MIKHAILYUK SOROKOLAT & PARTNERS

Patent and Trademark Attorneys

STATE REGISTRATION OF APIs IN UZBEKISTAN

Issues associated with the state registration of active pharmaceutical ingredients are regulated by the Ministry of Health Protection of the Republic of Uzbekistan. In accordance with law of the Republic of Uzbekistan "On medicinal products and pharmaceutical activity" active pharmaceutical substances (APIs) are allowed for manufacturing of medicinal products in Uzbekistan only after state registration.According to the Uzbek legislation two ways of the state registration of an active pharmaceutical substance are stipulated, namely:

  • State registration of an active pharmaceutical substance within the frame of the procedure according to the Decree of the Cabinet of Ministers of the Republic of Uzbekistan of March 23, 2018 No. 213;
  • Recognition of the state registration within the frame of conducting the simplified procedure according to the Decree of the Cabinet of Ministers of the Republic of Uzbekistan of October 24, 2018 No. 862 (used only for medicinal products that have been registered in country , wherein regulatory authorities apply high quality standards, particularly of EU Member States, Switzerland, UK, USA, Canada, Japan, Australia, Korea).

Ⅰ. In order to register a pharmaceutical substance within the frame of the procedure according to the Decree of the Cabinet of Ministers of the Republic of Uzbekistan of March 23, 2018 No. 213 it is necessary to provide the following to the State Centre of Expertise and Standardization of Medicinal Products, Medical Devices and Medical Equipment of the Ministry of Health of the Republic of Uzbekistan:

1) Application form with the attached documents:

  • legalized Power of Attorney from the applicant to the representative;
  • legalized copy of Business license of the applicant;
  • legalized copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers;
  • legalized copies of GMP Certificates for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers;
  • legalized copy of the Agreement or the Letter of relationships between the applicant and manufacturer of API if different;
  • legalized copy of certificate of a pharmaceutical product (CPP) or copy of registration certificate issued by the competent authority of country of manufacturer or justification of its absence;
  • legalized copies of registration certificates issued by the competent authorities of countries, where the product is registered, or justification of their absence.

2) Registration dossier in the format of 4 parts (including administrative, chemical, pharmaceutical and biological documentation).

3) Samples of a pharmaceutical substance and standard samples of 1 batch in an amount required for the triple test.

According to the Uzbek legislation the procedure of state registration of a pharmaceutical substance should be conducted within 50 days without considering the time for preparation of responses to the remarks. However, in accordance with the usual practice depending upon the completion of the provided materials and scope of documentation, number of requests of the competent authority and other factors the procedure of state registration of pharmaceutical substance in Uzbekistan may constitute about 2-3 months without considering the time for preparation of responses to the remarks.

The Certificate about the state registration of a pharmaceutical substance in Uzbekistan is valid for 5 years and after that it is necessary to renew it each time for the next 5 years. The procedure of the renewal of the registration must be initiated within 3 months before expiration of previous registration. The usual renewal procedure lasts within about 2-3 months.

Ⅱ. In case of recognition of the state registration within the frame of conducting the simplified procedure according to the Decree of the Cabinet of Ministers of the Republic of Uzbekistan of October 24, 2018 No. 862 it is necessary to provide the following to the State Centre of Expertise and Standardization of Medicinal Products, Medical Devices and Medical Equipment of the Ministry of Health of the Republic of Uzbekistan:

1) Application form with the attached documents:

  • legalized Power of Attorney from the applicant to the representative;
  • legalized copies of GMP Certificates for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers;
  • proposed mockups for the Uzbek market;
  • specification (-s) and methods of control of a finished medicinal product.

2) Samples of a pharmaceutical substance and standard samples of 1 batch in an amount required for the triple test.

According to the Uzbek legislation the procedure of recognition of the state registration of a medicinal product should be conducted within 15 working days after receipt of the payment by the State Centre of Expertise and Standardization of Medicinal Products, Medical Devices and Medical Equipment of the Ministry of Health of the Republic of Uzbekistan.

The validity of the conclusion on recognition of the state registration of a pharmaceutical substance in Uzbekistan is 5 years, after that it is possible to renew it for unlimited period. The procedure of the renewal of recognition of the registration must be initiated no later than 2 months before expiration of previous conclusion.

In order we could provide you with the information on costs associated with the registration of pharmaceutical substance in Uzbekistan together with the detailed information and list of documents required from your side, sample of the Power of Attorney for execution, etc. please contact our specialists.

Tashkent

8 g, Bunyodkor Ave.

ShaykhР°ntohur District

Tashkent, 100027

Uzbekistan

Email: office@msp.uz