Unofficial transfer (c) Soyuzpravoinform LLC

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of November 25, 2021 No. 2609

About modification of the Procedure for carrying out clinical testing of medicines and examination of materials of clinical testing

According to article 7 of the Law of Ukraine "About medicines", for the purpose of enhancement of process of document flow in case of submission of documents (materials) for performing clinical trials of medicines I ORDER:

1. Bring in Item 7.1 of the Section VII of the Procedure for the carrying out clinical testing of medicines and examination of materials of clinical testing approved by the order of the Ministry of Health of Ukraine of September 23, 2009 No. 690, No. 1010/17026 registered in the Ministry of Justice of Ukraine on October 29, 2009 (in edition of the order of the Ministry of Health of Ukraine of July 12, 2012 No. 523) the following changes:

Paragraph one to state 1) in the following edition:

"7.1. For carrying out clinical testing of medicines the applicant submits in paper or electronic form to TsOIV documents (materials) of clinical testing specified in subitems 7.1.1 and 7.1.2 of this Item, and to the Center - specified in subitems 7.1.3-7.1.21 of this Item inclusive. Documents (materials) of clinical testing can be filed by the applicant electronically if technically possible.";

To add 2) with the new paragraph of the following content:

"Documents (materials) of clinical testing include:".

2. (Zadvornykh I. S.) in accordance with the established procedure to provide to management of provision of medicines submission of this order on state registration in the Ministry of Justice of Ukraine.

3. To impose control over the implementation of this order on the First Deputy minister Komaridu A. A.

4. This order becomes effective from the date of its official publication.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info