Follow in here monthly digest to be updated with the latest news from Ukraine

Amendments were made to the resolutions of the Cabinet of Ministers, which approved medical technical regulations № 753, 754, 755.

According to the information posted on the official website of the Cabinet of Ministers of Ukraine at https://www.kmu.gov.ua/npas/pro-vnesennya-zmin-do-deyakih-postanov-kabinetu-ministriv-ukrayini-347060520, 06 On May 2020, at the regular sitting of the Cabinet of Ministers of Ukraine, the Resolution of the Cabinet of Ministers of Ukraine “On Amendments to Certain Resolutions of the Cabinet of Ministers of Ukraine” № 347 (hereinafter – the Resolution of the Cabinet of Ministers № 347) was adopted.

The Cabinet of Ministers of Ukraine (CMU) by Resolution of 06.05.2020 № 347 amended the resolutions approving the technical regulations № 753, №754 and №755.

Thus, these three resolutions are supplemented by new paragraphs of the following content in terms of recognition by the conformity assessment body of the results of conformity assessment conducted by foreign accredited conformity assessment bodies:

№ 753 –

«2.5. To establish that the introduction into circulation and / or operation of medical devices / systems of medical devices / procedural sets purchased by a person authorized to make purchases in the field of health care, in accordance with the list determined by the Cabinet of Ministers of Ukraine, in respect of which 15–19 of the Technical Regulation approved by this Resolution shall be permitted subject to the recognition by the designated conformity assessment body of the results of the conformity assessment carried out by foreign accredited conformity assessment bodies in accordance with requirements of parts one and three of Article 45 of the Law of Ukraine “On technical regulations and conformity assessment”. “;

№ 754 –

«2.2. To establish that at the time of the Law of Ukraine “On Amendments to Certain Laws of Ukraine Concerning Ensuring Timely Access of Patients to Necessary Medicines and Medical Devices through Public Procurement with the Involvement of Specialized Organizations Carrying Out” for in vitro diagnostics, which are subject to procurement in accordance with procurement agreements concluded by the Ministry of Health with specialized procurement organizations, which are not performed in The requirements of paragraphs 10-13 of the Technical Regulations approved by this resolution are permitted provided that the designated conformity assessment body recognizes the results of the conformity assessment carried out by foreign accredited conformity assessment bodies in accordance with the Law of Ukraine in accordance with Article 45 and compliance ».»;

№ 755 –

«2.4. To establish that the introduction into circulation and / or operation of active implantable medical devices, which are purchased by a person authorized to make purchases in the field of health care, in accordance with the list determined by the Cabinet of Ministers of Ukraine21 for which the requirements 19 The technical regulations approved by this resolution shall be permitted provided that the designated conformity assessment body recognizes the results of the conformity assessment carried out by foreign accredited conformity assessment bodies in accordance with the requirements of parts per. second and third of Article 45 of the Law of Ukraine “On technical regulations and conformity assessment.”

In addition, a number of points were set out in the updated version:

№ 753 –

23. To establish that during the Law of Ukraine “On Amendments to Certain Laws of Ukraine on Ensuring Timely Access of Patients to Necessary Medicines and Medical Devices through Public Procurement with the Involvement of Specialized Procurement Organizations” the introduction into circulation and / or operation medical devices to be procured in accordance with procurement agreements concluded by the Ministry of Health with specialized procurement organizations for which no The requirements of paragraphs 15-19 of the Technical Regulations approved by this resolution are allowed provided that the designated conformity assessment body recognizes the results of conformity assessment conducted by foreign accredited conformity assessment bodies in accordance with the requirements of parts one and three of Article 45 of the Law of Ukraine “On Technical Regulations and conformity assessment ”;

№ 754 –

2.2. To establish that during the Law of Ukraine “On Amendments to Certain Laws of Ukraine on Ensuring Timely Access of Patients to Necessary Medicines and Medical Devices through Public Procurement with the Involvement of Specialized Procurement Organizations” the introduction into circulation and / or operation in vitro diagnostic medical devices to be procured in accordance with procurement agreements entered into by the Ministry of Health with specialized procurement organizations in respect of which the requirements of paragraphs 10-13 of the Technical Regulation approved by this resolution are not met, is allowed subject to recognition by the designated conformity assessment body of the results of conformity assessment conducted by foreign accredited conformity assessment bodies in accordance with parts one and three of Article 45 of the Law of Ukraine “On technical regulations and conformity assessment”;

№ 755 –

2.2. To establish that during the Law of Ukraine “On Amendments to Certain Laws of Ukraine on Ensuring Timely Access of Patients to Necessary Medicines and Medical Devices through Public Procurement with the Involvement of Specialized Procurement Organizations” the introduction into circulation and / or operation active implantable medical devices subject to procurement in accordance with procurement agreements entered into by the Ministry of Health with specialized organizations Invoices for which the requirements of paragraphs 19-21 of the Technical Regulation approved by this resolution are not met are allowed subject to recognition by the designated conformity assessment body of the results of conformity assessment conducted by foreign accredited conformity assessment bodies in accordance with parts one and three of Article 45 of the Law of Ukraine “On technical regulations and conformity assessment”.

In the text of the technical regulations, the reference norms were replaced by the Law of Ukraine “On the Principles of the State Language Policy” instead of the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language”.

Resolution № 347 was adopted at the Government meeting on May 6, despite the absence of this issue on the agenda published on the official website of the Cabinet of Ministers of Ukraine at the following link https://www.kmu.gov.ua/meetings/zasidannya-kabinetu-ministriv-ukrayini-05-05-2020.

Resolution of the Cabinet of Ministers № 347 is a regulatory act and has a wide range of actions.

Resolution of the Cabinet of Ministers № 347 was not submitted for public discussion and was not made public until its adoption by the Government of Ukraine.

Resolution of the Cabinet of Ministers № 347 shall enter into force on the day of its publication. A number of its items, namely sub-item 1 of item 1, sub-item 1 of item 2 and sub-item 1 of item 3 of the changes approved by this resolution, have limited scope in time and will operate until March 31, 2022.

The Resolution of the Cabinet of Ministers № 347 has not been officially published yet.

Please, follow
us on social media

CONTACT Us

33B, Shota Rustaveli str., Kyiv, 01033, Ukraine

+380 (95) 692 26 08

daria.abulova@jerelo.eu

Mon - Sat | 9am - 8pm

© 2020 Jerelo, LLC. | All Rights Reserved

SUBSCRIBE