Russian Government adopted a number of legislative acts supplementing licensing requirements to subjects of circulation of medical drugs on May 15, 2020.
2. Who is affected?
The novelties affect holders of licenses for medical products’ manufacture, pharmaceutical and medical activity.
3. What are the amendments?
The list of licensing requirements to medical products’ manufacturers includes registration in drug circulation monitoring system (hereinafter – “DCM system”) and application of identification means on packaging for medial drugs, other subjects of circulation are obliged to include information on circulation of medical drugs in the DCM system (under para. 7 art. 67 of the Federal law “On circulation of medical products”).
4. What are the consequences?
In case legal entities fail to meet the above requirements, they will bear liability under para. 3 art. 14.1 of the Code of administrative offences and will be exposed to a fine in the amount of 100 to 200 thousand rubles or administrative suspension of activity will be imposed.
Russian Government adopted a number of legislative acts on May 15, 2020 in the area of circulation of medical drugs:
Government Regulation № 686 “On the introduction of amendments to the Regulation on licensing manufacture of medical products”;
Government Regulation № 687 “On the introduction of amendments to para. 5 of the Regulation on licensing of pharmaceutical activity”;
Government Regulation № 688 “On the introduction of amendments to para. 5 of the Regulation on licensing of medical activity (with the exception of the above activity carried out by medical organizations and other organizations within private healthcare system on the territory of Skolkovo innovation center)”.
The above Regulations are relevant for:
– medical products’ manufacturers;
– persons carrying out wholesale and retail trade of medical products;
– organizations carrying out medical activity.
Regulation № 686 provides for the following requirements for manufacturers of medical products:
– registration of a license holder in the DCM system;
– inclusion of information on medical drugs in the DCM system;
– application of identification means on primary and secondary packaging of medical products.
Registration in the DCM system by the subjects of circulation of medical products is necessary for fulfilling the requirements on the introduction of information on medical products to the DCM system under section VI of the Government Regulation № 1556 dated December 14, 2018 “On approval of Regulation on medical drugs circulation monitoring system”. Medical drugs produced before July 1, 2020 are subject to storage, transportation, dispensation, realization, transfer, use without application of identification means up to the date of expiry under para. 7.1 art. 67 of the Federal law “On circulation of medical products”. Meanwhile provision of information on marked medical products to the DCM system will be obligatory for all subjects of circulation of medical products under para. 1.1 of the Government regulation № 1556 starting from June 1, 2020.
Regulation 687 affects wholesale and retail traders of medical products, whereas Regulation 688 covers organizations carrying out medical activity. Regulations 687 and 688 supplement the list of licensing requirements with the obligation to include information on medical drugs in the DCM system under para. 7 art. 67 of the Federal law “On circulation of medical products”.
Therefore, the key differences between the new Government Regulations would be their targets of regulation, i.e. Regulation 686 affects medical drugs’ manufacturers, meanwhile Regulations 687 and 688 – traders of medical drugs and organizations carrying out medical activity, respectively.
Currently art. 6.34 of the Code of Administrative offences of the Russian Federation provides for a liability (fine) for untimely introduction of information to the DCM system or introduction of false information in the amount of:
– 5 to 10 thousand rubles for officials;
– 50 to 100 thousand rubles for legal entities.
Upon the enforcement of the above Government Regulations requirements for registration, for inclusion of information to the DCM system and identification means application will become licensing requirements. Therefore, violation of such requirements shall be qualified as performing entrepreneurial activities with gross violation of licensing requirements with the liability in the form of fine in the amount of:
– 4 to 8 thousand rubles for sole proprietors or administrative suspension of activity for a term of up to 90 days;
– 5 to 10 thousand rubles for officials;
– 100 to 200 thousand rubles for legal entities or administrative suspension of activity for a term of up to 90 days.
The amendments stipulated by Regulations 686, 687, 688 enter into force on July 15, 2020 simultaneously with the obligation on mandatory application of identification means on medical drugs (para.7.1 art. 67 of the Federal law “On circulation of medical products”). The transformation of the requirements provided in current legislation (art. 67 of the Federal law “On circulation of medical products”) into licensing requirements for subjects of circulation of medical drugs shall contribute to better fulfillment of such requirements. As the Federal Service for Surveillance in Healthcare states, the requirements for medical organizations to include information in the DCM system will allow for an open medication help system for citizens [1].
[1] Information by “The inclusion of information on medical products in the federal state information system for monitoring of medical drug will become a mandatory licensing requirement since July 1, 2020.
Ksenia Stepanishcheva, counsel
Ekaterina Pochtareva, assistant attorney