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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

July 26, 2012

No. 1262/21574

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of July 11, 2012 No. 513

About approval of the Procedure for test before licensing for carrying out economic activity on production of medicines, wholesale, retail trade by medicines

(as amended on 09-11-2016)

According to Articles 10, 19 Laws of Ukraine "About medicines" and for the purpose of conducting check of 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 for carrying out economic activity on production of medicines, wholesale, retail trade by medicines to characteristics of PRIKAZYVAYU:

1. Approve the Procedure for test before licensing for carrying out economic activity on production of medicines, wholesale, retail trade by medicines which is applied.

2. To management of development of the pharmaceutical sector of industry of health care (Konoshevich L. V.) in accordance with the established procedure to provide submission of this order on state registration in the Ministry of Justice of Ukraine.

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 its official publication.

The vice-Prime Minister of Ukraine is the Minister

R.V.Bogatyreva

Approved by the Order of the Ministry of Health of Ukraine of July 11, 2012, No. 513

Procedure for test before licensing for implementation of economic activity on production of medicines, wholesale, retail trade by medicines

І. General provisions

1.1. This Procedure is developed according to Articles 10, 19 Laws of Ukraine "About medicines" and is obligatory for accomplishment by subjects of managing who intend to obtain the license for implementation of economic activity on production of medicines, wholesale, retail trade by medicines or its copy, Gosleksluzhboy and its territorial authorities.

1.2. Terms which are used in this Procedure have such values:

the act - the document processed in accordance with the established procedure which is constituted by officials of control facilities by results of check (the inspection statement of compliance of the subject of managing to the established requirements for industrial production of medicines; the inspection statement of availability of material and technical resources, the qualified personnel necessary for carrying out economic activity on production of medicines in the conditions of drugstore, wholesale and retail trade by medicines; the act of refusal of the subject of managing in conducting check by control facility (appendix 5));

refusal of the subject of managing in conducting check - making of obstacles from the subject of managing 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 carrying out economic activity on production of medicines, wholesale, retail trade by medicines, creation of obstacles in work of officials of control facility from the subject of managing, not appointment as the subject of managing of person authorized by it which has the right to represent the subject of managing during conducting check in case of absence of the head of the subject of managing (legal entity) or the subject of managing - the physical person - the entrepreneur, refusal in provision of documents, information concerning check subject upon the demand of officials of control facility;

discrepancy - failure to carry out by the subject of managing of requirements of Licensed conditions of carrying out economic activity on production of the 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 (further - Licensed conditions) (this determination is applied to industrial production of medicines).

1.3. 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 on carrying out economic activity on industrial production of medicines is established by Gosleksluzhboy on the basis:

the documents filed by the applicant for receipt of the license for carrying out economic activity on industrial production of medicines;

the inspection statement of compliance of the subject of managing to the established requirements for industrial production of medicines (appendix 1).

1.4. Compliance of material and technical resources, qualification of personnel to the established requirements and declared in the documents filed by the applicant for receipt of the license for carrying out economic activity on production of medicines in the conditions of drugstore of wholesale, retail trade by medicines to characteristics is established by Gosleksluzhboy on the basis:

the documents filed by the applicant for receipt of the license for carrying out economic activity on production of medicines in the conditions of drugstore, wholesale, retail trade by medicines;

the inspection statement of availability of material and technical resources, qualified personnel necessary for carrying out economic activity on production of medicines in the conditions of drugstore, wholesale and retail trade by medicines (appendices 2-4).

1.5. The basis for carrying out verification of presence of material and technical resources, qualification of personnel, and also conditions concerning control of quality of medicines which will be made, necessary for carrying out economic activity on production of medicines, wholesale and retail trade by medicines (further - check) is the statement of the subject of managing on licensing for implementation of economic activity on production of medicines, wholesale, retail trade by medicines or the statement for issue of the copy of the license for implementation of economic activity on production of medicines, wholesale, retail trade by medicines which move in Gosleksluzhbu in the form given in appendices 1, 4 to Licensed conditions.

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