September 27, 2024

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

By the order of Rosstandart of September 3, 2024 № 1163-st the interstate standard GOST ISO/TS 37137-1-2024 “.

The standard establishes requirements for assessing the biological effect of medical devices in the biological risk assessment process based on ISO 10993-1. The standard provides explanations of the terms “absorb”, “degrade” and other related terms (see Annex A).

GOST ISO/TS 37137-1-2024 is introduced in the Russian Federation from March 1, 2025.

GOST ISO/TR 21582-2024 “Medical devices. Evaluation of biological effect of medical devices. Principles and methods of research on pyrogenicity” was approved by the order of Rosstandart of September 9, 2024 № 1188-st.

The standard establishes the principles and methods of research on pyrogenicity of medical devices and their materials.

GOST ISO/TR 21582-2024 comes into effect in the territory of the Russian Federation from March 1, 2025.

September 17, 2024.

A new risk indicator has been approved for work with agents of dangerous infections

The Ministry of Health of the Russian Federation has developed a new risk indicator for violation of mandatory requirements when using pathogens of infectious diseases of humans and animals (except if the above activity is carried out for medical purposes) and genetically engineered modified organisms of III-IV degree of potential danger, carried out in closed systems (approved by Order No. 702 of 19.12.2023).

The corresponding Order No. 419n dated 15.08.2024 was published on 13.09.2024 on the portal of legal information.

The list of risk indicators, approved in January 2024 and containing three items, is supplemented with a fourth indicator: which is the receipt of an application to the licensing authority within a year:

– on granting a license to carry out activities in the field of use of pathogens of infectious diseases of humans and animals and genetically engineered modified organisms of III-IV degree of potential danger, carried out in closed systems

– or on making changes to the register of licenses from a license applicant who owns by right of ownership or other legal basis technical means and equipment (having identifying features) necessary for carrying out activities, provided that the licensing authority has not received an application for termination of activities from the licensee.

The document is valid until September 1, 2028.

Link: http://publication.pravo.gov.ru/document/0001202409130014

September 10, 2024

The Ministry of Health has prepared amendments to the bill on prescribing dietary supplements to patients for drug therapy and on testing dietary supplements for efficacy

According to Izvestia, the Ministry of Health has prepared amendment proposals for the second reading of the bill on prescribing dietary supplements to patients for drug therapy and on out-of-court blocking of websites selling banned dietary supplements.

Bill No. 638771-8 “On Amendments to Certain Legislative Acts of the Russian Federation” was drafted by the Government in October 2023 and sent for revision several times. The document was adopted in the first reading in July.

The bill proposes to supplement the Federal Law “On the Quality and Safety of Foodstuffs” with provisions on the new powers of the Government of the Russian Federation to establish criteria for the quality of biologically active additives and raw materials for their manufacture depending on the degree of their impact on human health, as well as the conditions for their provision, including in relation to biologically active additives produced on the territory of the Russian Federation, and also to establish the specifics of the use of biologically active additives on the territory of the Russian Federation.

The Ministry of Health believes that if a list of authorized dietary supplements is created and it is allowed to prescribe them to patients, those supplements that have confirmed their medicinal efficacy are required. The Ministry will instruct expert organizations to evaluate studies confirming the effects of dietary supplements.

The Ministry believes that the document contains disagreements with the EAEU norms – federal executive bodies should sort out this issue before the next meeting of the commission.

Link: https://sozd.duma.gov.ru/bill/638771-8#bh_histras

September 6, 2024

The list of interchangeable medicinal products in the register of medicinal products has been supplemented

The portal of the State Register of Medicinal Products (GRLS) (https://grls.rosminzdrav.ru/default.aspx) contains an updated list of interchangeable medicines, information from which should be used when prescribing treatment and consulting consumers about analogs of medicines with the same international nonproprietary name.

The new version prepared by the Scientific Center for Expertise of Medical Devices of the Ministry of Health of the Russian Federation includes 605 international nonproprietary names and 3080 trade names.

As provided by the Federal Law of 27.12.2019 N 475-FZ, this list is supplemented.

For each name of the drug included in the list, data on the manufacturer, dosage and possible contraindications are indicated.

All interchangeable drugs are grouped into 7 groups:

– identical interchangeable;

– unauthorized interchangeables;

– reference interchangeable;

– combined interchangeable;

– reproduced interchangeable;

– drugs recognized as interchangeable in the process of their state registration before March 1, 2020;

– medicinal products registered based on the results of bioequivalence studies or therapeutic equivalence studies in relation to non-reference medicinal products.

September 4, 2024.

Application for authorization to produce BMCP can be submitted via Gosudeservices

Resolution of the Government of the Russian Federation No. 1166 dated 29.08.2024 amends Resolution No. 1184 dated 03.10.2018 “On Approval of the Regulation on Licensing of Activities for the Production of Biomedical Cellular Products”.

The document comes into force from the date of official publication.

According to the Resolution of the Government of the Russian Federation No. 1166, the Regulation on licensing of activities for the production of biomedical cellular products (BMCP) is extended until September 1, 2030.

Applicants have been given the opportunity to submit an application for authorization to produce individual BMCPs via the Gosuslug portal.

Link: http://publication.pravo.gov.ru/document/0001202408290044

September 2, 2024.

Updating of Roszdravnadzor’s Regulations on the Issuance of Authorization for Online Retail Sales of Medicines

Roszdravnadzor has prepared a draft order approving the Administrative Regulations of Roszdravnadzor for the provision of the state service “Issuance of authorization for retail sale of medicinal products for medical use by remote means”.

When an applicant applies for the issuance of a permit for retail sale of medicinal products for medical use by remote means, the results of the provision of the Service are:

1) authorization to carry out retail sale of medicinal products for medical use by remote method;

2) notification of refusal to issue an authorization;

3) registry entry made in the “Register of authorizations for retail sale of medicinal products by distance selling”.

The new regulations provide for three options for providing the service:

“Issuance of authorization for retail sale of medicinal products for medical use by remote method”;

“Introduction of amendments to the register of authorizations for retail sale of medicinal products for medical use by remote means”;

“Termination of an authorization for retail sale of medicinal products for medical use by distance selling”.

The document also takes into account changes in the requirements for market participants to obtain public services. The restriction on the term of validity of a pharmaceutical license was excluded.

If the new regulations are approved, Roszdravnadzor Order No. 7338 of 04.08.2021 “On Approval of the Administrative Regulations of the Federal Service for Supervision in the Sphere of Healthcare for the Provision of the State Service for Granting Permission for Retail Sale of Medicinal Products for Medical Use by Remote Method” will be invalidated.

Link: http://regulation.gov.ru/p/150204

September 1, 2024.

Amendments to the Regulation on licensing of production of medicines

On 01.09.2024, Resolution of the Government of the Russian Federation No. 56 dd. 24.01.2024 entered into force, which amends the Regulation on licensing the production of medicines.

In particular, the license requirements for the licensee are specified.

An application for the granting of a license will be formed by filling in an interactive form posted on the unified portal of public services.

Information confirming the certification of an authorized person of a manufacturer of medicinal products for veterinary use will be requested by the licensing authority using interdepartmental information interaction.

Link: http://publication.pravo.gov.ru/document/0001202401240042