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Health Care

07/ 04/ 2016

On 23 March 2016 the Government of Ukraine adopted the Resolution No. 240 which removes a legislative barrier and extends the transition period for the registered medical devices until 1 July 2017.

Continuously, manufacturers were faced with a legislative barrier in the medical devices area. This prevented them from passing conformity evaluation procedures, manufacturing medical devices and packaging them with a national conformity sign if the medical devices possess valid registration certificates. Consequently, certain categories of medical devices were at threat: international manufacturers would not be able to import them on normal terms and the population of Ukraine would be deprived of lifesaving medical products. This market crisis could start on 1 July 2016 and last from 3 to 6 months. The fact that over 80% of the market share of medical devices was made up of products manufactured abroad added a special tension to the overall situation.

The Association appealed on many occasions to the executive authorities including the Ministry of Health of Ukraine (further referred to as the MOH) and the Ministry of Economic Development and Trade of Ukraine explaining that this issue needed to be settled as soon as possible and proposing different solutions.

On 21 March 2016 the Association published a press release and sent out an open letter to the Prime Minister of Ukraine calling for urgent actions to prevent a collapse in the medical devices market.

The adopted CMU Resolution solved the long-lasting problems. Firstly, the companies currently supplying medical devices to Ukraine will not be faced with restricted conditions anymore. Their products can be stamped with the national conformity sign and the newly-marked packages can be imported.

Secondly, the transition period has been extended till 1 July 2017. Thus, there now is a sufficient time period to allow companies to fulfill new legislative requirements and start supplies to Ukraine right after their registration certificates for medical devices expire.

We welcome the adoption of the CMU Resolution. Eventually, the terms for medical company business planning have been settled in favour of uninterruptible supplying necessary medical devices to the Ukrainian people.

The Association is thankful to the management of the MOH and CMU for understanding the kernel of the problem and taking the decision which was long-awaited by market operators. We expect prompt official publication of the CMU Resolution.

The Association is looking forward to the next steps that will bring a legislative solution of a problem dealing directly with further success of the health care reform and improvement of medical services for the population. Duplication of procedures should be eliminated, allowing for recognition of EU certificates for medical devices in Ukraine. Currently, the situation prevents the introduction of state-of-the-art medical technologies into Ukraine.

Legal background:

On 1 July 2014 the CMU Resolution «On amending certain resolutions of the Cabinet of Ministers of Ukraine» No.181 dated 23 May2014 (the CMU Resolution No.181) was made effective. The CMU Resolution No.181 adopted a transition period for the circulation of medical devices registered before 30 June 2015. Also, the CMU Resolution stipulated that the medical devices with valid registration certificates were not subject to Technical Regulations on Medical Devices adopted by the CMU Resolutions No.753, 753, 755 dated 2 October 2013 (Technical Regulations). It constituted a legislative collision in the medical devices’ area.

On 1 July 2015 the Technical Regulations were made mandatory for application. Simultaneously, the CMU Resolution “On approving the Order of State Registration of Medical Equipment and Medical Devices” No.1497 dated 9 November 2004 became null and void.

On 22 September 2015 Draft CMU Resolution was web-placed in MOH’s web for public discussion and then supported by the Ministry of Finance of Ukraine, the Ministry of Economic Development and Trade of Ukraine and, it also obtained a positive conclusion as a result of legal expertise by the Ministry of Justice of Ukraine, along with comments as regards the legal techniques which were taken into account in the adopted CMU Resolution.

On 23 March 2016 there was adopted the CMU Resolution No.240 which, in particular, adopted items 21 of the Technical Regulations with new wordings and added to the plan of actions on application of Technical Regulations extending the terms of actions’ implementation until 1 July 2017 as regards the “mandatory application of the Technical Regulation” for medical devices possessing registration certificates, included into the State Register of Medical Equipment and Medical Devices and eligible for application at the territory of Ukraine, with their registration certificate validity period unlimited or expired after 1 July 2017.

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