The Verkhovna Rada adopted the law, which shortens the
period of registration of medicines to 10 days and provides for a simplified
procedure for medicines that are already registered in the EU, the U.S.,
Switzerland, Australia, and Canada.
Draft law No.4484
"On Amendments to Art. 9 of the Law ‘On Medicines’(with respect to the
state registration (re-registration) of medicinal products)" was supported
as a basis and in general by 239 deputies with 226 votes required for the bill
to pass.
Chairman of the
Parliamentary Committee on Healthcare Olha Bohomolets said that this bill would
eliminate the monopoly of the pharmaceutical companies on the Ukrainian market
of medicines and facilitate the entry to the Ukrainian market of medicines
already registered in the developed countries. "It allows us, according to
the model of the European Community, to bring into the territory of Ukraine
those medicines that Ukrainians today buy in Hungary, Slovakia, and Slovenia,
those that are much cheaper than those available in Ukraine," said
Bogomolets.
As noted in the
explanatory memorandum, the term of decision-making by the Ministry of Health
on drug registration is reduced to 10 working days [previously, it was a
month]. It is also envisaged that the state registration of a medicinal product
containing the active substance, which has already been registered by the
competent authorities of the United States, Switzerland, Australia, Canada or
the European Union, will be carried out under the simplified procedure.
As UNIAN reported
earlier, the Cabinet of Ministers on April 20 adopted a number of decisions on
the drug market deregulation with the aim of filling the market and
establishing competitive prices for medicines in Ukraine.
No comments:
Post a Comment