.

18 medicines are added which are used in the treatment of diabetes mellitus, pneumonia, chronic obstructive pulmonary disease, severe bronchial asthma, tachycardia, lymphoma, melanoma, leukemia, breast cancer, systemic lupus erythematosus, anemia in chronic kidney disease, lipid metabolism disorders, peritonitis, as well as for the prevention of thrombotic complications and during antiretroviral therapy.

These drugs include zanubrutinib, polatuzumab vedotin, nurulimab+prolgolimumab, inotuzumab ozogamicin, alpelisib, anifrolumab, alogliptin+pioglitazone, esmolol, roxadustat, inclisiran, biapenem, atazanavir+ritonavir, fampridine, glycopyrronium bromide + indacaterol+mometasone, beclomethasone + glycopyrronium bromide + formoterol, budesonide + glycopyrronium bromide + formoterol, tazepelumab.

Additional dosage forms were added for four medicinal products contained in the list, namely insulin lispro, daratumumumab, diclofenac and piribedil.

The order supplements the list of drugs for treatment of patients with complex and rare diseases within the framework of the program of 14 high-cost nosologies. The antitumor agent isatuximab, used in the treatment of multiple myeloma, has been added to it.

Link: http://publication.pravo.gov.ru/document/0001202501200014

The State Duma is considering a bill on the list of strategically important medicines

January 13, 2025.

Draft Law No. 811556-8 on amendments to Article 4 of Federal Law No. 61-FZ of 12.04.2010 “On Circulation of Medicines” has been submitted to the State Duma.

The draft federal law proposes to legislate the concept of a list of strategically important medicinal products (hereinafter – SMLPs) and to authorize the Government of the Russian Federation to approve the list of SMLPs, the procedure and criteria for its formation.

The list will include medicines that meet priority healthcare needs. Such drugs should receive priority under the national regime in state procurement.

Strategically important will be those drugs that meet priority health care needs for the prevention and treatment of diseases, including those prevailing in the structure of morbidity in Russia. The drugs included in the list must be manufactured in Russia.

The proposed changes will have a favorable impact on business entities and other economic activities, as they are aimed at ensuring stable demanded production of medicinal products included in the NWLS list, which in turn should guarantee stable availability of jobs at these production facilities and social guarantees.

This law, if approved, should come into force on 01.03.2025.

Link: https://sozd.duma.gov.ru/bill/811556-8

The order of Roszdravnadzor extends the approval procedure for non-original components of medical devices until January 1, 2028

January 10, 2025.

On 31.12.2024 the Order of Roszdravnadzor No. 7239 of 23.12.2024 “On Amendments to Paragraph 2 of the Order of the Federal Service for Supervision in the Sphere of Healthcare No. 2983 of May 16, 2023” came into force, according to which the list of information on non-original components for the maintenance of medical devices and the list of documents for keeping the register of such parts and their manufacturers are prolonged until January 1, 2028.

This list of information was approved by Order No. 2983 dd. 16.05.2023 On approval of the list of documents to be submitted and requirements to their content, the form of the conclusion on the possibility (impossibility) to use components or accessories of a medical device not provided for in their technical and (or) operational documentation of the manufacturer (producer), the list of information on components or accessories of a medical device not provided for in their technical and (or) operational documentation of the manufacturer (producer)

Link: http://publication.pravo.gov.ru/document/0001202412280099

The special procedure for the sale of foreign medicines will be in force until the end of 2025

Jan 08, 2025.

01.01.2025 came into force the Decree of the Government of the Russian Federation from December 28, 2024, No. 1964 “On Amending Resolution of the Government of the Russian Federation No. 593 dated April 5, 2022”, which extends until the end of 2025 the special procedure for the sale of registered foreign medicinal products in Russia.

Thus, it will still be possible to sell foreign medicines not only in Russian, but also in foreign packaging with a label in Russian. This allows to avoid shortages of medicines and disruptions in drug supplies.The decision to sell medicines in foreign packaging is made by a special interdepartmental commission. It includes representatives of the Ministry of Health, Roszdravnadzor, Ministry of Industry and Trade, Ministry of Finance, Federal Antimonopoly Service, Federal Customs Service.

Reference: http://publication.pravo.gov.ru/document/0001202412290013

Simplified procedures for state registration of certain medicinal products are extended until the end of 2027

02 January 2025.

On 26.12.2024 the RF Government Decree No. 1851 dated 21.12.2024 “On Amendments to Certain Acts of the Government of the Russian Federation” came into force, according to which simplified procedures of state registration for a number of medicines and the most popular medical devices are prolonged in Russia until the end of 2027.

This makes it possible to maintain the stability of the market of medicines and medical devices during the period of external sanctions.

The drugs and medical devices that can be registered under the simplified procedure are determined by a special interdepartmental commission. It includes representatives of the Ministry of Health, Roszdravnadzor, Ministry of Industry and Trade, Ministry of Finance, FAS and FCS.

Reference:

http://publication.pravo.gov.ru/document/0001202412260063