ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of July 11, 2012 No. 515

About modification of Licensed conditions of carrying out economic activity on production of medicines, wholesale, retail trade by medicines

According to the Regulations on the Ministry of Health of Ukraine approved by the Presidential decree of Ukraine of April 13, 2011 No. 467, article 8 of the Law of Ukraine "About licensing of certain types of economic activity" and Articles 10, 19 Laws of Ukraine "About medicines" ORDER:

1. Approve Changes to the Licensed conditions of carrying out economic activity on production of medicines, wholesale, retail trade by medicines approved by the order of the Ministry of Health of Ukraine of October 31, 2011 No. 723, registered in the Ministry of Justice of Ukraine on December 07, 2011 for No. 1420/20158, which are applied.

2. To the First Deputy Chairman of Public service of Ukraine on lekarstvenna to Demchenko I. B. means. in accordance with the established procedure to provide submission of this order on state registration in the Ministry of Justice of Ukraine and the publication of this order in printing mass media.

3. To impose control over the implementation of this order on the deputy minister - the chief of staff of Bogachyov R. M.

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

Approved by the Order of the Ministry of Health of Ukraine of July 11, 2012 No. 515

Changes to the Licensed conditions of carrying out economic activity on production of medicines, wholesale, retail trade by medicines approved by the order of the Ministry of Health of Ukraine of October 31, 2011 No. 723, registered in the Ministry of Justice of Ukraine on December 07, 2011 for No. 1420/20158

1. In the Section I:

1.1. To add Item 1.8 after paragraph one with the paragraph the second such content:

"Data signed by the applicant - the subject of managing about availability of material and technical resources and qualified personnel move in the forms given in appendices 9-11".

With respect thereto paragraphs two, third Item 1.8 to consider respectively paragraphs the third, fourth.

1.2. Add Item 1.11 with new paragraphs of such content:

"The basis for licensing for carrying out economic activity on wholesale, retail trade by medicines is availability of material and technical resources, qualified personnel (appendices 9-11) which compliance to the established requirements and declared in the documents filed by the applicant for receipt of the license to characteristics is subject to obligatory check before licensing within the terms provided for licensing at the venue of activities by Gosleksluzhboy of Ukraine or its territorial authorities - public services on medicines in the Autonomous Republic of Crimea, areas, the cities of Kiev and Sevastopol.

The basis for licensing for production of medicines is availability of the corresponding material and technical resources, qualified personnel, and also conditions on control of quality of medicines which will be made. Compliance of material and technical resources, qualification of personnel, and also conditions on control of quality of medicines which will be made to the established requirements and declared in the documents filed by the applicant for receipt of the license to characteristics is subject to obligatory check before licensing within the terms provided for licensing at the venue of activities Gosleksluzhboy of Ukraine according to the procedure, certain MZ of Ukraine.".

1.3. Add the Section after Item 1.16 with new Item 1.17 of such content:

"1.17. The license for production of medicines is granted taking into account the list of dosage forms and special conditions of carrying out economic activity which are specified in stand-alone programs to the license for production of medicines. Appendix to the license for carrying out economic activity on production of medicines (appendix 12) is drawn up for each specific location of the subject of managing and/or its isolated structural division (in the presence) depending on the place of implementation of production of medicines. Change of the list of the dosage forms permited to production to the licensee and also conditions of carrying out activities for production of medicines is the change connected with carrying out economic activity by the licensee of certain type.

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