The regulation of the circulation of medical products is changing
Pepeliaev Group advises that on 30 April 2021 Federal Law No. 128-FZ “On amending the Federal Law “On the fundamentals of health protection in the Russian Federation” and articles 12 and 22 of the Federal Law “On licensing individual types of activity”[1] was adopted, which substantially amends the regulation of the circulation of medical products.
The amendments will come into force after 10 days from when the Law was published and apply to the registration procedure and the circulation rules for medical products, to the licensing of activities relating to the production and maintenance of medical products, as well as to the monitoring of the safety of such products and state control.
In particular the amendments made eliminate the discrepancies arising between Law No. 323-FZ[2], other regulations of the Russian Federation, and EAEU regulations within the framework of the transition to a common market of medical products. Similarly to the legislation on the circulation of medicines, they also introduce separate regulation of the circulation of certain types of unregistered medical products, which is in demand owing to medicine’s personalised nature.
The changes made eliminate a gap in legal regulation and provide direct answers to the old practical questions concerning the relationship between the term of validity of a registration certificate (RC) or the data in the registration dossier and the service life (shelf life) of the medical products released into circulation. Now a medical product is directly allowed to circulate during its service life (shelf life) regardless of the fact that its RC has expired, or regardless of the fact that such medical product was produced in accordance with the information in the old registration dossier, but within a limit of 180 calendar days from the date when the dossier was amended.
The following items have been added to the list of medical products that are not subject to state registration:
The Law unifies and introduces an individual regulation for the specified unregistered medical products. Such regulation will be determined by regulations of the Government of the Russian Federation and the authorised federal executive authority (the Ministry of Healthcare of the Russian Federation).
At the same time, the licensing regime for activity relating to the technical maintenance of medical products will be retained: starting from 1 January 2022 the holders of licences for the production and technical maintenance of medical devices will be obliged to have such licences reissued with respect to technical maintenance before 1 January 2024 as licences for activity relating to the technical maintenance of medical devices. In the event that a licence is reissued, the licensee will not be checked for compliance with the licensing requirements if the licensee does not amend the list of work performed or services provided.
Moreover, on 1 January 2021, Resolution No. 1445[3] of the Russian Government dated 15 September 2020 came into force establishing a requirement to have all of the licences that have been issued before 1 January 2021 reissued before 31 December 2023. This Resolution also enacts that one of the documents that an applicant needs to provide when obtaining a licence is a certificate of conformity to the requirements of inter-state standard GOST ISO 13485-2017.
We believe that based on the current version of the amendments, starting from 1 January 2022 Resolution No. 1445 should not apply to the licensing of activity relating to the production of medical products. Therefore, the following questions now already arise: (1) how and according to what procedure will an inspection be carried out with respect to companies which by that time will have had a licence reissued in accordance with the new requirements of the Russian Government’s Resolution No. 1445 and will have the required certificate of conformity; (2) does it make sense for companies that have not yet had a licence reissued to have a licence reissued that was obtained before 1 January 2021; (3) according to what procedure will sites on which various medical products are manufactured be inspected for the potential risk inherent in their application.
The amendments will come into force after 10 days from when the Law was published and apply to the registration procedure and the circulation rules for medical products, to the licensing of activities relating to the production and maintenance of medical products, as well as to the monitoring of the safety of such products and state control.
In particular the amendments made eliminate the discrepancies arising between Law No. 323-FZ[2], other regulations of the Russian Federation, and EAEU regulations within the framework of the transition to a common market of medical products. Similarly to the legislation on the circulation of medicines, they also introduce separate regulation of the circulation of certain types of unregistered medical products, which is in demand owing to medicine’s personalised nature.
The changes in the registration and circulation procedures for medical products
The provisions of the previous version of Law No. 323-FZ on the state registration of medical products and the relevant state duty, on maintaining the state register of medical products and producers of medical products, as well as the definition of “an inferior medical product” have been brought in line with the EAEU’s regulations.The changes made eliminate a gap in legal regulation and provide direct answers to the old practical questions concerning the relationship between the term of validity of a registration certificate (RC) or the data in the registration dossier and the service life (shelf life) of the medical products released into circulation. Now a medical product is directly allowed to circulate during its service life (shelf life) regardless of the fact that its RC has expired, or regardless of the fact that such medical product was produced in accordance with the information in the old registration dossier, but within a limit of 180 calendar days from the date when the dossier was amended.
The following items have been added to the list of medical products that are not subject to state registration:
- medical products imported into the Russian Federation for the purpose of organising medical treatment for a specific patient to maintain his/her vital functions based on a licence issued by the Federal Service for Surveillance in Healthcare (Russian acronym - Roszdravnadzor);
- medical products originating in the Russian Federation intended for export outside of the EAEU and not intended for application within the EAEU;
- medical products produced in the Russian Federation for engineering and research work (tests);
- medical products in the form of packages, sets, kits and medicine boxes consisting of registered medical products and/or medicines in common packaging provided that the secondary packaging or the primary packaging (if the secondary, or consumer, packaging is not provided) of a medicine, as well as the producer (manufacturer) and the label are intact.
The Law unifies and introduces an individual regulation for the specified unregistered medical products. Such regulation will be determined by regulations of the Government of the Russian Federation and the authorised federal executive authority (the Ministry of Healthcare of the Russian Federation).
 | It appears that the new developments, on the one hand, simplify the circulation of medical products that are not subject to registration, and, on the other hand, may complicate it, specifically when the above special subordinate legislation is missing. |
Amendments to the licensing of activities relating to the production and maintenance of medical products
Starting from 1 January 2022, the licensing of activity relating to the production of medical devices will be abolished, and at the same time, with a view to producing medical products subject to the state registration and individual types of medical products made pursuant to patients’ individual orders, the inspection of production will be introduced to ensure that medical products are manufactured in accordance with the requirements for introducing, maintaining and assessing the quality management system for medical products depending on the potential risk inherent in the application of such products. The Russian Government will determine the procedure for organising and conducting inspection as well as the methods of calculating the inspection fee.At the same time, the licensing regime for activity relating to the technical maintenance of medical products will be retained: starting from 1 January 2022 the holders of licences for the production and technical maintenance of medical devices will be obliged to have such licences reissued with respect to technical maintenance before 1 January 2024 as licences for activity relating to the technical maintenance of medical devices. In the event that a licence is reissued, the licensee will not be checked for compliance with the licensing requirements if the licensee does not amend the list of work performed or services provided.
The safety monitoring for medical products and state control
The amendments bring the provisions of Law No. 323-FZ into line with the requirements of the EAEU’s regulations, which includes introducing the term “unfavourable developments”. This means the side effects that are not specified in the patient information leaflet as well as undesirable reactions that threaten the life and health of citizens and medical professionals applying and using the medical products.What to think about and what to do
The following subordinate legislation is expected to be adopted in pursuance of the law’s provisions:- The Russian Government’s Resolution on adopting the procedure for organising and conducting an inspection of the production of medical products for compliance with the requirements for implementing, maintaining and assessing the quality management system for medical products depending on the potential risk inherent in their application;
- The Russian Government’s Resolution on adopting the procedure for importing into the Russian Federation medical products that are not subject to state registration;
- The Russian Government’s Resolution on the procedure for granting, reissuing, confirming and withdrawing a licence for the application of an unregistered medical product for in vitro diagnostics, etc.
Moreover, on 1 January 2021, Resolution No. 1445[3] of the Russian Government dated 15 September 2020 came into force establishing a requirement to have all of the licences that have been issued before 1 January 2021 reissued before 31 December 2023. This Resolution also enacts that one of the documents that an applicant needs to provide when obtaining a licence is a certificate of conformity to the requirements of inter-state standard GOST ISO 13485-2017.
We believe that based on the current version of the amendments, starting from 1 January 2022 Resolution No. 1445 should not apply to the licensing of activity relating to the production of medical products. Therefore, the following questions now already arise: (1) how and according to what procedure will an inspection be carried out with respect to companies which by that time will have had a licence reissued in accordance with the new requirements of the Russian Government’s Resolution No. 1445 and will have the required certificate of conformity; (2) does it make sense for companies that have not yet had a licence reissued to have a licence reissued that was obtained before 1 January 2021; (3) according to what procedure will sites on which various medical products are manufactured be inspected for the potential risk inherent in their application.
Help from your adviser
Pepeliaev Group’s lawyers are ready to provide comprehensive legal support on issues relating to the circulation of medical products. This includes providing recommendations with regard to the application procedure for the new requirements of Law No. 323-FZ, assessing the need and procedure for having licences reissued that were granted earlier, and advising on the procedure for carrying out an inspection of a production site.[1] Federal Law No. 128-FZ “On amending the Federal Law “On the fundamentals of health protection in the Russian Federation” and articles 12 and 22 of the Federal Law “On licensing individual types of activity” dated 30 April 2021 (the “Law”).
[2] Federal Law No. 323-FZ “On the fundamentals of health protection in the Russian Federation” dated 21 November 2011 (“Law No. 323-FZ”).
[3] Resolution No. 1445 of the Russian Government dated 15 September 2020 “On approving the Provisions on licensing the activities relating to production and technical maintenance of medical equipment (except for cases when the maintenance is performed for the own needs of the legal entity or individual entrepreneur)”.
[2] Federal Law No. 323-FZ “On the fundamentals of health protection in the Russian Federation” dated 21 November 2011 (“Law No. 323-FZ”).
[3] Resolution No. 1445 of the Russian Government dated 15 September 2020 “On approving the Provisions on licensing the activities relating to production and technical maintenance of medical equipment (except for cases when the maintenance is performed for the own needs of the legal entity or individual entrepreneur)”.