Proposed Procedures for Registration Materials Revision for Medicinal Products Registration under Simplified Procedure

On 16.09.2016, the Ministry of Health published on its web-site for public consideration Draft Order of the Ministry of Health «On Approval of Revision Procedures for Medicinal Products’ Registration Materials submitted for Sate Registration (Re-registration), and Materials on Amendment of Registration Materials throughout the Validity Period of Registration Certificate for Medicinal Products Registered by Competent Authorities of the USA, Switzerland, Japan, Australia, Canada, and Medicinal Products Registered by Competent Authority of the European Union under Centralized Procedure».

The Draft Order was adopted aimed at further implementation of legislative changes regarding the extension of medicinal products’ list subject to simplified registration procedure, approved in article 9 of the Law of Ukraine «On Medicinal Products» and Procedures for Registration of Medicinal Products approved by the CMU Resolution № 376 dated 26.05.2005.

The Draft Order does not envisage the expert examination of registration dossier, as the fact is taken into consideration that the specialized expertise is conducted by registration authorities of the countries with strict regulatory requirements (the USA, Switzerland, Japan, Australia, Canada, the EU – under centralized registration procedure). The products are registered based on the submitted application and the following documents:

• Materials on the methods of quality control of medicinal product;
• Registration dossier materials provided by the regulatory authority of foreign state that registered the product taking into consideration all changes made after its registration;
• Product package samples, labeling texts of primary and secondary (if available) packages, and on the use of medicinal product in compliance with the requirements of the Procedures for Medicinal Products’ Registration Materials submitted for Sate Registration (Re-registration), and Materials on Amendment of Registration Materials throughout the Validity Period of Registration Certificate, approved by the MOH Order № 426 dated 26.08.2005;
• Certified copy of the document confirming the compliance of manufacturing conditions of the products submitted for registration with the requirement to manufacturing of medicinal products in Ukraine issued by the State Administration of Ukraine on Medicinal Products and Drugs Control, or written obligation of the manufacturer, responsible for the batch manufacturing, to produce the corresponding medicinal product for delivery to Ukraine at the same manufacturing facilities used for medicinal products manufacture for the USA, Switzerland, Japan, Australia, Canada, or the EU-member countries;
• Patients information leaflet developed in line with Ukrainian requirements;
• Documents confirming the payment of registration fees.