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The introduction of assessment of non-drug medical technologies has been postponed

On November 16, the Resolution of the Cabinet of Ministers of Ukraine of November 10, 2021, № 1172 came into force, which amended the Resolution of the Cabinet of Ministers of Ukraine of December 23, 2020, № 1300 “On Approval of the Procedure for State Assessment of Medical Technologies”.

Thus, the changes postpone the deadline for the introduction of the state assessment of medical technologies (HTA), which are not medicines, from January 1, 2022, to January 1, 2023. Until this date, the deadline provided by the Ministry of Health for:

  • creation of a state unitary commercial enterprise, which will be entrusted with the functions of conducting state HTA;
  • development and approval of guidelines for state HTA, which are not medicines.

Also, the Procedure for state HTA, approved by Resolution № 1300, is supplemented by a new provision, according to which the Ministry of Health is obliged to approve the Procedure for inclusion (exclusion) of medicinal products in the National List of Essential Medicines and/or nomenclatures of purchased medicinal products. at the expense of the state budget for the implementation of programs and implementation of centralized health care measures, with the use of state HTA.

In addition, the amendments provide for the Ministry of Health to be able to extend the state OMT under the abbreviated procedure for 10 calendar days required for the Ministry of Health to respond to a reasoned request of the authorized body for state assessment of medical technologies (hereinafter – the authorized body).

We will remind, according to the resolution № 1300 the state HTA under the shortened procedure provides the comparative analysis of efficiency (effectiveness), safety and influence on the budget of medical technology on the basis of open information and lasts no more than 30 calendar days from the date of receipt by the authorized body. Ministry of Health.

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