Uzbekistan recognized the results of registration of medicines from 20 countries

The adoption of this decision will have a positive impact on the prices of medicines, the cost of medicines and medical supplies will not include the costs of certification of medicines, - commented Aziz Abdukhakimov.

According to the Decree of the President of the Republic of Uzbekistan “On additional measures to improve the procedure for state registration and circulation of medicines”, this list includes:

1. Commonwealth of Australia

2. Kingdom of Belgium

3. United Kingdom of Great Britain and Northern Ireland

4. Federal Republic of Germany

5. Kingdom of Denmark

6. State of Israel

7. Republic of Ireland

8. Kingdom of Spain

9. Italian Republic

10 Canada

11. Republic of Korea

12. Kingdom of the Netherlands

13. Kingdom of Norway

14. Republic of Slovenia

15. United States of America

16. Republic of Finland

17. French Republic

18. Swiss Confederation

19. Kingdom of Sweden

20. Japan

21. European Medicines Agency (EMA)

Recognition will be carried out 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 of the Republic of Uzbekistan (hereinafter referred to as the State Center). The decision will be made based on the results of studying the documents for medicines submitted for recognition.

Recognition provides for the inclusion of the results of state registration and a record of recognition in the State Register and the issuance to applicants, at their request, of an extract from this register. The results of recognition are included in the form of an entry in the State Register for a period of five years. After the expiration of the first recognition, at the request of the applicant, the results of recognition can be included in the State Register without limitation of their validity.

The following are subject to recognition:

• medicines;

• new combinations of medicines registered in the Republic of Uzbekistan;

• medicines previously registered (recognised) in the Republic of Uzbekistan, but produced in other dosage forms, dosages or by another manufacturer;

• medicines previously registered (recognized) in the Republic of Uzbekistan in a different package and / or with a different label.

For the recognition of medicines, the applicant submits to the State Center an application in the established form with the attachment:

a) instructions for medical use, an authorized translation of instructions into the state language and Russian;

b) documentation of the medicinal product, which indicates:

• dosage form;

• dosage;

• the date before which the medicinal product is authorized

• for use in medical practice in the country specified in the List,

• or quality, safety and effectiveness of which is confirmed by an international organization specified in the List;

• unique number (authorization) of drug product approval for the relevant market;

c) the original of the marking sample in paper or electronic form;

d) reference standard of medicinal substances, foreign impurities, with documents confirming their quality;

e) a sample of the medicinal product - sufficient to carry out three-time tests in accordance with the requirements of the regulatory document of the manufacturer, accompanied by a certificate of analysis of the medicinal product;

f) certificate of pharmaceutical product (CPP) issued by a foreign authorized body regulating foreign or interstate pharmaceutical products, or a duly certified copy. At the same time, a document equivalent to a pharmaceutical product certificate (CPP) or a duly certified copy thereof can be submitted;

g) specifications of the manufacturer for the medicinal product (pharmacopoeia monograph).

If the document provided for in one of the subparagraphs of this paragraph also includes other information specified in another subparagraph of this paragraph, its submission as a separate document is not required.

For the recognition of medicinal substances (substances) registered outside the Republic of Uzbekistan and inclusion of an entry about this in the State Register, the applicant submits to the State Center an application in the form in accordance with Appendix No. 2 to this Regulation, with the attachment:

a) copies of the GMP certificate;

b) normative document of the substance;

c) color marking layout;

d) reference standard of medicinal substances (substances), foreign impurities, with documents confirming their quality;

e) a sample of the medicinal substance (substance) - in an amount sufficient to conduct three tests in accordance with the requirements of the regulatory document of the manufacturer, with a certificate of analysis of the medicinal substance (substance) attached.

Also, from November 1, the requirement to issue a registration certificate (its duplicate) of a medicinal product is canceled by issuing, at the request of the applicant, an extract from the State Register of Medicines, Medical Devices and Medical Equipment.