The procedure of simplified import of imported medicines has been approved
26.12.2018
The procedure of simplified import of imported medicines has been approved
Earlier it was reported that a list of countries and international organizations was approved, the results of registration of medicines of which will be recognized in the Republic of Uzbekistan from November 1, 2018. On October 24, the Cabinet of Ministers approved the procedure according to which this norm will be implemented.
Recall, according to the Decree of the President of the Republic of Uzbekistan "on additional measures to improve the order of state registration and turnover of medicines" in the list of countries and international organizations, the results of registration of medicines which from November 1, 2018 will be recognized in the Republic of Uzbekistan:
1. commonwealth
2. Kingdom of Belgium
3. United Kingdom of great Britain and Northern Ireland
4. 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 Netherlands
13. Kingdom of Norway
14. Republic of Slovenia
15. United States of America
16. finnish republic
17. republic of france
18. Swiss Confederation
19. Kingdom of Sweden
20. Japan
21. European medicines Agency (EMA)
In accordance with the resolution of the Cabinet of Ministers "on approval of the regulations on the procedure for recognition of the results of registration of medicines carried out outside the Republic of Uzbekistan" recognition is carried out by The state center for examination and standardization of medicines, medical products and medical equipment Of the Agency for the development of the pharmaceutical industry under the Ministry of health of the Republic of Uzbekistan by studying the documents provided and inclusion of the record of recognition in the State register of medicines, medical devices and medical equipment authorized for use in medical practice.
Recognition provides for the inclusion of the results of state registration and record of recognition in The state register and the issuance of an extract from the register to the applicants at their request.
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.
Subject to recognition:
medicines;
new combinations of medicines registered in the Republic of Uzbekistan;
medicines previously registered (recognized) in the Republic of Uzbekistan, but produced in other dosage forms or by other manufacturer;
medicines previously registered (recognized) in the Republic of Uzbekistan in other packaging and/or with other markings.
The record of recognition in the state register confirms the fact of state registration and permission of the Ministry of health of the Republic of Uzbekistan to use the drug in medical practice.
It is not allowed to recognize medicines with different medicinal substances under the same trade name, as well as one manufacturer having the same composition of medicinal substances – under different trade names.
Termination of recognition and exclusion of this record from The state register shall be made by The state center in the following cases:
the establishment of a ban on the use of the drug in the Republic of Uzbekistan and the countries listed in the List;
detection in the application of the drug serious side effects not specified in the instructions for medical use;
identification of serious consequences for the health of citizens when using the drug;
at the initiative of the applicant.
Annulment of recognition and exclusion of this record from the State register shall be carried out in the court in case of establishing the fact of recognition and making a record of it in the state register with the use of false documents.
For recognition of medicines the applicant provides to The state center the statement of the established form with Appendix:
a) instructions for medical use, authorized translation of instructions into the state language and Russian;
b) documentation of the medicinal product, which contains:
dosage form;
dosage;
date before the expiry of which the medicine is authorized for use in medical practice in the country specified in the List, or the quality, safety and effectiveness of which is confirmed by the international organization specified in the List;
a unique number (authorization) admission of a medicinal product on the market;
C) the original of the marking sample in paper or electronic form;
d) reference standard of medicinal substances, foreign impurities with the application of documents confirming their quality;
e) a sample of the medicinal product-sufficient for carrying out three-time tests in accordance with the requirements of the regulatory document of the manufacturer with the application of the certificate of analysis of the medicinal product;
f) a certificate of a pharmaceutical product (SRR) issued by a foreign authorized body regulating foreign or interstate pharmaceutical products, or a copy certified in accordance with the established procedure. At the same time, a document equivalent to the certificate of a pharmaceutical product (SR) or a copy thereof certified in accordance with the established procedure may be submitted;
g) draft regulatory document of the medicinal product.
If the document provided in one of subparagraphs of this point includes also other information specified in other subparagraph of this point, its representation in the form of the separate document is not required.
For the recognition of medicinal substances (substances) registered outside the Republic of Uzbekistan, and the inclusion of an entry about it in the state register, the applicant shall submit to The state center an application in the prescribed form with the application:
(a) copies of the certificate of good manufacturing practice (GMR);
b) draft regulatory document of the medicinal substance (substance);
C) color layout marking;
d) reference standard of medicinal substances (substances), foreign impurities with the application of documents confirming their quality;
e) a sample of a medicinal substance (substance) - in an amount sufficient to conduct three-time tests in accordance with the requirements of the regulatory document of the pharmaceutical manufacturer with the application of the certificate of analysis of the medicinal substance (substance).
The application with the necessary documents shall be submitted to The state center directly, through the means of postal communication or in electronic form with notification of its receipt. The application submitted in electronic form is confirmed by the electronic digital signature of the applicant.
Samples of medicines shall be submitted directly or through postal communication.
Oleg Gaevoy
