The Verkhovna Rada of Ukraine cut back on the length of registration of medicinal products up to 10 days and simplified the process of medicines for drugs that have already had the drug registration status in the United States, European Union, Canada, Switzerland and Australia.
Changes in the registration procedure are legislated under the bill №4448 «On Amendments to Article 9 of the Law of Ukraine “On Medicines” (with respect to the state registration (re-registration) of medicinal products).” 239 deputies (at a minimum – 226 votes) voted for the adoption of the bill.
Olga Bogomolets, Head of the Verkhovna Rada Committee on Health, stressed that the bill was created to remove the monopoly of companies in the Ukrainian pharmaceutical market and to facilitate the access of Ukrainians to high-quality medicines, which are available to residents of developed countries.
“It allows us after a model of the European Community to bring into the territory of Ukraine such drugs that Ukrainians go to buy to Hungary, Slovakia, Slovenia today, which are much cheaper than those presented in Ukraine”
In the explanatory note to the bill, a proposal to reduce the period allocated to the decision on registration of medicines from one month to 10 days by the Ministry of Health is stated. It also indicates that a drug with the active ingredient, which has been registered in EU countries, the United States, Canada, Switzerland and Austria will be registered under the simplified procedure in Ukraine.
In addition, it was informed, that in a panel session on April 20, the Cabinet took several decisions aimed at creating competitive drug prices and filling the pharmaceutical market of Ukraine, in particular, the government passed a decree on deregulation of the medicines market.
Also the proposal to reduce the time of drugs expertise up to 20 days, to revise the limits on pharmaceuticals contracts that are under the control of transfer pricing, to exclude the possibility of the organization of parallel imports of medicines in Ukraine, as well as to revise the packaging requirements with the ability to use the original packaging – in the manufacturer’s language has been received. However, on May 10, the draft law was withdrawn and the bill discussed yesterday replaced it.
По матеріалу: УНІАН