Clarifications on the use of SI labeling for medicines are received
European Business Association is glad to inform about the official publication of MOH clarification letter of November 17, 2020 regarding the application of the provisions of MinEco Order No. 914 of August 4, 2015, concerning SI labeling of medicines, coming into force on January 1, 2021.
As is commonly known, the apparent inconsistencies of MinEco Order No.914 with the provisions of industrial standard regulations in the field of drug circulation put under threat the timely and sustainable supply of high quality and safe medicines to Ukraine.
MOH clarification letter defines the procedure for manufacturers and importers of medicines who will import medicines into Ukraine after January 1, 2021 (the time when some provisions of MinEco Order No.914 come into force). The clarification letter contains the explanation of the rules for market entities on medicines manufactured before the new requirements came into force and also details the correlation of the provisions of MinEco Order No. 914 with the current legislation in the field of drug circulation.
The Association and the Healthcare Committee of the Association express their gratitude to the Deputy Minister of Health of Ukraine Ihor Ivashchenko for an effective dialogue with business community representatives and providing the necessary clarifications ensuring the absence of interference and the sustainable provision of high-quality, effective and safe medicines to Ukrainian patients.