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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

March 5, 2013

No. 358/22890

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of February 27, 2013 No. 168

About approval of the Procedure for test before licensing for implementation of economic activity on import of medicines

(as amended of the Order of the Ministry of Health of Ukraine of 09.11.2016 No. 1195)

According to article 17 of the Law 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 imported on the territory of Ukraine I ORDER to the established requirements and characteristics declared in the documents filed by the applicant for receipt of the license for implementation of economic activity on import of medicines:

1. Approve the Procedure for test before licensing for implementation of economic activity on import of medicines which is applied.

2. (L. Konoshevich) to provide to management of medicines and medical products provision of this order in the procedure established by the legislation 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.

Minister

R. Bogatyreva

Approved by the Order of the Ministry of Health of Ukraine of February 27, 2013, No. 168

Procedure for test before licensing for implementation of economic activity on import of medicines

I. General provisions

1.1. This Procedure is developed according to article 17 of the Law 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 import of medicines or its copy, Gosleksluzhboy and its territorial authorities).

1.2. Compliance of material and technical resources, qualification of personnel, and also conditions concerning control of quality of medicines which will be imported on the territory of Ukraine to the established requirements and declared in the documents filed by the applicant for receipt of the license to characteristics on implementation of economic activity on import of medicines is established by Gosleksluzhboy on the basis:

statements for licensing (copy of the license) on import of medicines;

the documents filed by the applicant for receipt of the license (the copy of the license) for implementation of economic activity on import of medicines;

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

1.3. 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 imported on the territory of Ukraine, necessary for implementation of economic activity on import of medicines (further - check) is the statement of the subject of managing for licensing on import of medicines or the statement for issue of the copy of the import license of medicines which move in Gosleksluzhbu as in body of licensing, in the form given in appendices 1 and 5 to the Licensed conditions of implementation of economic activity on import of medicines approved by the order of the Ministry of Health of Ukraine of February 20, 2013 No. 143, registered in the Ministry of Justice of Ukraine on February 22, 2013 for No. 307/22839 (further - Licensed conditions).

1.4. In case of lack of the bases for leaving of the statement for licensing (the copy of the license) without consideration of Gosleksluzhba within three working days from the date of receipt of the statement of the subject of managing for licensing (the copy of the license) in writing reports in territorial authority of Gosleksluzhby about need of conducting check or will organize conducting such check.

1.5. It is performed by officials of Gosleksluzhby and/or territorial authorities of Gosleksluzhby (further - control facilities) no later than the sixth working day from the date of receipt of the statement of the subject of managing for licensing (the copy of the license).

1.6. The term of implementation of check cannot exceed three working days.

1.7. 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 behind results of check (the inspection statement of compliance of the subject of managing to the established requirements for import of medicines; the act of refusal in conducting check by control facility);

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 implementation of economic activity on import of medicines, not appointment as the subject of managing of the person authorized by it having 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.

ІІ. Conducting check

2.1. The Gosleksluzhba or territorial authority of Gosleksluzhby issues the order which shall contain the name of the subject of managing concerning which check, subject of check and surname, names and middle names of officials which will perform will be performed.

2.2. Based on the order the certificate on conducting check which is signed by the head or the deputy manager of control facility is drawn up and makes sure seal of control facility in the form given in appendix 2 to this Procedure.

2.3. Certificates are registered in register of certificates on conducting check of subjects of managing which submit the application for licensing (the copy of the license) for implementation of economic activity on import of medicines which pages shall be numbered, strung together and under seal in the form given in appendix 3 to this Procedure.

The certificate is effective only during the check implementation term specified in it.

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