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

of February 20, 2001 No. 39/66

About approval 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 article 8 of the Law of Ukraine "About licensing of certain types of economic activity" and in pursuance of the resolution of the Cabinet of Ministers of Ukraine of November 14, 2000 N1698 "About Approval of the List of Bodies of Licensing"

WE ORDER:

1. Approve Licensed conditions of implementation of economic activity on development, production, production, storage, transportation, acquisition, to peresylaniye, import, export, leave, destruction of drugs, psychotropic substances and precursors (are applied).

2. To management of licensing of types of economic activity of Department of registration and licensing of the State committee of Ukraine concerning regulatory policy and entrepreneurships (Efremov O. V.), to management of accreditation and licensing of State department on control of quality, safety and production 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 the head of department of accreditation and licensing of State department on control of quality, safety and production of medicines and products of medical appointment (Zbrozhek S. I.) provide the 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 First Deputy Chairman of State department on control of quality, safety and production of medicines and products of medical appointment Yevtushenko O. I.

Approved the Order of the State committee of Ukraine concerning regulatory policy and entrepreneurship, the Ministry of Health of Ukraine of February 20, 2001 No. 39/66

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. These Licensed conditions are developed according to Bases of the legislation of Ukraine on health care, the Laws of Ukraine: "About entrepreneurship", "About medicines", "About the companies in Ukraine", "About the address in Ukraine of drugs, psychotropic substances, their analogs and precursors", "About licensing of certain types of economic activity", determine licensed conditions of implementation of economic activity on development, production, storage, transportation, acquisition, peresylaniye, import, export, leave, destruction of drugs, psychotropic substances and precursors.

1.2. Action of these Licensed conditions extends to all subjects of housekeeping registered in the procedure established by the legislation as legal entities, irrespective of their form of business and pattern of ownership which are carrying out the economic activity connected with development, production, production, storage, transportation, acquisition, peresylaniye, import, export, leave, destruction of the drugs allowed for use in Ukraine, the psychotropic substances and precursors specified in the List of drugs, psychotropic substances and precursors approved by the resolution of the Cabinet of Ministers of Ukraine of May 6, 2000 N770 (further - the List).

1.3. According to the legislation are subject to licensing: development, production, production, storage, transportation, acquisition, peresylaniye, import, export, leave, destruction of drugs, psychotropic substances and precursors.

1.4. The type of economic activity (fully or partially) which is subject to licensing shall be specified in constituent documents of the subject of housekeeping.

1.5. Licensing of the specified type of economic activity is control facility of the state behind observance by the licensee of requirements of the legislation to the activities connected with development, production, production, storage, transportation, acquisition, peresylaniye, import, export, leave, destruction of drugs, psychotropic substances and precursors.

1.6. Documents acceptance, going for receipt of the license, licensing, renewal and cancellation of the license, issue of duplicates of licenses, conducting licensed cases and licensed registers, control within the competence of observance by licensees of licensed conditions, issue of orders about elimination of violations of licensed conditions is carried out by State department on control of quality, safety and production of medicines and products of medical appointment (further - State department).

Organizational requirements

1.7. In the license for development, production, production, storage, transportation, acquisition, peresylaniye, import, export, leave, destruction of drugs, psychotropic substances and precursors groups of narcotic (psychotropic) medicines or precursors, type of economic activity shall be specified (fully or partially) which can be performed by the subject of housekeeping, depending on availability and compliance of material and technical resources, the regulating documentation, qualification of specialists.

1.8. The license of State department is the single document of allowing nature granting the right to implementation of economic activity on development, production, production, storage, transportation, acquisition, peresylaniye, import, export, leave, destruction of drugs, psychotropic substances and precursors and resolving implementation of the specified type of activity in all territory of Ukraine.

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