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It is registered

Ministry of Justice of Ukraine

March 7, 2017

No. 317/30185

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of February 10, 2017 No. 122

About approval of the Procedure for maintaining the Register of persons responsible for introduction of medical products, active medical products who are implanted also medical products for diagnostics of in vitro into the address, forms of messages, the list of data which are stored in it, and the mode of access to them

According to Item 31 of the Technical regulation of rather medical products approved by the resolution of the Cabinet of Ministers of Ukraine of October 2, 2013 No. 753, to Item 23 of the Technical regulation of rather medical products for diagnostics of in vitro approved by the resolution of the Cabinet of Ministers of Ukraine of October 2, 2013 No. 754, to Item 35 of the Technical regulation of carrying out active medical products which are implanted of the Cabinet of Ministers of Ukraine approved by the resolution of October 2, 2013 No. 755, I order:

1. Approve the Procedure for maintaining the Register of persons responsible for introduction of medical products, active medical products who are implanted also medical products for diagnostics of in vitro into the address, forms of messages, the list of data which are stored in it, and the mode of access to them which is applied.

2. In accordance with the established procedure to provide to management of pharmaceutical activities and quality of pharmaceutical products submission of this order on state registration in the Ministry of Justice of Ukraine.

3. To impose control of execution of this order on the deputy minister Ilik R. R.

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

Acting minister

V. Suprun

Approved by the Order of the Ministry of Health of Ukraine of February 10, 2017, No. 122

Procedure for maintaining the Register of persons responsible for introduction of medical products, active medical products who are implanted also medical products for diagnostics of in vitro into the address, forms of messages, the list of data which are stored in it, and the mode of access to them

1. This Procedure establishes the procedure of forming and maintaining the Register of persons responsible for introduction of medical products, active medical products who are implanted also medical products for diagnostics of in vitro into the address (further - the Register of persons), forms of messages, the list of data which are stored in this Register, and access to it.

2. The register of persons is the electronic database which contains the data specified in Item 31 of the Technical regulation of rather medical products approved by the resolution of the Cabinet of Ministers of Ukraine of October 2, 2013 No. 753 (further - the Technical regulation of rather medical products), Item 23 of the Technical regulation of rather medical products for diagnostics of in vitro approved by the resolution of the Cabinet of Ministers of Ukraine of October 2, 2013 No. 754 (further - the Technical regulation of rather medical products for diagnostics of in vitro) and Item 35 of the Technical regulation of rather active medical products which are implanted, the Cabinet of Ministers of Ukraine approved by the resolution of October 2, 2013 No. 755 (further - the Technical regulation of active medical products which are implanted).

3. In this Procedure the term "person responsible for introduction of medical products, medical products for diagnostics of in vitro and active medical products which are implanted, into turnover" is applied as subject of managing which is producer of medical products, medical products for diagnostics of in vitro and active medical products which are implanted or his authorized representative.

For the purposes of this Procedure for determination "introduction into circulation", "producer", "medical product", "authorized representative", "medical product for diagnostics of in vitro", "active medical products which are implanted" are used in the values given in the Technical regulation on medical products, the Technical regulation of rather medical products for diagnostics of in vitro, the Technical regulation of rather active medical products which are implanted.

4. Data are entered by Gosleksluzhboy based on the notification from persons responsible for introduction of medical products, medical products for diagnostics of in vitro and active medical products which are implanted (further in the Register of persons - product) in the address which contains information specified in paragraph one of Item 31 of the Technical regulation of rather medical products, paragraphs the first the fifth Item 23 of the Technical regulation of rather medical products for diagnostics of in vitro and also Item 33 of the Technical regulation of rather active medical products which are implanted.

5. The register of persons creates and conducts Gosleksluzhba in the form given in appendix 1 to this Procedure.

6. The register of persons is kept in state language.

7. The notification on entering of information into the Register of persons (further - the notification) containing information specified in paragraph one of Item 31 of the Technical regulation of rather medical products, paragraphs the first - the fifth Item 23 of the Technical regulation of rather medical products for diagnostics of in vitro, and also Item 33 of the Technical regulation of rather active medical products which are implanted moves in Gosleksluzhbu before introduction of products in the address in the form given in appendix 2 to this Procedure.

Documents, the confirmatory data specified in it can be attached to the notification.

In case of the submission of the notification and documents confirming the data specified in it (in case of their availability), the authorized representative to them in addition provides to effective the written order (the power of attorney, the agreement, the contract, etc.) certified in accordance with the established procedure from the producer from his name.

8. The notification goes to Gosleksluzhbu in one copy in state language on paper and electronic media.

9. Entering of information or changes into the Register of persons is performed by Gosleksluzhboy within 10 working days from the date of receipt such information or changes.

10. The bases for leaving of the notification without consideration are:

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