Ukraine. Legislation in pharmaceutical field
The importance of the pharmaceutical market for the economy of Ukraine as well as constitutional obligation of the state to create conditions for effective and accessible for all citizens healthcare system explain the constant close control of state regulatory authorities.
The legal regulation of healthcare in Ukraine is defined by a large number of legal acts and their quick changes; therefore a reliable legal partner is highly important and necessary on all stages of business conduction in Ukraine.
The legal regulation of healthcare in Ukraine is defined by a large number of legal acts and their quick changes; therefore a reliable legal partner is highly important and necessary on all stages of business conduction in Ukraine.
Legislation
Business in pharmaceutical field in Ukraine is regulated by a number of legal acts basic provisions of which are directed at supply of safe, quality and effective drugs to the population. The fundamental legal act in the pharmaceutical legislation of Ukraine is the Law of Ukraine «On Medicinal Products» dd. 04.04.1996 #123/96-VR which regulates legal relations connected to creation, registration, manufacturing, quality control and sale of medicinal products (hereinafter – medicinal products or drugs), determines rights and obligations of companies, institutions, organization and citizens as well as of state authorities and their officials in this sphere.
State administration
The Parliament of Ukraine determines state policy and regulates on legislative level the relations in the sphere of creation, manufacturing, quality control and sale of drugs.
The Cabinet of Ministers of Ukraine (hereinafter – the CMU) implements the state policy as to creation, manufacturing, quality control and sale of drugs through a system of state executive authorities, ensures development and implementation of respective nationwide and other programs within limits of their powers, ensures control over adherence to the legislation on drugs.
The Ministry of Healthcare of Ukraine (hereinafter – the MHC of Ukraine), the State Pharmacological Centre of the MHC of Ukraine (hereinafter – the State Pharmacological Centre or the Centre), the State Inspectorate for Quality Control of Drugs of the MHC of Ukraine (hereinafter – the State Drugs Inspectorate) and other specially empowered state authorities are responsible for administration of creation, manufacturing, quality control and sale of drugs.
Business in pharmaceutical field in Ukraine is regulated by a number of legal acts basic provisions of which are directed at supply of safe, quality and effective drugs to the population. The fundamental legal act in the pharmaceutical legislation of Ukraine is the Law of Ukraine «On Medicinal Products» dd. 04.04.1996 #123/96-VR which regulates legal relations connected to creation, registration, manufacturing, quality control and sale of medicinal products (hereinafter – medicinal products or drugs), determines rights and obligations of companies, institutions, organization and citizens as well as of state authorities and their officials in this sphere.
State administration
The Parliament of Ukraine determines state policy and regulates on legislative level the relations in the sphere of creation, manufacturing, quality control and sale of drugs.
The Cabinet of Ministers of Ukraine (hereinafter – the CMU) implements the state policy as to creation, manufacturing, quality control and sale of drugs through a system of state executive authorities, ensures development and implementation of respective nationwide and other programs within limits of their powers, ensures control over adherence to the legislation on drugs.
The Ministry of Healthcare of Ukraine (hereinafter – the MHC of Ukraine), the State Pharmacological Centre of the MHC of Ukraine (hereinafter – the State Pharmacological Centre or the Centre), the State Inspectorate for Quality Control of Drugs of the MHC of Ukraine (hereinafter – the State Drugs Inspectorate) and other specially empowered state authorities are responsible for administration of creation, manufacturing, quality control and sale of drugs.
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