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Action of the document is cancelled since May 21, 2017 according to the Order of the Cabinet of Ministers of Ukraine of March 10, 2017 No. 169-r

It is registered

Ministry of Justice of Ukraine

December 7, 2011

No. 1421/20159

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of October 31, 2011 No. 724

About approval of the Procedure for control of observance of Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade by medicines

(as amended on 02-09-2014)

According to Articles 6, 20, 21 Law of Ukraine "About licensing of certain types of economic activity", the Law of Ukraine "About the main beginnings of the state supervision (control) in the field of economic activity", the resolution of the Cabinet of Ministers of Ukraine of 14.11.2000 No. 1698 "About approval of the list of bodies of licensing" (with changes) PRIKAZYVAYU:

1. Approve the Procedure for control of observance of Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade by medicines (further - the Procedure for control) which is applied.

3. To the First Deputy Chairman of Public service of Ukraine on medicines Demchenko I. B. 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.

4. To impose control over the implementation of this order on the First Deputy Chairman of Public service of Ukraine on medicines Demchenko I. B.

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

Minister

O. V. Anishchenko

Approved by the Order of the Ministry of Health of Ukraine of October 31, 2011, No. 724

Procedure for control of observance of Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade by medicines

I. General provisions

1.1. This Procedure No. 1698 "About approval of the list of bodies of licensing" is developed according to the Laws of Ukraine "About licensing of certain types of economic activity", "About the main beginnings of the state supervision (control) in the field of economic activity", Bases of the legislation of Ukraine on health care, the resolution of the Cabinet of Ministers of Ukraine of 14.11.2000.

1.2. Action of this Procedure extends to all subjects of managing (legal entities and physical persons - entrepreneurs) who obtained the license for implementation of economic activity on production of medicines, wholesale, retail trade by medicines in accordance with the established procedure.

1.3. Control of observance by subjects of managing of Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade by medicines (further - Licensed conditions) within the powers by carrying out scheduled and unscheduled inspections control facilities perform: Public service of Ukraine on quality control of medicines (further - Gosleksluzhba) as body of licensing and its territorial authorities - the state inspectorates for quality control of medicines in the Autonomous Republic of Crimea, areas, the cities of Kiev and Sevastopol (further - territorial authorities of Gosleksluzhby).

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

the act - the document processed in accordance with the established procedure which is constituted by officials of control facilities behind results of check of observance by the licensee of Licensed conditions (the inspection statement of observance by the licensee of Licensed conditions; act of further violation by the licensee of Licensed conditions; the act of factual determination of transfer of the license or its copy to other legal entity or physical person for implementation of economic activity; the act of detection of false information in the documents filed by the subject of managing for receipt of the license; act of failure to carry out of the order of elimination of violations of Licensed conditions; the act of refusal of the licensee in conducting check by body of licensing or specially authorized body concerning licensing; the act of impossibility of the licensee to provide accomplishment of the Licensed conditions established for certain type of economic activity);

refusal of the licensee in conducting check - making of obstacles from the licensee in access for officials of control facility to its territory and/or to buildings, constructions, rooms of the subject of managing which are used for implementation of economic activity on production of medicines, wholesale, retail trade by medicines, creation of obstacles in work of officials of control facility from the licensee, not appointment as the licensee of person authorized by it which has the right to represent the licensee when conducting check in case of absence of the head of the licensee (legal entity) or the licensee - the physical person - the entrepreneur, refusal in provision of documents, information concerning check subject upon the demand of officials of control facility;

control of observance of Licensed conditions - set of the organizational and legal actions directed to check of observance by licensees of organizational, qualification and other special requirements for implementation of economic activity on production of medicines, wholesale, retail trade by medicines;

critical violation of Licensed conditions of industrial production of medicines or wholesale trade by medicines - violation (discrepancy) of Licensed conditions or requirements of the registration file on medicine which brought or can lead to production of low-quality medicine, wholesale, retail trade by low-quality medicines which can do harm for health or human life (determination is applied to industrial production of medicines or wholesale trade by medicines);

the licensee - the subject of managing who obtained the license for implementation of certain type of economic activity which is subject to licensing;

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

impossibility of the licensee to provide accomplishment of Licensed conditions lack of material and technical resources (rooms, the equipment) for implementation of production of medicines, wholesale, retail trade with medicines in the places of implementation of economic activity specified in documents which are enclosed to the application for receipt of the license; absence of specialists who shall have the corresponding vocational education and meets single qualification requirements;

non-presentation of the message on change of the data specified in documents which were enclosed to the application for licensing - identification of the fact of non-presentation in the time 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;

insignificant violation of Licensed conditions of industrial production of medicines or wholesale trade by medicines - violation (discrepancy) which cannot lead to production of low-quality medicine to wholesale, retail trade by low-quality medicines and can be eliminated at the time of check or during the shortest period and which does not belong to critical or fundamental breaches (determination is applied to industrial production of medicines or wholesale trade by medicines);

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