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The document ceased to be valid since  March 28, 2017 according to Item 1 of the Order of the Ministry of Health of Ukraine of January 23, 2017 No. 51

It is registered

Ministry of Justice of Ukraine

December 20, 2012

No. 2124/22436

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of November 30, 2012 No. 979

About approval of the Procedure for import to the territory of Ukraine of the unregistered medical equipment and products of medical appointment

(as amended of the Order of the Ministry of Health of Ukraine of 21.07.2014 No. 510)

According to the paragraph third Item 1 of the Procedure for state registration of medical equipment and products of the medical appointment approved by the resolution of the Cabinet of Ministers of Ukraine of November 9, 2004 No. 1497, Item 3, the subitem 4 of item 4 of the Regulations on the Ministry of Health of Ukraine approved by the Presidential decree of Ukraine of April 13, 2011 No. 467, Item 3, subitems 2, of 13, of the 14th item 4 of the Regulations on Public service of Ukraine on medicines approved by the Presidential decree of Ukraine of April 8, 2011 No. 440, for the purpose of ensuring state regulation of import to the territory of Ukraine of the unregistered medical equipment and products of medical appointment of PRIKAZYVAYU:

1. Approve the Procedure for import to the territory of Ukraine of the unregistered medical equipment and products of medical appointment which is applied.

3. To the head of department of medicines and medical products (Konoshevich L. V.) provide submission of this order on state registration in the Ministry of Justice of Ukraine.

4. To impose control over the implementation of this order on the deputy minister - the chief of staff of Bogachyov R. M.

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

Acting Minister

O. Tolstanov

It is approved:

Chairman of Public service of Ukraine

on medicines O. Solovyov

 

Approved by the Order of the Ministry of Health of Ukraine of November 30, 2012, No. 979

Procedure for import to the territory of Ukraine of the unregistered medical equipment and products of medical appointment

1. This Procedure establishes requirements concerning import of the unregistered medical equipment and products of medical appointment and extends to subjects of managing who intend to import the unregistered medical equipment and products of medical appointment.

2. In this Procedure terms are used in such values:

the applicant - the subject of managing who intends to import the unregistered medical equipment and products of medical appointment to the territory of Ukraine;

the receiver - the subject of managing who acquired the right to import to the territory of Ukraine of the unregistered medical equipment and products of medical appointment;

study of documents concerning possibility of import to the territory of Ukraine of the unregistered medical equipment and products of medical appointment - certain sequence of actions which are carried out by Gosleksluzhboy of Ukraine for the purpose of establishment of possibility of import to the territory of Ukraine of the unregistered medical equipment and products of medical appointment based on the documents filed by the applicant concerning quality and safety of the unregistered medical equipment and products of medical appointment which are offered to import to the territory of Ukraine, and their check to compliance to the legislation;

the notification - the letter with indication of information concerning opportunity or impossibility of import to the territory of Ukraine of the unregistered medical equipment and products of medical appointment which is issued by results of the corresponding study of documents on free basis in the form given in appendix 1 to this Procedure.

3. Medical equipment and products of medical appointment which are not registered in Ukraine according to the legislation can be imported on the territory of Ukraine:

a) for the purpose of state registration (re-registration) of medical equipment and products of medical appointment;

b) for the purpose of participation in the technical assistance program, in programs of international cooperation according to international treaties;

c) in case of natural disaster, accidents, epidemics and epizooty, environmental, technogenic catastrophes, conducting anti-terrorist operation, introduction of warlike, emergency state.

4. For receipt of the notification the applicant submits to Gosleksluzhbu of Ukraine the application addressed to the Chairman Gosleksluzhby of Ukraine in whom the purpose of import of the unregistered medical equipment and products of medical appointment, their name, quantity, predpriyatiyeproizvoditel, the manufacturing country, the list of accompanying documents are specified.

5. Documents which list is specified in appendix 2 to this Procedure are enclosed to the application.

All documents are filed in one copy, in translation into state language according to the Law of Ukraine "About the principles of the state language policy" - the original or copies certified in accordance with the established procedure.

In case of provision of incomplete set of documents the statement remains without consideration what the applicant is informed on.

6. Study of documents concerning possibility of import to the territory of Ukraine of the unregistered medical products performs Gosleksluzhba of Ukraine.

7. By results of study of the documents filed by the applicant on import to the territory of Ukraine of the unregistered medical equipment and products of medical purpose of Gosleksluzhba of Ukraine provides to the applicant the notification (appendix 1) concerning possibility of import to the territory of Ukraine of the unregistered medical equipment and products of medical appointment.

8. The bases for provision to the applicant of the notification concerning impossibility of import to the territory of Ukraine of the unregistered medical equipment and products of medical appointment is establishment during study of the facts of unauthenticity of provided information concerning quality and safety of the unregistered medical equipment and products of medical appointment which are offered to import to the territory of Ukraine, or discrepancy to their legislation.

9. Gosleksluzhby's notification of Ukraine is drawn up signed by the Chairman Gosleksluzhby of Ukraine or his deputies according to distribution of the functional obligations approved by Gosleksluzhby's order of Ukraine.

10. The term of consideration of the complete document package determined in appendix 2 to this Procedure and provisions of the notification concerning possibility of import to the territory of Ukraine of the unregistered medical equipment and products of medical appointment shall not exceed 5 working days.

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