The Government of Ukraine simplifies drug registration: what will change for patients and pharmacists

The Cabinet of Ministers of Ukraine adopted a new draft law that significantly simplifies the procedure for registering medicines purchased by the state enterprise "Medical Purchases of Ukraine" (MZU). The amendments to the Law of Ukraine "On Medicinal Products" are aimed at accelerating patients' access to the latest medicines and vaccines purchased with state funds.

As the Ministry of Health of Ukraine notes, the main goal of this draft law is to expand the access of Ukrainian patients to modern and effective medicines. The new procedure will allow providers to register drugs for supply to the MHI in just one month, much faster than the current procedure, which can take up to seven months.

One of the important innovations is simplified registration for medicines that are already included in the list of pre-qualified medicines by the World Health Organization (WHO). This also applies to vaccines and drugs included in the database that can be purchased under the US President's Emergency Plan for HIV/AIDS (PEPFAR).

Until now, simplified registration was possible only for drugs registered in the USA, Switzerland, Japan, Australia, Canada and the European Union under the centralized procedure. According to the new draft law, this list was expanded by adding to it 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, which allows their use on the territory of Ukraine. At the end of this period, the medicine can be re-registered for continued use.

The pharmaceutical market of Ukraine shows steady growth, despite the challenges the country is facing. In the first half of 2024, sales of medicinal products increased by 19% in monetary terms, although in natural terms the growth was only 3%. This was stated by the regional director of the pharmaceutical company Acino Yevhen Zayka.

In addition, sales in Ukrainian pharmacies for the period January-May 2024 increased by 13.87% in monetary terms, reaching 80.159 billion hryvnias. However, in real terms, sales fell by 4.2% to 491.363 million packages.

These changes are aimed at providing Ukrainians with affordable and high-quality medicines, which is especially important in the difficult situation in the country.