Drug – any substance or combination of substances (one or more APIs and excipients), that has properties and is intended for the treatment or prevention of humans’ diseases, any substance or combination of substances (one or more APIs and excipients), which can be designed for pregnancy prevention, restoring, correcting or modifying physiological functions of human through pharmacological, immunological or metabolic action, or to establish a medical diagnosis.
State registration of medicinal products (state marketing authorization) – procedure that is performed according to requirements of current legislation and Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products, which are Submitted for State Registration (Re-Registration) (order of MOH of Ukraine №426 from 26.08.2005) in order to approve medical use of a medicinal product.
Certificate of registration for medicinal product is valid for 5 years. To prolong registration for the next 5 years product should be re-registered (hereinafter – renewed).
Change in the registration dossier – a replacement part information, such as changing the design of the packaging and labeling, change the text-sheet insert or instructions for medical use, change the Applicant (sales registration certificate), a change in the description of the process of production, etc.