Article 32. Cancellation of State Registration of a Medicinal Product

Decision on cancellation of state registration of a medicinal product and removal of such medicinal product from the state register of medicines shall be made by the authorized federal executive body in the following cases:

1) The relevant authorized federal executive body advances an opinion on existence of a risk or threat to the health and life of people or animals taking that medicinal product, which risk or threat exceeds the efficacy thereof based on the results of safety monitoring of the medicinal product performed by the said authorized federal executive body;
2) The developer of the medicine or any person authorized by the developer, or any other legal entity has filed an application for cancellation of the state registration of the medicinal product;
3) The state registration of the medicinal product failed to be confirmed upon expiration of the registration certificate issued for five years;
4) The applicant failed to provide information that can involve the need for amending the documents as part of the registration dossier for the registered medicinal product within 30 calendar days of the effective date of such amendments;
5) The medicinal product underwent state registration under the trade name of a medicinal product which was earlier registered under this trade name;
6) The same medicinal product was registered under different trade names by the applicant;
7) Legal judgment was passed on violation of rights of a possessor of intellectual property rights in the area of medicines.