New Rules for the destruction of seized counterfeit medicines, substandard and counterfeit medicines (hereinafter – Rules for the destruction of medicinal products) were approved by the Decree of the Government of Russia dated September 15, 2020 No. 1447.
The Rules for the destruction of medicinal products will come into force on January 1, 2021 and will remain in effect until January 1, 2027.
Counterfeit and (or) substandard medicines are subject to seizure and destruction by a decision:
Counterfeit medicinal products are subject to seizure and destruction only on the basis of a court decision.
In case of revealing the facts of import into the territory of Russia or the facts of circulation on the Russian territory of counterfeit and (or) substandard medicinal products, the Federal Service for Surveillance in Healthcare or the Federal Service for Veterinary and Phytosanitary Surveillance take a decision obliging the owner of these medicinal products to seize and destroy or export them in full from the territory of Russia.
When the authorized body makes a decision on the seizure and destruction of counterfeit medicines and (or) low-quality medicines, the owner of such medicines is obliged to:
- withdraw such medicinal products from circulation, isolate and place them in a specially allocated room (zone) or report disagreement with the specified decision to the authorized body within 30 days from the date of the decision;
- destroy medicinal products medicines within 6 months from the date of the decision.
If the owner of counterfeit and (or) substandard medicinal products does not agree with the decision to seize and destroy these medicinal products, as well as if he did not comply with this decision and did not inform about the measures taken, the authorized body applies to the court for appeal.
Counterfeit and substandard medicines placed under the customs procedure for destruction are subject to destruction in accordance with the EAEU law and the Russian legislation on customs regulation.
It is important that the destruction of falsified, substandard and counterfeit medicinal products is carried out by an organization licensed to carry out activities for the collection, transportation, processing, disposal of wastes of I – IV hazard classes.
The owner of low-quality medicinal products, who made a decision to seize, destroy or export them alternatively:
- destroys medicinal products;
- transfers them to the organization that destroys the medicinal products, on the basis of an agreement;
- carries out their full export from the territory of Russia.
The owner of counterfeit medicines, who made a decision to seize, destroy or export them:
- transfers the said medicines to the organization that destroys drugs on the basis of an agreement;
- carries out their export in full.
The costs associated with the transportation and destruction of falsified, substandard and counterfeit medicines are reimbursed by their owner.
The owner of low-quality medicinal products or the organization that destroys medicinal products draws up an act of destruction:
- date and place of destruction of medicines;
- full name of the person (s) who took part in the destruction, place of work and position;
- justification for destruction;
- information about destroyed medicines;
- manufacturer's name;
- information about the owner;
- method of destruction.
The act on the destruction of medicines is drawn up on the day of destruction with the provision of a copy to the authorized body using electronic means of communication.
October 7, 2020
Lawyers of the practice “Healthcare and Pharmaceuticals” of
BRACE Law Firm ©