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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

(as amended on 21-09-2023)

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. Determine that for action of warlike situation in the territory of Ukraine, in case of lack of technical capability of entering of data into the Register of persons responsible for introduction of medical products, active medical products who implant, and medical products for diagnostics of invitro into the address (further - the Register of persons), within 48 hours and more, person responsible for introduction of medical products, active medical products which implant, and medical products for diagnostics of invitro into the address has the right to give in paper form and on electronic media (with расширением.xls) to Public service of Ukraine on medicines and control of drugs, the notification on entering of information into the Register of persons in the form determined by appendix to this order with properly verified copies of the documents confirming the data specified in the message before introduction of medical products in the address.

Public service of Ukraine on medicines and control of drugs according to the administrator Reestr of persons will immediately promulgate information on lack of technical capability of functioning of Reestr of persons on the website.

In case of lack of technical capability of functioning of the Register of persons within 48 hours and more, information on lack of technical capability of the Register of persons is also posted on the official website of the Ministry of Health of Ukraine.

Public service of Ukraine on medicines and control of drugs in case of receipt of the notification on introduction of medical products in the address submitted in paper form and on electronic media (with расширением.xls), the entering of data into the Register of persons directed at the moment of lack of technical capability, provides its consideration according to the procedure of priority of receipt and entering of information into the Register of persons no later than 12 working days from the moment of emergence of the corresponding technical capability.

3. 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.

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

5. 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 implant, and 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

I. General provisions

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

2. The register of persons of the information and communication system intended for forming and accounting of 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 02, 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 02, 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 implant the Cabinet of Ministers of Ukraine approved by the resolution of October 02, 2013 No. 755 (further - the Technical regulation of rather active medical products which implant).

3. The terms used in this Procedure have the following value:

person responsible for introduction of medical products, active medical products which implant and medical products for diagnostics of in vitro in the address (further - person responsible for introduction of products in the address) - subject of managing which is producer of medical products, medical products for diagnostics of in vitro and active medical products which implant, or his authorized representative;

the electronic office of the user Reestr of persons - Reestr's web interface of persons, the reference to which is posted on the official website of Civil service, is intended for authenticated access for persons responsible for input of products to the address, for accomplishment of the functions directed to realization of own rights and obligations provided by this Procedure by them;

the authorized person from registration - the official of Civil service, authorized to bring, change or delete in the procedure for the information about persons responsible for input of products established by Public service of Ukraine on medicines and control of drugs in the address in the Register of persons.

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