The Cabinet of Ministers made changes to the procedure for registration of medicinal products: what changes should we expect
It is planned to provide Ukrainians with wider access to new medicines and vaccines financed by the state budget.
The Cabinet of Ministers of Ukraine has approved a draft law that simplifies the procedure for the registration of medicinal products purchased by the SE “Medical Purchases of Ukraine” (MZU). Corresponding changes will be made to the Law of Ukraine “On Medicinal Products”. About this informs Ministry of Health of Ukraine.
The main goal of this draft law is to ensure wider access of patients to new medicines and vaccines purchased with public funds.
The innovation will allow suppliers to significantly speed up the process of registering drugs for the supply of MZU, reducing it to one month, as opposed to the usual procedure, which can take up to seven months.
In particular, the draft law provides for simplified registration for drugs that are included in the list of drugs and vaccines prequalified by the World Health Organization (WHO).
This also applies to drugs included in the database that can be purchased under the US President’s Emergency Plan for HIV/AIDS (PEPFAR).
The Ministry of Health noted that previously simplified registration was available for medicinal products registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada and the European Union under a centralized procedure. The new draft law adds to this list drugs registered in Great Britain, as well as in EU member states under a decentralized procedure.
Registered medicines will receive a certificate with a five-year validity period, during which they can be used in Ukraine. After the end of this term, they can be reapplied subject to re-registration.
Let us add that the pharmaceutical market of Ukraine shows significant growth in the first half of 2024, despite numerous challenges. As Yevhen Zayka, regional director of the pharmaceutical company Acino, noted, sales increased by 19% in monetary terms, although in natural terms the increase was only 3%.
In addition, pharmacy sales in Ukraine for January-May 2024 increased by 13.87% in monetary terms compared to the same period in 2023, reaching UAH 80.159 billion. At the same time, in natural terms, sales decreased by 4.2%, amounting to 491.363 million packages.
