Mikhailyuk, Sorokolat & Partners

Patent and Trademark Attorneys
Registration of medicinal products in Uzbekistan

STATE REGISTRATION OF MEDICINAL PRODUCTS IN UZBEKISTAN

Issues associated with the state registration of medicinal products in Uzbekistan are regulated by the Ministry of Health of the Republic of Uzbekistan. In accordance with the law of the Republic of Uzbekistan "On medicinal products and pharmaceutical activity", medicinal products are allowed for use in Uzbekistan only after state registration thereof.


Possible ways of registration of medicinal products

The Uzbek legislation stipulates two possible ways of the state registration of a medicinal product:

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

What is required for state registration

In order to register a medicinal product according to the Decree of the Cabinet of Ministers of the Republic of Uzbekistan No. 213 of March 23, 2018, it is necessary to provide the following to the State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment under the Ministry of Health of the Republic of Uzbekistan:

1) Application 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 Manufacturer's Authorizations for all manufacturing sites involved in the manufacturing process issued by competent authorities of countries-manufacturers;
  • legalized copies of GMP Certificates for all manufacturing sites involved in the manufacturing process issued by competent authorities of countries-manufacturers;
  • legalized copy of an agreement or a letter on relationships between the applicant and manufacturer of the medicinal product, if different;
  • legalized copy of certificate of a pharmaceutical product (CPP) or legalized 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 competent authorities of countries, where said medicinal product is registered, or justification of their absence.

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

3) Samples of the medicinal product and standard samples in an amount required for the triple test.

Please note that in case of registration of an original (new) medicinal product, it is necessary to provide a full registration dossier including the data on preclinical and clinical studies and examination thereof.


WHAT IS REQUIRED FOR RECOGNITION OF THE STATE REGISTRATION

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

1) Application with the attached documents:

  • legalized Power of Attorney from the applicant to the representative;
  • legalized copy of registration certificate issued by a competent authority of country, wherein regulatory authorities apply high quality standards;
  • legalized copy of an instruction for medical use approved in a country, wherein regulatory authorities apply high quality standards, together with its certified translation to Uzbek and Russian;
  • legalized copy of certificate of a pharmaceutical product (CPP) or Free Sale Certificate;
  • proposed mockups for the Uzbek market;
  • specification(-s) and methods of control of the finished medicinal product.

2) Samples of the medicinal product and standard samples of 1 batch in an amount required for the triple test.


Duration of registration process

According to the Uzbek legislation the procedure of state registration of a medicinal product should be conducted within 155 days without consideration of the time for preparation of responses to requests. However, in accordance with the usual practice depending on 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 a medicinal product in Uzbekistan may constitute about 6-8 months without consideration of the time for preparation of responses to requests.

The procedure of recognition of the state registration of a medicinal product should be conducted within 2 months after receipt of payment by the State Center of Expertise and Standardization of Medicines, Medical Devices and Medical Equipment under the Ministry of Health of the Republic of Uzbekistan.


Validity term and renewal

The Certificate about the state registration of a medicinal product in Uzbekistan is valid for 5 years and after that it is necessary to renew it each 5 years. The procedure of renewal of the registration must be initiated within 3 months before expiration of previous registration. The renewal procedure does not require checking the pre-clinical and clinical data. The usual renewal procedure lasts for about 5-7 months without consideration of the time for preparation of responses to requests.

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

For more detailed information, including on the costs associated with registration of medicinal products in Uzbekistan, list of documents required for submission, sample of the Power of Attorney for execution, etc. contact our specialists.


Read also:


Tashkent

8 g, Bunyodkor Ave.
Shaykhontohur District
Tashkent, 100027
Uzbekistan

Email: office@msp.uz