Ukraine is moving to a common terminology and regulation of pharmaceutical growling with the European Union. This became possible thanks to the adoption of the updated law “On Medicines”, already signed by the President.
This was stated by the Minister of Health of Ukraine Viktor Lyashko, the press service of the Ministry of Health reports.
“Preparations for Ukraine’s accession to the European Union continue, therefore, the work on legal acts regulating the pharmaceutical industry of Ukraine is extremely relevant”, the minister explained.
Lyashko explained that the law harmonizes Ukrainian legislation regulating legal relations in the field of medicines with the EU regulations.
The document, in particular, defines:
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conditions for the creation, pharmaceutical development, preclinical studies, clinical trials, state registration of medicines;
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conditions of production, manufacture in a pharmacy, appointment and use;
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import, wholesale and retail trade, distance trade;
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quality control, implementation of pharmacovigilance of medicines;
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the rights and obligations of legal entities and individuals, as well as the powers of state authorities and officials in the field;
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creating conditions for the development of the pharmaceutical industry, creating a favorable investment climate, overcoming technical barriers in the international trade in medicines.
“A comprehensive update of the legislative framework is an opportunity for both the regulatory system and business to introduce new European-style work practices, update and unify market rules,” — Lyashko said.
He also stated that the new law will help improve the availability of medicine for Ukrainians around the world, and will also better protect their rights as consumers.
Source: Fakty
