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" with last amendments dated January 04, 2016 active pharmaceutical substances (APIs) are allowed for manufacturing of medicinal products in Uzbekistan only after state registration.

It is possible to register an active pharmaceutical substance together with the medicinal product that contains said active pharmaceutical substance or in a separate registration.

In order to register the pharmaceutical substance it is necessary to provide the following documents to the Main Directorate for Quality Control of Medicinal Products 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 extract from the register of legal entities for 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;
  • certificates of analysis for 3 production batches from API manufacturer.

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

3) Samples of pharmaceutical substance in an amount required for the triple test.

According to the Uzbek legislation the procedure of state registration of pharmaceutical substance should be conducted within 180 workdays 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 6-8 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 6-8 months.

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

17 a-uy, Osiyo Ko'chasi Str.

Mirzo-Ulugbekskiy District

Tashkent, 100000

Uzbekistan

Email: office@msp.uz