The Unified Regulation on the Issuance of the Conclusion on the Advertising of Medicines and Biologically Active Supplements via TV and Radio channels was adopted in Uzbekistan

The Cabinet of Ministers of the Republic of Uzbekistan adopted the Resolution "On Further Improvement of the Public Services Provision System" No. 169 dated March 29, 2024 (the "Resolution No. 169").

Thus, the Resolution No. 169 approved the Unified Administrative Regulation for the provision of public services, which regulates the order of the issuance of a number of conclusions to legal entities and individuals by public authorities (the "Regulation").

Within the framework of the Regulation, the Centers of Public Services (the "CPS") and the Unified Portal of Interactive Public Services (the "UPIPS") will issue the conclusion on the possibility of advertising medicines and biologically active supplements on via TV and radio channels (the "Conclusion").

The Resolution No. 169 entered into the force on 2 April 2024. Nevertheless, public services for issuing the Conclusion should be available through the CPS or UPIPS from 1 May 2024.

Applying for the Conclusion

According to the Regulation, only legal entities may act as applicants for the Conclusion. At the same time, the Regulations do not specify which legal entities may act as applicants when applying for the Conclusion. Thus, we understand that in this case advertisers (manufacturers, distributors) or distributors of advertisement of medicines or biologically active supplements are likely to be considered as the legal entities, which may act as applicants. Also, it should be noted, that under the legislation of the Republic of Uzbekistan an advertiser and a distributor of advertisement cannot both be non-residents of the Republic of Uzbekistan

Moreover, in accordance with the Regulation, the Ministry of Health of the Republic of Uzbekistan was designated as the public authority responsible for reviewing applications and issuing the Conclusions.

According to the Regulation, in order to apply for the Conclusion, a legal entity will need to provide to provide the following information:

1. Name and legal form of the legal entity, location, telephone number of the representative (General Director, authorized representative, etc.) of the legal entity, TIN, and e-mail address (if any);
2. Content of advertisement of medicines or biologically active supplements via TV and radio channels (file (for example, brochure, presentation, etc.), audio or video material, text of advertisement);
3. The Power of Attorney on behalf of the applicant (legal entity) in the name of its representative (if applicable).

Also, in case of incomplete set of documents or information submitted by the applicant within the application for the Conclusion, as well as in case of provision of the incorrect or distorted information in the application and accompanying documents, the Ministry of Health of the Republic of Uzbekistan within 2 (two) business days provides the applicant with a period of not less than 5 (five) and not more than 30 (thirty) business days to correct mistakes and/or to submit missing documents.

The term of review of the application for the Conclusion is 5 (five) business days. It should be noted that the Conclusion is issued for an unlimited period of time. The Ministry of Health of the Republic of Uzbekistan does not charge any fee for review of the application and/or issuance of the Conclusion.

Rejection of the application for the Conclusion

Within the framework of Regulation, an application for the Conclusion may be rejected on the following grounds:

• Non-compliance of the application with the requirements established by the Regulations. Accordingly, the advertisement in respect of which the applicant intends to obtain the Conclusion must comply with the legislation of the Republic of Uzbekistan;
• Submission of knowingly false or forged information and/or documents;
• Failure to provide corrected information and/or documents within the time period provided by the Ministry of Health of the Republic of Uzbekistan to correct mistakes and/or provide missing documents.

Please be informed, that Regulation prohibits rejection of an application for the Conclusion based on the expediency or impracticality of advertising, as well as for any other reasons not specified in the Regulation.

Reissuance of the Conclusion

Under the Regulation, if case of the Conclusion needs to be reissued, the applicant shall submit the relevant application through the CPS.

Accordingly, if any changes were made in relation to the content of advertising of medicines or biologically active supplements on TV and radio channels, the legal entity will have to reissue the previously issued Conclusion respectively.

Also, it worth noting that according to Annex 18 to the Regulations, in case of changes in the name, legal form or location (postal address) of the legal entity, in the name of which the Conclusion was issued, reissuance of the Conclusion is not required.

Register of Conclusions and the Confidentiality

According to Annex 18 of the Regulation, the Ministry of Health of the Republic of Uzbekistan shall keep an electronic register of issued Conclusions.

Moreover, the Regulation stipulates that the CPS and the Ministry of Health of the Republic of Uzbekistan shall ensure the confidentiality of information obtained as part of the legal entity's application for the Conclusion.

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