When registering a medicinal product, the applicant must specify the grounds for choosing the type of medicinal product to which the set of available registration documents must correspond.
The types of medicinal products and the requirements for the materials of the registration dossier are specified in Section III of the Procedure for the expert evaluation of materials on medicinal products (as amended by Order of the Ministry of Health No. 460).
Regulatory references: http://zakon5.rada.gov.ua/laws/show/z1210-15
