On January 30, 2024, the President of Russia signed Federal Law No. 1-FZ, which introduced substantial amendments to Federal Law No. 61-FZ dated April 12, 2010 ("Law on Circulation of Medicines").
The legislative novelties are primarily aimed at harmonizing national regulation and rules established in the EAEU unified market.
Article 3 of the Law on Circulation of Medicines is supplemented with a direct indication that the EAEU acts are an integral part of the Russian regulation in the area of circulation of medicines, and the priority of the EAEU rules over the provisions of the Law on Circulation of Medicines is enshrined.
At the same time, Article 1 distinguishes between "state registration" - a procedure carried out in accordance with the Law on Circulation of Medicines, and "registration", which is carried out in accordance with international treaties and EAEU acts.
Changes in the legislative terms:
- The definition of an orphan pharmaceutical has been adjusted in accordance with the definition set out in the EAEU Rules;
- The concept of a high-tech pharmaceutical was introduced – it is a genotherapeutic pharmaceutical for medical use, or a pharmaceutical based on somatic cells for medical use, or a tissue engineering product;
- The definition of the “general pharmacopoeial article” is supplemented with the indication of auxiliary substances, and “pharmacopoeial article” - with medicinal plant raw materials and auxiliary substances;
- The definition of a marketing authorisation for a pharmaceutical was updated and now is defined as "an entry in the State Register of Medicines confirming the fact of state registration of a pharmaceutical and (or) a document confirming the fact of state registration (registration) of a pharmaceutical";
- The definition of a patient information sheet was amended to indicate that instead of a written form, a patient's voluntary consent to participate in a clinical trial is obtained in "the form of an electronic document signed by the patient (his/her legal representative) using an enhanced qualified electronic signature or a simple electronic signature through the use of an ESIA (Gosuslugi), and at the patient's request in written form".
Changes in the circulation of orphan pharmaceuticals:
The registration process for orphan pharmaceuticals has been simplified: if a rare disease is not listed in the Federal Law No. 323-FZ dated November 21, 2011 "On the Fundamentals of Public Health Protection in the Russian Federation", the request must contain a justification as to why the disease is considered to be orphan.
It is stipulated that the possibility to consider a pharmaceutical as an orphan pharmaceutical may be determined both in respect of registered medicines (under the national procedure or EAEU legislation) and unregistered medicines, and a detailed list of documents to be submitted for expert examination is specified.
If the materials provided are insufficient, the applicant will have the opportunity to provide the missing information within 60 days of receiving the request from the examiners.
It is also expressly stipulated that within 12 months from the date of registration the import and circulation of orphan pharmaceuticals in packages intended for circulation in foreign countries is allowed.
When entering civil circulation, it is not necessary to submit a test report in respect of orphan pharmaceuticals derived from the biomaterial of a certain person and intended for use by that person.
Amendments are made to the procedure of State registration confirmation for pharmaceutical specified in Article 29 of the Law on Circulation of Medicines:
- The terms for confirmation of state registration of a pharmaceutical when issuing an indefinite marketing authorization have changed - now it is carried out within a period not exceeding 40 working days from the date of submission of an application to the authorized body via the Gosuslugi portal, instead of 60 days as it was before;
- At the same time, the possibility of providing a copy of the manufacturer's certificate of conformity with the requirements of the EAEU GMP rules as part of the package of documents for this procedure is established;
- The time limits within which the authorized body must conduct a review of the applicant's documents and make a decision to conduct or refuse to conduct an expert examination within the framework of the procedure, as well as the time limits for its decision-making on the results of the expert examination, have been reduced from 10 to 5 days;
- In case of revealing unreliable or insufficient information, the applicant shall provide the authorized body or the expert with documents (materials) in digital form via the Gosuslugi portal;
- The timeframe for the examination of the risk/benefit ratio has been reduced from 40 to 30 days.
We also highlighted the following changes:
- According to the amendments, by September 1, 2025 the process of registration of a pharmaceutical will be carried out through the use of FGIS EPGU.
- Pre-clinical trials of a medicine for medical use are conducted in accordance with the rules of the EAEU. Previously, the law provided that preclinical trials were conducted under rules approved by an authorized federal body.
- The list of entities that can conduct preclinical research has been expanded to include "other organizations" with appropriate material and technical capabilities and qualifications.
- Reduction the period for State registration of a medicinal product for veterinary use from 160 to 120 working days.
Introduction of electronic document workflow:
The majority of procedures related to the registration and circulation of medicines are being transferred to electronic form through the use of FGIS “Gosuslugi” and EGISZ.
Namely, interaction in the electronic format is carried out in connection with:
- expert examination of medicines;
- confirmation of state registration of a pharmaceutical;
- amendments to the documents contained in the registration dossier;
- clinical trials of a pharmaceutical;
- putting medicines into civil circulation;
- registration (re-registration) of the maximum selling price of a pharmaceutical.
The amendments will come into effect from 1 January 2025.
The amendments concern the procedure for putting medicines into civil circulation:
The rules on the obligation to provide the authorised body with documents confirming quality and compliance with the requirements established during registration (state registration) when putting each series (batch) into civil circulation now also apply to pharmaceutical substances.
It is specified that the requirement to provide the authorised body with a testing protocol is established irrespective of the dosage of a medicinal product under one Marketing Authorisation in relation to the first three series (batches) of a pharmaceutical manufactured or imported for the first time.
In case of:
- provision of information about the date of issue and registration number of the report (certificate) on compliance with GMP rules for the production site involved in the production of finished dosage form and issuing quality control, and
- absence within 3 years prior to the date of issuance of the test report of cases of detection of non-compliance of medicines with quality requirements at all production sites involved in the production of a pharmaceutical,
it is allowed to submit a test report only in respect of the first series (batch) of a pharmaceutical manufactured/imported for the first time.
For orphan drugs, the requirement to submit a test report for the first 3 series (batches) does not apply.
Also changes to the procedures include:
- the possibility of conducting tests for the preparation of the protocol by way of remote interaction;
- shifting the deadline for annual submission of the trial protocol from 1 February to 1 April. For orphan drugs it is allowed once every three years.
Cancellation of state registration of pharmaceuticals:
The rule on cancellation of state registration of a pharmaceutical and its exclusion from state register (GRLS) in case it has been out of civil circulation in the Russian Federation for 3 or more years will not apply to pharmaceuticals for medical use from 1 January 2026.