Article 12. State registration of medicines, medical products, and medical equipment

As a general rule, the use of medicines, medical products, and medical equipment in medical practice shall be permitted after their state registration.

The following shall be subject to state registration:

medicines (except medicinal substances (substances) used in the manufacture of medicines);

new combinations of medicines registered in the Republic of Uzbekistan;

medicines previously registered in the Republic of Uzbekistan but manufactured in different dosage forms, doses, or by another manufacturer;

medical products;

medical equipment.

State registration of medicines, medical products, and medical equipment shall be carried out by the Ministry of Health of the Republic of Uzbekistan.

Registered medicines, medical products, and medical equipment shall be included in the state register of medicines, medical products, and medical equipment permitted for use in medical practice.

It shall not be permitted to state-register, under the same trade name, medicines with different medicinal substances in their composition. Registration of medicines of the same composition of medicinal substances by one manufacturer under different trade names shall be permitted in the manner established by legislation.

Medicines and medical products prepared in pharmacies shall not be subject to state registration. When a medicine containing new chemical substances is registered, confidential information contained in the registration dossier of the medicine provided shall not be disclosed without the consent of the applicant and shall not be used for commercial purposes for six years from the date of its state registration.

“New chemical substance” means any chemical compound not previously registered within the territory of the Republic of Uzbekistan, regardless of its patentability.

Disclosure and use of the information specified in part seven of this Article without the consent of the applicant shall be permitted on the basis of a court decision if one of the following circumstances exists:

within twelve months from the date of its state registration in the Republic of Uzbekistan, the supply volume of the medicine is insufficient to meet the needs of the population;