On 04.09.2015 the Ministry of Health published on its official website for public consideration the Draft of the Ministry of Health of Ukraine Decree «On Amendments Introduction into Rules of Procedure for the State Register of Medical Products and Devices».
The Draft proposes to leave in the State Register of Medical Products and Devices until 30.06.2020 those medical products that were registered before 30.06.2015.
Please note that starting from 01.07.2015 the handling and/or exploitation of medical products is allowed only after the procedure of compliance verification with technical regulations regarding the medical products approved by Cabinet of Ministers Decrees № 753, 754, 755 from 02.10.2013. As a result the state registration of medical products has been cancelled.
At the same time, in view of the relief of business adaptation by 01.07.2016 to the new requirements with regard to the provisions of indicated regulations it is allowed to handle and/or exploit the medical products registered by the state and included into the State Register of Medical Products, and allowed for usage in the territory of Ukraine without the verification procedure of compliance and marking with the national conformity mark.
In accordance with the information indicated in the Draft summary, the adoption of the Draft Law shall facilitate the consumers awareness of the medical products being registered by the state and shall provide for their circulation without the compliance verification procedure. Moreover, the adoption of this Draft shall provide for gradual transfer from state registration procedure to compliance verification and marking with the national conformity mark.
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On 25 September, a webinar was held on the topic: ‘180 days of new drug price regulation. Results, prospects and practical advice.’ The event was organized by LA Law Firm in partnership with Proxima Research International.
