The Cabinet of Ministers has simplified the procedure for registering medicines: what will change
20 August 2024 04:17
The Cabinet of Ministers of Ukraine has approved a draft law that simplifies the registration procedure for medicines procured by the State Enterprise “Medical Procurement of Ukraine” (MPU). Relevant amendments will be made to the Law of Ukraine “On Medicines”. This was reported by "Komersant Ukrainian" with reference to the Ministry of Health of Ukraine.
The Ministry of Health noted that this draft law will expand patients’ access to new medicines and vaccines procured with public funds.
“In particular, it is about the registration of drugs 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),” the Ministry of Health explained.
The ministry added that this innovation will allow suppliers to register medicines for supply to the Ministry of Health faster – in just one month, compared to the usual procedure, which takes up to seven months.
Currently, the Law on Medicinal Products 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.
For registered medicines, the applicant is issued a certificate indicating the validity period during which the drug is allowed to be used in Ukraine.
Such a drug may be used in Ukraine for 5 years from the date of its state registration. After this period, its further use is possible subject to re-registration.
