Health Care

29/ 11/ 2019

Enough explanations on SI labelling for medical drugs and devices are received

European Business Association (EBA) is pleased to inform that two clarification letters long-awaited by the pharmaceutical business community are finally received, as follows: one is from the Ministry of Development of Economy, Trade and Agriculture of Ukraine (MinEco) dated 12 November 2019 and another is from the Ministry of Health of Ukraine (MOH) dated 19 November 2019, as to some rules of SI labelling for medical drugs and medical devices.

As well-known, SI labelling of medical drugs and devices was postponed in the end of 2018 for 2 (two) calendar years due to the lack of common understanding as to the use of SI labelling, in particular, for medical drugs sphere for both business community and state authorities and incompatibility of the MinEco Order 914 dated 4th August 2015 (further referred to as Order 914) with other sub-legislative acts. It resulted in no objective conditions for the timely application of rules by businesses.

Now two separate explanations received from MinEco and MOH contain necessary answers to those questions which the business companies have had before. Therefore, the companies will be able now to use them to meet the rules of the Order 914.

We are grateful to the MinEco and MOH incumbents for their attitude of understanding towards business needs and facilitation of important clarifications that finally ensure availability of clear information for market players and create necessary conditions for the business community to use it in their work in order to meet the new rules.

The business community of the EBA Health Care Committee is hopeful that it will be possible in the future to avoid market tension that came true due to purely technical reasons, for there was a lack of timely and transparent rules to make the businesses work smoothly.


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