Resolution of the Cabinet of Ministers No. 213 of 23.03.2018 approved the Regulation on the procedure for state registration of medicines, medical devices and medical equipment and the issuance of a registration certificate.

The previous version of the document is no longer valid. Let's look at the main changes introduced by the new act.

First, earlier registration of medicines, medical devices and medical equipment was carried out by the Main Department for Quality Control of Medicines and Medical Equipment of the Ministry of Health. Now this function is performed by the State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment of the Agency for the Development of the Pharmaceutical Industry under the Ministry of Health.

Secondly, it is established what exactly is subject to registration. This:

• medicinal products;
• new combinations of medicines registered in Uzbekistan;
• medicinal products previously registered in Uzbekistan, but produced in other dosage forms, dosage forms or by another manufacturer;
• medical products;
• medical equipment.

Important! Medicines and medical products manufactured in pharmacies, as well as imported for scientific research, conducting preclinical and clinical studies, state registration procedures, and exhibiting at exhibitions, fairs, and international forums are not subject to registration.

Third, the package of documents required for registration and obtaining a certificate has changed. Now this requires::

• application in accordance with the established form;
• registration documents of a medicinal product or medical device and medical equipment in 2 identical copies, certified by the signature and seal of the applicant;
• samples of the medicinal product in the amount required for conducting 3-fold tests in one industrial batch;
• samples of medical products or medical equipment in the amount required for testing;
• standard samples of active substances, medicinal substances( substances), foreign impurities and related substances, control materials, specific reagents and documents confirming their quality.

You no longer need to submit a copy of the certificate of state registration of a business entity.

Fourth, the time frame for reviewing an application for issuing a certificate has been reduced. Previously , the deadline was the same-180 days from the date of accepting the application. Currently, it varies by registered objects and amounts to:

50 days – for medicinal substances;

120 days – for medicinal products in the form of pre-packaged and packaged pharmacopoeial medicinal plant raw materials, dressings, products for punctures, injections, transfusions and suction, contraceptives, rubber, rubber-latex, latex, polymer products for medical purposes, products for first aid, patient care items;

155 days – for other medicines, medical devices and medical equipment.

For your reference: the validity period of the issued ID has not changed. As before, it is 5 years old. The amount of the fee for reviewing the application and issuing a certificate remained the same – 10 and 2 minimum wages, respectively (1,722,400 and 344,480 soums as of the publication date).

The document was officially published in the National Legislation Database and entered into force on 26.03.2018.

The full text of this document, with comments and links to other legislative acts related to it, can be found in the information and search engine "Legislation of the Republic of Uzbekistan".

www.norma.uz: Lenara Khikmatova.