Decree of the Government of Russia dated October 1, 2020 No. 1583 approved the Rules for the circulation of generic drugs and biosimilars until the end of the period established for conducting studies of their bioequivalence or therapeutic equivalence (hereinafter – the Rules), which entered into force on October 5, 2020.
The Rules establish the procedure for handling before the end of the study period for their bioequivalence or therapeutic equivalence in relation to the reference drug or to bring the indications for use and contraindications for use in the instructions of such drugs in accordance with the instructions.
It is important to pay attention to the fact that during this period the following measures of quality control and safety of medicinal products are established:
- selective quality control;
- submission by the holder or owner of the marketing authorization to Federal Service for Surveillance in Healthcare (Roszdravnadzor) of periodic reports on the safety of medicinal products once every 3 months, starting from the day the requests are sent.
The procedure for establishing interchangeability and making changes to the documents of the registration dossier includes the following steps:
1. The Ministry of Health of Russia, within 3 working days from the date of receipt from The Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of Russia of information about the absence in the registration dossier for a generic drug, the interchangeability of which has not been established, as well as in the registration dossier for a biosimilar (biosimilar) drug the results of a bioequivalence or therapeutic equivalence study with respect to the reference drug sends a request to the holder or holder of the marketing authorization of the reproduced drug, biosimilar drug to submit a report on the results of clinical trials.
2. An application for a permit to conduct a clinical trial must be submitted to this request within 180 working days. At the same time, a report on the results of a clinical study of a reproduced drug, biosimilar drug is submitted within a period not exceeding 3 months from the date of its completion.
3. Further, the Ministry of Health of Russia, within 10 working days, sends a report to the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of Russia to give an opinion on the interchangeability of medicinal products or that the medicinal product is not interchangeable.
4. Within 3 working days from the date of receipt of information on the presence of differences in indications for use and contraindications for use in the instructions for medical use of interchangeable medicinal products, sends to the holder or owner of the registration certificate of the reproduced medicinal product, biosimilar medicinal product (authorized by him to another legal entity) a request for the need to bring indications for use and contraindications for use in the instructions for medical use of such a drug in accordance with the instructions with the establishment of a period of not more than 6 months.
5. The holder or owner of the registration certificate shall, within 30 working days from the date of receipt of the request, send an application for amendments to the documents contained in the registration dossier for the registered medicinal product.
6. The Ministry of Health of Russia, within 10 working days from the date of submission to the documents contained in the registration dossier, sends information to the expert institution to give an opinion on the interchangeability of medicinal products or that the medicinal product is not interchangeable, taking into account the updated instructions for medical use of a generic drug, biosimilar drug.
October 7, 2020
Lawyers of the practice “Healthcare and Pharmaceuticals”
BRACE Law Firm ©