Law of Ukraine

“On Medicinal Products”

Date of Entry into Force:
May 7, 1996

This Law shall govern the legal relations connected with the development, registration, manufacture, quality control, and sale of medicinal products.

Medicinal products may be developed by enterprises, institutions, organizations, and citizens.

This Law defines the procedure of state registration of medicinal products A decision to approve the state registration of medicine confers approval of the pharmacopeial monograph or the methods of quality control of the medicine, the approval of the technological requirements or the technology of manufacturing, and the medicinal product shall be given a registration number which shall be entered the State Register of the Medicinal Products of Ukraine.

The medicinal product may be used in Ukraine within the period of five years from the date of its state registration.

Manufacture of medicinal products shall be performed by natural persons or legal entities on the grounds of the special permission (license).

The wholesale purchase, and wholesale and retail sale of medicinal products in Ukraine shall be conducted by the enterprises, institutions, organizations, and citizens in accordance with the special permission (license).

Authority for the state quality control of medicinal products shall be granted to the State Inspection for Quality Control of Medicines of the Ministry of Health of Ukraine with directly subordinated thereto State Inspections for the Quality Control of Medicines in the Autonomous Republic of Crimea, oblasts and cities of Kyiv and Sevastopol.
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