ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of November 2, 2020 No. 2485

About approval of Changes in the Procedure for maintaining the Register of persons responsible for input of medical products, active medical products who implant also medical products for diagnostics of in vitro into the address, forms of notifications, lists 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 and Item 1 of the Actions plan on application 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 to in vitro and Item 1 of the Actions plan on application 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 rather active medical products which implant, and to Item 1 of the Actions plan on application of the Technical regulation of rather active medical products which implant the approved resolution of the Cabinet of Ministers of Ukraine of October 2, 2013 No. 755, to the subitem 6 of Item 4, to the subitem 16 of Item 4, to Item 8 of the Regulations on the Ministry of Health of Ukraine approved by the resolution of the Cabinet of Ministers of Ukraine of March 25, 2015 No. 267 (in edition of the resolution of the Cabinet of Ministers of Ukraine of January 24, 2020 to No. 90), to Item 1 of the resolution of the Cabinet of Ministers of Ukraine of December 16, 2015 No. 1057 "About determination of fields of activity in which the central executive bodies and the Security Service of Ukraine perform functions of technical regulation", I ORDER:

1. Approve Changes in the Procedure for maintaining the Register of persons responsible for input of medical products, active medical products who implant also medical products for diagnostics of in vitro into the address, forms of notifications, lists of data which are stored in it, and the mode of access to them, No. approved by the order of the Ministry of Health of Ukraine of February 10, 2017 122, registered in the Ministry of Justice of Ukraine on March 07, 2017 for No. 317/30185, which are applied.

2. To management of provision of medicines (Komarida A. A.) provide in accordance with the established procedure 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 concerning the European integration Ivashchenko I. A.

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

Approved by the Order of the Ministry of Health of Ukraine of November 2, 2020 No. 2485

Changes in the Procedure for maintaining the Register of persons responsible for input of medical products, active medical products who implant also medical products for diagnostics of in vitro into the address, forms of notifications, lists of data which are stored in it, and the mode of access to them

1. To state paragraph two of Item 3 in the following edition:

"For the purposes of this Procedure the term "the established requirements" is used in the value given in the Law of Ukraine "About the state market supervision and control of non-food products", terms of "input in turnover", "producer", "medical product", "authorized representative", "medical product for diagnostics of in vitro", "active medical product which is implanted" are used in the values given in the Technical regulation of rather medical products, the Technical regulation of rather medical products for diagnostics of in vitro, the Technical regulation of rather active medical products which implant.".

2. In Item 12 to replace figure "2" with figures "10".

3. Add with Item 15 of the following content:

"15. Information exception of the Register of persons is performed in the presence of the bases determined in the Technical regulation of rather medical products, the Technical regulation of rather medical products for diagnostics of in vitro, the Technical regulation of rather active medical products which implant after adoption of the order of Gosleksluzhby which is issued according to the made decision.

The Gosleksluzhba within 10 working days from the date of emergence of the bases for exception of data of the Register of persons notifies person responsible for input of products in the address, about such bases in writing and electronic means of communication.

The Gosleksluzhba no later than the next working day from the date of print of cliche of calendar stamp on envelope which sends the notification to the person responsible for input of products to the address changes the status of information in the Register of persons, namely: in information line item in the column "Status" the words "Check" and date of the last day of the expiration during which person responsible for input of products in the address, can present Gosleksluzhbe information which confirms or confutes the bases for information exception of the Register of persons are specified.

Person responsible for input of products in the address, within 30 working days from the date of print of cliche of calendar stamp on envelope which sends the notification in writing provides to Gosleksluzhbe information which confirms or confutes the bases for information exception of the Register of persons.

In case of lack of additional data from the face, responsible for input of products in the address, or letters with reasons for the terms necessary for their preparation, no later than the next working day from the date specified in information line item in the column "Status", Gosleksluzhba makes the decision on information exception of the Register of persons.

Acceptance term can be once extended by Gosleksluzhboy of the decision on information exception of the Register of persons for 30 working days in case of receipt from the face, responsible for input of products in the address, letters with reasons for the terms necessary for preparation of additional data.

The Gosleksluzhba no later than the next working day changes the status of information in the Register of persons from registration date of the order according to which information is excluded from the Register of persons, namely: in information line item in the column "Status" words are specified "Is excluded", date and number of the order.

In case of modification of the Register of persons corrections of technical nature are allowed.

The Gosleksluzhba within 10 working days from registration date of the order notifies person responsible for input of products in the address, about exception of data of the Register of persons in writing and electronic means of communication.

In case of the termination of activities of person responsible for input of products in the address, the notification on information exception of the Register of persons does not go.".

4. In appendices to the Procedure:

1) the table of appendix 1 to add with columns 11, 12 following contents:

"

";

2) in the name of appendix 2 words", forms of notifications, lists of data which are stored in it, and the mode of access to them" to exclude;

The table of appendix 2 to add 3) with the column 9 of the following content:

"

".

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