Decree of the Government of the Russian Federation of June 29, 2021 No. 1049 “On federal state control (supervision) of medicinal products circulation” approved a new Regulation on federal state control (supervision) in the field of drug circulation (hereinafter referred to as the “Regulation”). The Regulation entered into force on 01.07.2021. At the same time, the Decree of the Government of the Russian Federation of October 15, 2012 No. 1043 “On Approval of the Regulation on Federal State Supervision in the Sphere of Medicines Circulation” and a number of other Government acts were declared invalid.
The Regulation establishes that the subjects of federal state control (supervision) in the field of drug circulation are:
- compliance with mandatory requirements in the field of drug circulation, including requirements for preclinical and clinical trials of drugs, compliance of drugs in circulation with indicators of quality, efficacy and safety;
- observance by controlled persons of the restrictions established by Articles 67.1 and 67.2 of the Federal Law “On the Circulation of Medicinal Products” (restrictions in the implementation of activities in the field of circulation of medicines, requirements for scientific events for medical workers);
- compliance with licensing requirements for the implementation of pharmaceutical activities;
- compliance of controlled persons with the requirements for the provision of information on medicines and (or) medicines.
This Regulation contains a chapter on risk management by categories, dividing them into the following:
- significant risk;
- medium risk;
- moderate risk;
- low risk.
The assignment of objects of state control to a certain category of risk is carried out on the basis of the criteria for assigning objects of state control (supervision) in the field of medicinal products circulation. The annexes to the document provide such criteria as the conditions for carrying out activities for the production of medicines, their storage, transportation, etc.
Depending on the risk criterion, the frequency of certain control (supervisory) measures is established:
- for the category of significant risk: an inspection visit once every 3 years; on-site inspection - once every 3 years; documentary check once every 3 years;
- for the medium risk category, one of the specified control (supervisory) activities: inspection visit once every 5 years; on-site inspection once every 5 years; documentary verification once every 5 years;
- for the category of moderate risk, one of the specified control (supervisory) activities: inspection visit once every 6 years; on-site inspection once every 6 years; documentary verification once every 6 years.
- in respect of objects of state control classified as low risk, scheduled inspections are not carried out.
The possibility of prevention of violations with the following preventive measures:
- generalization of law enforcement practice;
- announcement of a warning;
- preventive visit.
If there is information about impending violations, it is possible to announce a warning about the inadmissibility of violating the mandatory requirements with a proposal to take measures to ensure compliance with the mandatory requirements. The controlled person has the right, within 15 calendar days from the date of receipt of the warning, to file an objection to the said warning.
It is established that for the fixation of evidence of violations of mandatory requirements by officials authorized to conduct federal state control (supervision) in the sphere of circulation of medicines, and by persons involved in the performance of control (supervisory) actions, photography, audio and video recording can be used in the event of: test purchase; on-site inspection; conducting an inspection visit.
Also, this document introduced supervision over compliance with mandatory requirements (safety monitoring) (pharmacovigilance), which is carried out in order to identify side effects, adverse reactions, serious adverse reactions, unforeseen adverse reactions when using medicinal products, individual intolerance, lack of effectiveness of medicinal products, as well as other facts and circumstances that pose a threat to the life or health of humans and animals when using medicinal products identified at all stages of the circulation of medicinal products in the Russian Federation and other states.
In addition, Federal Service for Surveillance in Healthcare annually approves a program for the prevention of risks of harm to legally protected values, which is posted on its official website.
These innovations actually change the focus of inspections, paying great attention to preventive measures and the introduction of a risk-based approach, which, in our opinion, increases the likelihood of reducing possible violations.
July 11, 2021