The Government of the Russian Federation, by Decree No. 1447 dated September 15, 2020, approved the new Rules for the Destruction of Seized Falsified, Substandard, and Counterfeit Medicines (hereinafter, the "Medicines Destruction Rules").

The Medicines Destruction Rules took effect on January 1, 2021, and shall remain in force until January 1, 2027.

Falsified and/or substandard medicines (hereinafter, "Medicines") are subject to seizure and destruction pursuant to a decision issued by:

• the owner of the medicines;
• the Federal Service for Surveillance in Healthcare (Roszdravnadzor) – with respect to medicines for human use;
• the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) – with respect to medicines for veterinary use;
• a court order.

Counterfeit Medicines are subject to seizure and destruction solely on the basis of a court order.

Upon detecting the importation into or circulation within the Russian Federation of falsified and/or substandard Medicines, Roszdravnadzor or Rosselkhoznadzor shall issue an order requiring the owner of such medicines to seize and destroy them or to completely export them from the territory of the Russian Federation.

Upon the issuance of a seizure and destruction order for falsified and/or substandard Medicines by the competent authority, the owner of such medicines shall:

• withdraw such medicines from circulation, isolate and store them in a specially designated facility (area), or notify the competent authority of its objection to the said order within 30 days from the date of its issuance;
• destroy the seized medicines within 6 months from the date the order was issued.

If the owner of the falsified and/or substandard Medicines objects to the seizure and destruction order, or if the owner fails to comply with the order and report the measures taken, the competent authority shall file a petition with the court.

Falsified and substandard medicines placed under the customs procedure for destruction shall be destroyed in compliance with Eurasian Economic Union (EAEU) law and Russian customs regulations.

Crucially, only organizations holding a license for the collection, transportation, processing, disposal, neutralization, and placement of Class I–IV hazardous waste may perform the destruction of falsified, substandard, and counterfeit Medicines.

An owner of substandard Medicines who has decided to seize, destroy, or export them shall, alternatively:

• destroy the specified Medicines;
• transfer them to a specialized drug destruction organization under a contract;
• completely export them from the territory of the Russian Federation.

An owner of falsified medicines who has decided to seize, destroy, or export them shall, alternatively:

• transfer the specified Medicines to a specialized drug destruction organization under a contract;
• completely export them.

The owner of the falsified, substandard, and counterfeit medicines shall bear all expenses associated with their transportation and destruction.

The owner of the substandard Medicines or the organization executing the destruction shall execute a destruction certificate containing:

• the date and location of the destruction of the medicines;
• the full name, place of employment, and position of the individual(s) participating in the destruction;
• the legal grounds for the destruction;
• detailed information on the destroyed medicines;
• the manufacturer's name;
• information regarding the owner;
• the method of destruction.

The relevant party shall draft the drug destruction certificate on the day of destruction and submit a copy to the competent authority via electronic communication channels.