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The document ceased to be valid since   January 24, 2017 according to Item 1 of the Order of the Ministry of Economic Development and Trade of Ukraine, the Ministry of Health of Ukraine of December 9, 2016 No. 2042/1314

It is registered

Ministry of yustitsiiukraina

February 4, 2004

No. 50/8749

THE ORDER OF THE STATE COMMITTEE OF UKRAINE CONCERNING REGULATORY POLICY AND THE ENTREPRENEURSHIP, THE MINISTRY OF HEALTH OF UKRAINE

of January 27, 2004 No. 04/42

About approval of the Procedure for control of observance of Licensed conditions of implementation of economic activity on development, production, production, storage, transportation, acquisition, peresylaniye, import, export, leave, destruction of drugs, psychotropic substances and precursors

According to Articles 8, 9 Laws of Ukraine "About licensing of certain types of economic activity", the Presidential decree of Ukraine of May 25, 2000 N721 "Questions of the State Committee of Ukraine concerning Regulatory Policy and Entrepreneurship" and the resolution of the Cabinet of Ministers of Ukraine of November 14, 2000 N1698 "About Approval of the List of Bodies of Licensing" (with changes)

WE ORDER:

1. Approve the Procedure for control of observance of Licensed conditions of implementation of economic activity on development, production, production, storage, transportation, acquisition, peresylaniye, import, export, leave, destruction of drugs, psychotropic substances and precursors (further - the Procedure) which is applied.

2. To inspection department and authorization system of the State committee of Ukraine concerning regulatory policy and entrepreneurship (Apatenko O. P.) and to management of licensing of Public service of medicines and products of medical appointment (Zbrozhek S. I.) in accordance with the established procedure to provide provision of this order on state registration in the Ministry of Justice of Ukraine.

3. To management of licensing of Public service of medicines and products of medical appointment (Zbrozhek S. I.) provide publication of this order in mass media.

4. To impose control of execution of this order on the vice-chairman of the State committee of Ukraine concerning regulatory policy and entrepreneurship Tretyakov S. I. and the deputy minister of health care - the chairman of Public service of medicines and products of medical appointment Pasichnik M. F.

I.o Predsedatel State

committee of Ukraine on questions

regulatory policy and

entrepreneurships

 

 

 

K. O. Vashchenko

Acting Minister

V. V. Zagorodny

Approved by the Order of the State committee of Ukraine concerning regulatory policy and entrepreneurship, the Ministry of Health of Ukraine of January 27, 2004, No. 04/42

Procedure for control of observance of Licensed conditions of implementation of economic activity on development, production, production, storage, transportation, acquisition, peresylaniye, import, export, leave, destruction of drugs, psychotropic substances and precursors

1. General provisions

1.1. This procedure is developed according to requirements:

1.2. Control of observance by subjects of housekeeping (further - licensees) Licensed conditions is performed by Public service of medicines and products of medical appointment (daleegosudarstvenny service) as body of licensing, the State committee of Ukraine concerning regulatory policy and entrepreneurship (further - Gospredprinimatelstva) and its territorial authorities (further - representations) as specially authorized body concerning licensing (further - control facilities) within the powers by carrying out scheduled and unscheduled inspections.

1.3. In this Procedure the terms below are used in such value:

the subject of housekeeping - the legal entity irrespective of its form of business and pattern of ownership performing economic activity registered in the procedure established by the legislation except public authorities and local government bodies, and also the physical person - the subject of business activity;

the licensee - the subject of housekeeping who obtained the license for implementation of economic activity on development, production, production, storage, transportation, acquisition, peresylaniye, import, export, leave, destruction of drugs, psychotropic substances and precursors;

control of observance of Licensed conditions - set of the organizational and legal actions directed to check of observance by licensees of qualification, organizational, special, production and other requirements for implementation of economic activity on development, production, production, storage, transportation, acquisition, peresylaniye, import, export, leave, destruction of drugs, psychotropic substances and precursors;

the inspection statement - the document processed in accordance with the established procedure which is constituted by officials of control facilities by results of check of observance by the licensee of Licensed conditions;

the order about elimination of violations Licensed usloviyresheniye of body of licensing or specially authorized body concerning licensing about need of elimination by the licensee at the scheduled time of violations of Licensed conditions;

further violation of Licensed conditions - making by the licensee during effective period of the license of further violation of certain Licensed conditions after application of sanctions for similar violation;

unauthenticity of data in the documents filed by the subject of housekeeping for receipt of the license - identification of the location of the legal entity or the residence of the physical person - the subject of business activity or the place of the implementation of economic activity which is not specified in the statement or other documents filed by the subject of housekeeping for receipt of the license, and also other disagreements between the data stated in the filed documents and available material, regulatory framework, qualification of personnel (workers) which are established when checking the subject of housekeeping;

failure to provide the message on change of the data specified in documents which were enclosed to the application for issue failure to provide fact litsenziivyyavleniye in the terms determined by the legislation in body of licensing together with the relevant documents of the message in writing on all changes of the data specified in documents which were enclosed to the application for licensing;

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