LAW OF UKRAINE

of December 20, 2011 No. 4196-VI

About introduction of amendments to some laws of Ukraine in the field of health care concerning strengthening of control of drug circulation, foodstuff for special dietary consumption, functional foodstuff and dietary additives

The Verkhovna Rada of Ukraine decides:

I. Make changes to such laws of Ukraine:

1. Part third of Article 19 of Bases of the legislation of Ukraine on health care (1993, No. 4, the Art. 19) after the word "State" to add sheets of the Verkhovna Rada of Ukraine with the words "provides observance of requirements of the law concerning restriction of advertizing of medicines and".

2. In the Law of Ukraine "About medicines" (Sheets of the Verkhovna Rada of Ukraine, 1996, No. 22, Art. 86; 1997, No. 15, Art. 115; 2006, No. 22, Art. 184):

Article 3 part one after the word in "way" to add 1) with words "maintaining the State register of medicines of Ukraine with ensuring public access for persons to it";

2) in Article 10:

add part one with the offer of such content: "The list of forms of the medicines permited to production to the licensee and also special conditions of carrying out activities is specified in appendix to the license";

the second to add part with the offer of such content: "Compliance of material and technical resources, qualification of personnel, and also conditions concerning 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 by body of licensing according to the procedure, determined by the central executive body in health care industry";

Part one of Article 17 to add 3) with the offer of such content: "The procedure for import of medicines to the territory of Ukraine is established by the Cabinet of Ministers of Ukraine";

4) in Article 19:

in word part one "physical persons - subjects of business activity" shall be replaced with words "physical persons - entrepreneurs";

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