The Government has approved a draft law to simplify the registration procedure for medicines procured by the State Enterprise “Medical Procurement of Ukraine”. The amendments will be introduced into the Law of Ukraine “On Medicines”.
The main goal is to improve patient access to new medicines and vaccines that can be procured by the Ministry of Health at the expense of the state budget. In particular, it concerns the registration of medicines included in the list of medicines prequalified by the World Health Organization (WHO), vaccines and medicines included in the database of medicines that can be procured under the President’s Emergency Plan for AIDS Relief (PEPFAR).
Currently, the Law on Medicines provides for a simplified procedure for registration of medicinal products procured by an authorised procurement entity for medicinal products registered by the competent authority of the United States of America, the Swiss Confederation, Japan, Australia, Canada and used in the territory of these countries, or by the competent authority of the European Union under a centralised procedure and used in the territory of the EU member states.
The new draft law also provides for changes to this list. These include medicinal products registered in the UK and in EU member states under a decentralised procedure.
Currently, suppliers can register medicines for delivery to the State Enterprise “Medical Procurement of Ukraine” within one month, while the State Expert Centre of the Ministry of Health conducts an expert examination of materials during the full registration procedure within 7 months. For registered medicinal products, the applicant receives a certificate stating the period of validity during which the product may be used in Ukraine. Such a medicinal product may be used in Ukraine for 5 years from the date of its state registration. After this period, further use is possible subject to re-registration. (Government portal)