August 29, 2024

Russian rules of Good Clinical Practice (GCP) within the framework of harmonization with the EAEU legislation are cancelled

From 01.09.2024 the Order of the Ministry of Health of Russia from 29.05.2024 N 274n on invalidation of the Order № 200n from 01.04.2016 “On approval of the Rules of Good Clinical Practice” comes into force.

The order was adopted in connection with the harmonization of national regulation with EAEU law. According to Article 6 of the Agreement on Uniform Principles and Rules for Circulation of Medicines within the EAEU, concluded in Moscow on 23.12.2014, clinical trials (tests) of medicines in the EAEU member states are conducted in accordance with the EAEU Rules of Good Clinical Practice.

The purpose of the Rules of Good Clinical Practice of the EAEU is to establish a uniform procedure for conducting clinical trials of medicinal products, which should help to ensure the functioning of the common market of medicinal products within the Eurasian Economic Union, mutual recognition of these clinical trials by the authorized bodies of the member states of the Union, as well as recognition of clinical trials performed within and outside the Union.

As part of harmonization, other powers of the Ministry of Health will also be changed, including the development of the form of extracts from the state register of medicines, as well as the issuance of permits for the import of unregistered substances for drug development and scientific research. The rules of good laboratory practice, the procedure for forming regdos, rules for rational choice of drug names and requirements for instructions will be abolished.

Good Clinical Practice (GCP) is an international scientific standard for planning and conducting research involving human subjects, as well as for documenting and reporting the results of such research. The basic rules of GCP were adopted in 1964 on the basis of the Declaration of Helsinki of the World Medical Association.

Link: http://publication.pravo.gov.ru/document/0001202407040010

August 20, 2024

The procedure for submission by the Ministry of Health of information on medicinal products for medical use at the request of the Ministry of Industry and Trade of the Russian Federation has been approved

Order of the Ministry of Health of the Russian Federation No. 3554/406n dd. 07.08.2024 approves, in particular, the procedure for submission by the Ministry of Health of the Russian Federation of information on medicinal products for medical use (including if such information constitutes a trade secret) at the request of the Ministry of Industry and Trade of the Russian Federation within the framework of interdepartmental information interaction.

The response must be sent to the Ministry of Industry and Trade within seven days from the date of receipt of the request.

If the information sent contains information constituting a commercial secret, the Ministry of Health will send a notice to the holder or owner of the registration certificate of a medicinal product for medical use to provide it to the Ministry of Industry and Trade.

The Order shall become effective as of 27.08.2024.

Link: http://publication.pravo.gov.ru/document/0001202408160004

August 12, 2024

Amendments have been made to the Federal Law “On Circulation of Medicines”

On August 12, 2024 Federal Law No. 292-FZ dated 08.08.2024 “On Amendments to Article 57 of the Federal Law ‘On Circulation of Medicines’ (hereinafter – Federal Law No. 292-FZ dated 08.08.2024) was published in the ‘Collection of Legislation of the Russian Federation’. Federal Law No. 292-FZ dd. 08.08.2024 provides for amendments to the prohibition of sale of certain medicinal products.Thus, a list of medicinal products prohibited for sale has been drawn up.In particular, sale of medicinal products for medical use in respect of which information on introduction into civil circulation, on circulation or on cessation of circulation has been blocked in the system for monitoring the movement of medicinal products for medical use, as well as medicinal products whose civil circulation is prohibited, is prohibited.
The document will become effective on 01.03.2025.

Link: http://publication.pravo.gov.ru/document/0001202408080094

August 9, 2024

Approval of the form of an extract from the register of authorizations for the production and use of biomedical cellular products

The Ministry of Health of the Russian Federation has approved the form of an extract from the register of authorizations for the production and use of biomedical cellular products (BMCP).

Order No. 245n dated 20.05.2024 was posted on the legal information portal.

The document concerns BMCPs intended for the performance of an individual medical purpose of a product specially produced for an individual patient directly in a medical organization.

The discharge must contain 16 items:

  • name of BMCP;
  • BMCP trade name (if assigned);
  • type of BMPC (autologous, allogeneic, combined);
  • date of authorization for production and use of BMCP;
  • registration number of the authorization;
  • name of the medical organization to which the authorization was granted;
  • location of the medical organization to which the authorization was granted;
  • taxpayer identification number of the authorized medical organization;
  • place of BMCP production;
  • indications for the use of BMCP;
  • contraindications to the use of BMCP;
  • name of works (services) constituting medical activity according to the license granted to the medical organization;
  • date of authorization confirmation;
  • date of making changes in the registry entry;
  • information on changes in the name, address and (or) location of the medical organization to which the permit was granted;
  • date of revocation of the authorization.

The document takes effect on September 1, 2024 and will remain in effect until September 1, 2030.

Link: http://publication.pravo.gov.ru/document/0001202408060001

August 7, 2024.

Draft list of medicines for veterinary use developed

The Ministry of Agriculture has prepared a Draft Order “On Approval of the List of Medicines for Veterinary Use, Feed and Food Additives, Enzyme Preparations Produced from Products (Raw Materials) Other than Agricultural Products” (prepared by the Ministry of Agriculture of Russia on 02.08.2024).

State Duma deputies proposed to reduce the number of areas of activity in which foreigners can be employed: these include, among others, the medical and pharmaceutical industries. Among the reasons cited is the low personal responsibility of foreigners to Russian citizens. Previously, a similar bill has already been rejected.

The Order is planned to include in the list of food additives permitted for use in the production of food products, in accordance with Annex 2 to the technical regulation of the Customs Union “Safety Requirements for Food Additives, Flavorings and Technological Auxiliaries” (TR CU 029/2012).

In accordance with this, it is planned to expand the scope of medicines for veterinary use, feed and food additives, enzyme preparations.

Link: http://regulation.gov.ru/p/149562

August 5, 2024.

Bill on banning foreigners from engaging in pharmaceutical activities

State Duma deputies have proposed to reduce the number of areas of activity in which foreigners may be employed: these include, among others, the medical and pharmaceutical industries. Among the reasons cited is the low personal liability of foreigners to Russian citizens. Previously, a similar bill has already been rejected.

In the State Duma introduced a bill № 685594-8, concerning amendments to Article 14 of the Federal Law “On the legal status of foreign citizens in the Russian Federation”, it tightens the conditions of employment in Russia migrants in a number of industries.

According to the explanatory memorandum, the bill introduces restrictions on the employment of certain types of activity for foreign citizens who have entered the territory of the Russian Federation for the purpose of carrying out labor activities.

In particular, a restriction is imposed on medical and pharmaceutical activities. The quality of medical and pharmacological services is affected by several factors, including: training and practice, as well as correct diagnosis and drug identification.

According to the authors of the bill, “many medical terms differ significantly from the everyday Russian language, which is used for ordinary communication and testing of foreign citizens who have entered the territory of the Russian Federation for the purpose of work”.

In September 2023, the Government approved quotas for 2024 on the share of foreign employees in Russian companies. For pharmacies it is set at 0%, as before. Earlier, the Association of Independent Pharmacies appealed to the Government with a request to allow pharmacies to hire foreign citizens.

There is currently a ban on hiring foreigners to work in pharmacies, which was first adopted in 2013 and has been extended several times since then.

Link: https://sozd.duma.gov.ru/bill/685594-8