ORDER of 04.01.2013 №3

Application for State Registration of Medicinal Product

Application for state registration (re-registration) of medicinal product

Application for State Registration (Re-Registration) of API or Active Substance
Application for state re-registration of medicinal product
Structure of registration dossier (format of common technical document – CTD)

The list of documents required for conducting expert evaluation of materials
of registration dossier for state registration of API or active substance

List of documents for conducting expert evaluation of materials for state re-registration of medicinal product
List of documents for conducting expert evaluation of materials for state re-registration of traditional medicinal products and medicinal products produced according to the approved specifications
Structure of Registration Dossier (in format of four parts)
Structure of instructions for medical use of medicinal product/medicinal product (medical immunobiological product)
Materials of registration dossier submitted for expert evaluation of changes made in registration materials during the validity period of the registration certificate
Application for Introduction of Changes to Registration Materials for Medical Product (including medical immunobiological product)
Changes to instructions for medical use of medicinal product/medicinal product (medical immunobiological product)
Structure of summary of product characteristics for medicinal product/medicinal product (medical immunobiological product)
Letter
List of excipients to be obligatory specified on package and information about effect of these substances depending on the route of administration and contents of excipients to be stated in instructions for medical use of medicinal product