Ukraine Is Implementing the Best European Regulatory Practices for Pharmaceutical Industry – Minister Liashko
Revised Law of Ukraine on Pharmaceutical Drugs is intended to harmonize the Ukrainian legislation governing the legal relations in pharmaceutical industry with the European Union’s regulations.
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This is what Viktor Liashko, the Healthcare Minister of Ukraine, said in response to signing of the new draft bill on Pharmaceutical Drugs by the President of Ukraine.
"Comprehensive revision of legislative framework creates opportunities for both the regulatory system and the business to implement novel European regulatory practices, update and harmonize the market rules. This will contribute to the improved availability of medicines for Ukrainians in the entire world and to the better protection of their consumer rights”, the Minister said.
Liashko explained that since Ukraine is getting ready to join the European Union, the revision of regulatory provisions applicable to the country’s pharmaceutical industry is “of utmost importance”.
" Revised Law of Ukraine on Pharmaceutical Drugs implements the best European regulatory practices for pharmaceutical industry”, he noted.
The revised law determines:
- Conditions for creation, pharmaceutical development, pre-clinical studies, clinical trials (studies) and state registration of pharmaceutical drugs;
- Conditions for manufacturing, pharmacy preparation (production), prescription, use, import, wholesale and retail sale, remote sale, quality control and pharmacological vigilance of pharmaceutical drugs;
- Rights and obligations of legal entities and private individuals, as well as the powers of national regulatory agencies and officials in pharmaceutical field;
- Creation of conditions for pharmaceutical industry development, promoting positive investment climate, overcoming of technical barriers in the international pharmaceutical trade.
The law also regulates operation of online pharmacies, since it defines the rules for online medicine sale and supports exterritorial delivery.
The Ministry of Healthcare stresses that the new law will improve protection of consumer health, rights and interests. Moreover, the new law would also contribute to the lower level of corruption on the pharmaceutical market.
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