February 25, 2025

The Ministry of Health has finalized a document to optimize the procedure of drug expertise

The Ministry has developed amendments to the Order of the Ministry of Health of Russia No. 558n dated August 24, 2017 “On Approval of the Rules for Expert Review of Medicinal Products for Medical Use and Specifics of Expert Review of Certain Types of Medicinal Products for Medical Use (Reference Medicinal Products, reproduced medicinal products, biological medicinal products, biosimilar (biosimilar) medicinal products (biosimilars), homeopathic medicinal products, herbal medicinal products, combinations of medicinal products), forms of expert committee opinions”. (Order).

According to the explanatory note, the bill was prepared in connection with the introduction of the Federal law Federal Law No. 1-FZ dated 30.01.2024 “On Amending the Federal Law ‘On Circulation of Medicines’ and Articles 1 and 4 of the Federal Law ‘On Amending the Federal Law ’On Circulation of Medicines‘ and the Federal Law ’On Amending the Federal Law ‘On Circulation of Medicines’” introduces a register model for the provision of public services in the circulation of medicines. The procedure for expert examination of the recognition of a drug as orphan for its registration is clarified in accordance with the law of the Eurasian Economic Union (EAEU).

Clarifies the procedure for conducting an expert examination of the recognition of a medicinal product as an orphan drug for the purposes of its registration in accordance with the law of the Eurasian Economic Union.

The document stipulates that an expert will be prohibited from requesting materials for the expert examination of medicinal products from an applicant. In case of insufficient materials, the request shall be sent through the Unified State Information System in the field of healthcare. The conclusion will be formed electronically and signed with enhanced qualified electronic signatures. Amendments to the conclusion are not allowed. The accelerated examination procedure will be conducted within the time limit set by the Ministry of Health.

The authors of the draft law propose to establish a period not exceeding 30 working days for the expert examination of documents for determining the orphan status of a medicinal product. The document also clarifies the requirements for documents to be submitted by an applicant.

The Order will come into force from the date of its official publication, except for certain provisions which will come into force from January 1, 2026.

Reference: https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=147377

February 21, 2025

The Ministry of Health expanded the recently approved list of registered drugs with ethanol

The Ministry of Health of the Russian Federation has added pharmaceuticals to the “List of medicines and (or) pharmaceutical preparations registered in accordance with the law of the Eurasian Economic Union and (or) the legislation of the Russian Federation, as raw materials for the production of which (in the process of production of which) the pharmaceutical substance of ethyl alcohol (ethanol) is used”, approved by Order No. 746 of the Ministry of Health of the Russian Federation dated December 28, 2024 (Order).

The list of registered medicines, the production of which uses the pharmaceutical substance of ethanol (ethanol), included 231 items (tinctures, elixirs, suspensions, concentrates, drops, aerosols and sprays).According to the published amendments, from 20.02.2025 the list was supplemented with four new names, and for eight already included medicines the technical characteristics concerning the form of release and packaging parameters were adjusted. The updated list, which initially included 231 names, was supplemented with four new drugs: “Valemidine”, two combination products based on peppermint oil with addition of motherwort tincture (in combination with phenobarbital or ethylbromizovalerian), and noble deer antler extract. In addition, dosage form characteristics and primary packaging parameters were revised for eight existing preparations, including camphor, formyl alcohol, various combinations with peppermint oil, antifungal and antiseptic agents.

The procedure for inclusion of drugs in the list is initiated by drug manufacturers or owners of registration certificates. To be included in the register, medicines must contain ethanol in a concentration above 20% and have a clear indication in the instructions that they cannot be consumed as alcoholic beverages.

Pharmsubstance of ethanol is an excisable commodity from 2025. A system of tax deductions for the use of ethanol in the production of medical drugs and products with an alcohol content of less than 20%, included in a special list of the Ministry of Health, is envisaged to prevent an increase in drug prices.

Businesses that use less than 50,000 decaliters of ethanol per year are entitled to the deduction regardless of the listing of products produced and without the need to provide documentation to prove the intended use of the pharma substance.

Reference: https://minzdrav.gov.ru/ministry/61/10/stranitsa-858/prikaz-ob-utverzhdenii-perechnya-proshedshih-registratsiyu-v-sootvetstvii-s-pravom-evraziyskogo-ekonomicheskogo-soyuza-i-ili-zakonodatelstvom-rossiyskoy-federatsii-lekarstvennyh-sredstv-i-ili-lekarstvennyh-preparatov-v-kachestve-syrya-dlya-proizvodstva-kotoryh-v-protsesse-proizvodstva-kotoryh-ispolzuetsya-farmatsevticheskaya-substantsiya-spirta-etilovogo-etanol

February 12, 2025

Methodological Guidelines for the creation of the EEU Pharmacopoeia were published

The Eurasian Economic Commission has prepared an edition of Methodological Guidelines for the creation of the Eurasian Economic Union Pharmacopoeia and other documents on drug quality control. The Guidelines were developed by the Pharmacopoeia Committee of the Eurasian Economic Union within the framework of the Concept of harmonization of pharmacopoeias of member states, which defines the model and principles of development of the EEU Pharmacopoeia. The Methodological Guidelines are available on the website of the Eurasian Commission:

https://eec.eaeunion.org/upload/files/deptexreg/LSMI/Pharmacopoeia2024.web.pdf

The published documents allow to ensure unified approaches to the development of pharmacopoeial articles of the Union Pharmacopoeia, as well as provide practical recommendations on the preparation and presentation of the texts of drug specifications and regulatory documents on quality stipulated by the acts of the Commission.

Source:: https://eec.eaeunion.org/news

February 10, 2025

The Rules for Determining the Country of Origin of Goods have been extended

The Council of the Eurasian Economic Commission (EEC) extended until December 31, 2025 the effect of Annex No. 1.1 to the Decision of the EEC Council of November 23, 2020 № 105 “On Approval of the Rules for determining the country of origin of certain types of goods for the purposes of state (municipal) procurement”. The annex approves the list of goods whose origin within the Union will be confirmed in accordance with the localization criteria adopted in the CIS. They are approved by the Agreement on the Rules for Determining the Country of Origin of Goods in the Commonwealth of Independent States of 20.11.2009.

In accordance with the document, the Eurasian Register of Industrial Goods of Member States of the Eurasian Economic Union (EAEU) includes (on the basis of the provision of ST-1 certificates) 258 commodity names containing over 7,000 industrial goods. 340 of them are medical devices.

The TPS rules define a unified approach to regulating the issue of determining and confirming the country of origin of goods for public procurement in those EAEU states that have established preferences for domestic suppliers or imposed restrictions on foreign goods.

These rules are aimed at increasing investment attractiveness and the level of localization and expanding cooperation between Eurasian producers.

Link: https://eec.eaeunion.org/news

February 4, 2025

A list of class “G” medical waste has been developed

The Ministry of Health of the Russian Federation has developed a draft decree “On Approval of the List of Class ‘G’ Medical Waste Similar in Composition to Extremely Hazardous and Highly Hazardous Waste (hereinafter, respectively, the draft decree, the List). The draft has been developed in order to fulfill item 3 of the plan-schedule of preparation of normative legal acts of the Government of the Russian Federation necessary for implementation of the norms of the Federal Law dated 08.08.2024 No. 306-FZ “On Amendments to Certain Legislative Acts of the Russian Federation” dated 29.08.2024 No. TG-P12-28223.

The Federal Ecological Operator, which handles hazard class I and II waste, has selected the types of waste corresponding to:

– medical activity;

– pharmaceutical activities;

– activities related to the production of medicines;

– activities related to the use of infectious disease agents and genetically engineered modified organisms for medical purposes;

– activities on production, storage of biomedical cell products.

The List includes wastes by groups, taking into account that the List should not be closed (exhaustive), including taking into account the provisions of the legislation allowing amendments to the Federal Classification Catalog of Wastes (hereinafter – FCCO), approved by the order of Rosprirodnadzor dated 22.05.2017 No. 242.

The list includes 16 groups of wastes of hazard classes I and II in accordance with the FCCO codes, which are medical wastes of class “G”.

The draft resolution is of informational nature and is not applicable until the regulatory act is approved in final form.

If this project is adopted, it is possible to simplify the classification and determination of medical waste to class “G”, which will help to organize its safe destruction or recycling and avoid high fines stipulated by the CAO RF.

Reference:

https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=154209

February 03, 2025.

The Ministry of Health has prepared a draft law on the exclusion of fees for the registration of medical devices from the Tax Code

Signed in 2021 by all member states of the Eurasian Economic Union Protocol on Amendments to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014 (hereinafter respectively – the Agreement, the Union) in the version approved by the Order of the Council of the Eurasian Economic Commission of October 29, 2021 № 20, contains provisions stipulating that a medical device registered in accordance with the procedure stipulated by the legislation of a member state of the Union (except for changes requiring a new registration in accordance with the procedure stipulated by the legislation of the Eurasian Economic Commission of October 29, 2021 № 20)
in the territory of this Member State, as well as amendments to the registration documents of a medical device registered in accordance with the procedure provided for by the legislation of a Member State of the Union (except for amendments requiring a new registration in accordance with the procedure provided for in paragraph 2 of Article 4 of the Agreement) are allowed, if the relevant application is submitted before December 31, 2026.

In addition, on February 13, 2023 all Member States of the Union signed the Protocol on Amendments to the Agreement, which determined the extension of the national registration regime for medical devices until December 31, 2025.

In view of the above, the Russian Ministry of Health has developed a draft federal law “On Amendments to Article 333.32.2 of Part Two of the Tax Code of the Russian Federation”

According to the explanatory note submitted by the authors of the draft law, the purpose of the draft law is to exclude from the Tax Code State duties for the performance of actions by an authorized federal executive body in carrying out State registration of medical devices.

Article 333.32.2 of the Tax Code of the Russian Federation determines the amount of state duty for state registration of medical devices and registration of medical devices intended for circulation within the Eurasian Economic Union (EAEU). The draft law provides for the deletion of the phrase “state registration of medical devices” from the article.

If approved, the changes will come into force from January 1, 2027.

Reference:

https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=154151.