Amendments to the list of medical devices not subject to VAT have been developed

28 April 2025.

The draft Government Decree “On Amendments to the Decree of the Government of the Russian Federation of September 30, 2015 № 1042”, developed by the Ministry of Health of Russia, is on public discussion. The document introduces amendments to the Resolution of the Government of the Russian Federation No. 1042 dated September 30, 2015 “On Approval of the List of Medical Goods, the sale of which on the territory of the Russian Federation and the importation of which to the territory of the Russian Federation and other territories under its jurisdiction are not subject to (exempt from) value added tax”.

The main changes to the list introduced by this document are:

1) changes in the codes of OKPD 2:

  • in position 6 (probing, drilling instruments) replace the code “32.50.11.110” with the codes “22.21.29.120”, “32.50.11.110”;
  • in position 9 (measuring instruments for functional diagnostics), add the code “26.60.12.140”;
  • in position 14 (devices and apparatus for treatment, anesthesia), add codes “32.50.22.191” and “8509.80.000 0”;
  • in position 43 (prostheses) replace the codes “32.50.23.110”, “32.50.23.111”, “32.50.23.112”, “32.50.23.113”, “32.50.23.114”, “32.50.23.119”, “32.50.23.120” with the code “32.50.23”.

2) new wording:

  • Item 22 – lenses for vision correction;
  • Item 35 – clothing for disabled persons for special purposes, made to individual orders.

If approved, the Government Resolution will enter into force one month after its official publication, but not earlier than the first day of the next tax period for value added tax, i.e. the first day of the quarter.

Pharmacy activities will be assigned to the new OKVED code

April 16, 2025

The Federal Agency for Technical Regulation and Metrology has approved an order with amendments to the All-Russian Classifier of Economic Activities (OKVED-2). Order on approval of changes in OKVED 2 to the All-Russian Classifier of Economic Activities (OKVED), signed on 09.04.2025 by the head of Rosstandart, will come into force from June 1, 2025.

The State Duma Committee on Health Protection made a proposal to change OKVED-2 with regard to the activities of pharmacy organizations in February 2024 in its written appeal to the head of the Ministry of Economic Development of the Russian Federation. It was proposed to adjust the definition of the activities of pharmacy organizations and change its code in OKVED-2 to 86.90.5 “Activities of pharmaceutical organizations (pharmacy organizations) and other organizations carrying out activities in the field of health protection”.

According to the adopted order of Rosstandart, the activity of dispensing medicines for medical use is excluded from the code 47.73 “Retail trade in medicinal products in specialized stores”.

This grouping of activities will include retail trade in medicinal products.

The code 86.90.9 (activities in the field of medicine other, not included in other groupings) will be added “pharmaceutical activities in terms of dispensing and manufacturing of medicines for medical use, including radiopharmaceutical medicines for medical use,” the document said.

Class 86 “Activities in the field of health care” in accordance with paragraph 33 of Article 4 of Federal Law No. 61-FZ of 12.04.2010 “On Circulation of Medicines” provides for pharmaceutical activities in terms of dispensing and manufacturing of medicinal products for medical use, including radiopharmaceutical medicinal products for medical use by pharmacy organizations, veterinary pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities.

Ministry of Health renews the regulation on the commission on defective drugs

April 8, 2025

Order of the Ministry of Health No. 128n dated March 17, 2025 “On Approval of the Regulations on the Interdepartmental Commission for Determination of Defectiveness or Risk of Defectiveness of Medicinal Products in Connection with the Introduction of Restrictive Economic Measures in Relation to the Russian Federation and Forms of Conclusions of the said Interdepartmental Commission on Determination of Defectiveness or Risk of Defectiveness of Medicinal Products for Medical Use with Indication of Names (international generic, or chemical, or grouping), their forms, dosages, availability of therapeutic analogs, required volumes for the purposes of importation into the Russian Federation and in other cases of circulation of medicinal products, on the possibility (impossibility) of issuing a permit for temporary circulation of a series (batch) of a medicinal product that is not registered in the Russian Federation, which has medicinal products registered in the Russian Federation analogues by international non-proprietary name and authorized for medical use in foreign countries by the authorized bodies of the respective foreign countries, and on the possibility (impossibility) of transportation, sale, transfer and until the expiration date of storage, dispensing, retail trade (including by remote method), use of medicinal products registered in the Russian Federation in packages intended for circulation in foreign countries”.

According to the order, defective medicinal products for medical use must be included in the relevant list within 10 working days from the date of the commission’s decision. The commission decides not only on the determination of defectiveness, but also on authorization for temporary use of unregistered drugs if they have analogues in Russia. The commission also determines the possibility of selling and using drugs in packaging intended for other countries and cancels previously issued authorizations if the deficiency is eliminated.

The grounds for the decision of the interdepartmental commission to determine a defect or the risk of defect with respect to a medicinal product is the establishment of a deficiency or absence of a medicinal product in circulation in the Russian Federation, the need for which is unsatisfied, with the possible presence of one or more of the following criteria:

  • the manufacturer or supplier has ceased operations;
  • cessation of activity or refusal to supply or risk of cessation of activity of the manufacturer and (or) supplier of excipients included in the pharmaceutical substance and (or) medicinal product, resulting in suspension or cessation of production of medicinal products or their import into Russia;
  • the medicine has been deregistered in Russia;
  • there is a conclusion of Roszdravnadzor on shortage;
  • there are no therapeutic analogs of the drug in the Russian Federation.

The composition of the interdepartmental commission is formed of representatives of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Federal Customs Service, the Federal Service for Supervision of Health Care, the Ministry of Finance of the Russian Federation, the Federal Antimonopoly Service, as well as other interested federal executive bodies and is approved by order of the Ministry of Health of the Russian Federation, totaling at least 11 persons. Other specialists (experts) of institutions may be involved without the right to vote.

Information about the drug in respect of which a proposal to recognize defectiveness has been received is published in the register on the website of the Ministry of Health in the “Journal” section for authorized users no later than six working days before the meeting. Subjects of drug circulation may participate in the discussion of the commission when sending information about it no later than three working days prior to the meeting.

The Commission meets as necessary, but no later than 20 days after the submission of documents. Decisions are made by majority vote, however, unanimity is required for some issues. The results are formalized in the form of conclusions and published on the website of the Ministry of Health.

The decision to cancel the deficiency in case of its elimination is made not earlier than 9 months after the inclusion of the drug in the list of defective drugs.

The start of the document is 15.04.2025.

The term of the document is limited to December 31, 2027, except for certain provisions effective through December 31, 2025.

Reference: http://publication.pravo.gov.ru/document/0001202504040010

The list of interchangeable drugs has been updated

April 04, 2025.

The Russian Ministry of Health has prepared an updated list of interchangeable medicinal products, which is available on the website of the State Register of Medicinal Products (GRLS).

The list includes six thematic lists, it was formed in accordance with Federal Law No. 475-FZ of 27.12.2019 on Amendments to the Federal Law “On Circulation of Medicines” and the Federal Law “On Amendments to the Federal Law ‘On Circulation of Medicines’.

The supplemented list of interchangeable medicines includes 631 international nonproprietary names (INN) and 3,353 trade names (TN).

The following were added to this document of the Ministry of Health:

  • a list containing reference medicinal products having the same INN, equivalent dosage forms and equivalent qualitative and quantitative characteristics of pharmaceutical substances or comparable antigenic composition of vaccines, as well as the same indications and contraindications for use (clause 4 part 4 of Article 3 of Federal Law No. 475-FZ dated 27.12.2019, clause 8 of Resolution No. 1360 of the Government of the Russian Federation dated September 5, 2020 “On the Procedure for Determining the Interchangeability of Medicinal Products for Medical Use”);
  • list of interchangeable combined medicinal products (containing a combination of two or more active substances) p.1 part 4 article 3 of Federal Law No. 475-FZ dated 27.12.2019;
  • the list of interchangeable medicinal products for medical use stipulated by No. 61-FZ. This list contains 694 INN, 4,463 TH analogs and 944 TH reference drugs;
  • the register of drugs registered before the issuance of No. 475-FZ of December 27, 2019;
  • a list in which drugs registered on the basis of the results of bioequivalence studies or therapeutic equivalence studies in relation to non-reference medicinal products are immersed.

The following international nonproprietary names have been added to the list:

  • avatrombopag;
  • bempedoic acid;
  • dydrogesterone;
  • iron carboxymaltosate;
  • zonisamide ivacaftor+tezacaftor+exacaftor and ivacaftor;
  • ixabepilone;
  • interferon alpha-2b;
  • interferon beta-1b;
  • lacosamide;
  • loxoprofen;
  • mecobalamin;
  • arsenic trioxide;
  • obeticholic acid;
  • ranibizumab;
  • regorafenib;
  • remifentanil;
  • riddiplam;
  • ruxolitinib;
  • saxagliptin;
  • silodosin;
  • tedizolid;
  • temgicoluril;
  • tirzepatide;
  • tocilizumab;
  • fabomotisol;
  • empagliflozin;
  • ethambutol;
  • etifoxin;
  • etinaconazole.

Ciclopirox, acetazolamide, biapenem, tetramethyltetraazabicyclooctandione were removed from the list.

The list is compiled by the Ministry of Health taking into account the presence of bioequivalence or therapeutic equivalence studies to the reference drug in the registration dossier.

According to the Resolution of the Government of the Russian Federation No. 1357 dated September 4, 2020 “On Approval of the Rules for the Use of Information on Interchangeable Medicinal Products for Medical Use and Explanation of Interchangeability of Medicinal Products for Medical Use, as well as on Amendments to the Specifics of Description of Medicinal Products for Medical Use, which are the subject of procurement to ensure state and municipal needs”, the property of drugs is determined on the basis of bioequivalence studies. Physicians and pharmacists in their work use information on interchangeable reproduced medicines and bio-analogs, and a wider choice of interchangeable medicines within one international nonproprietary name creates competition between manufacturers whose medicines are included in the list.

Link: https://grls.rosminzdrav.ru/ForumTopic.aspx?idTopic=13820