Procedure for State Registration

Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products which are Submitted for State Registration (Re-Registration) and Expert Evaluation of Materials about Introduction of Changes to the Registration Documents during the Validity Period of Registration Certificate.

Registration is a requirement for the importation of medical products in to Ukraine.

The Public Enterprise State Expert Centerof the Ministry of Health of Ukraine is a specialized expert institution authorized by the Ministry of Health of Ukraine (hereinafter MoH) to register and control circulation of medicinal products as per Law of Ukraine On Medicines

Medicinal products shall be allowed for use in Ukraine after their state registration, except for cases specified by this Law

LAW OF UKRAINE ON MEDICINES 124/96- of 04.04.96.

This Law shall govern the legal relations connected with the development, registration, manufacturing, quality control, and sale of medicinal products, shall specify the rights and obligations of enterprises, institutions, organisations, and citizens, and also the competence of the state executive authorities and officials in this sphere.

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).

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