What needs to be done for Ukrainian medicines to be freely exported to the EU
On 28 May, the European Commission announced a Twinning project call to find EU experts who will assist Ukraine in establishing a new national pharmaceutical regulatory authority.
For the first time in the healthcare sector, a Twinning project is being launched involving EU countries to support a European integration reform in the pharmaceutical field.
Read more about the reform and how the Twinning project will support its implementation in the column by Maryna Slobodnychenko, Deputy Minister of Health for European Integration: Visa-free regime for medicines" and a new regulator: how the pharmaceutical sector is moving towards the EU market.
Slobodnychenko emphasises that pharmaceutical reform is a key priority for Ukraine’s pharma sector.
According to her, two major directions or tasks currently define the European integration work in the pharmaceutical sphere:
First, extending the future "industrial visa-free regime" with the EU to pharmaceutical products. This refers to the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA).
As Slobodnychenko explains, this would mean that trade in medicines between Ukraine and the EU will follow EU single market rules, without the need for additional certification.
"Such an initiative was recently presented to the European Commission as part of accelerated integration efforts. This gives us a high chance of achieving a positive outcome even before EU accession," the official predicts.
She notes that achieving this "pharma visa-free" regime is neither simple nor quick: it requires a political decision from the EU and the implementation of EU standards by Ukraine.
This leads to the second key direction of current European integration work – the creation of a new regulator that will ensure reliable oversight of the quality and safety of medicines, as well as high standards for drug authorisation (registration) in Ukraine.
"The strength of the new regulator will lie in its financial sustainability. It will be funded not only by the state budget, but also through business contributions and fees. It will also be independent, as a separate central executive authority," writes the Deputy Minister.
She notes that active work on this new body has been ongoing for over a year.
The new regulator is expected to become operational on 1 January 2027.
According to Slobodnychenko, the aforementioned Twinning project will help Ukraine complete the development of this future regulator. The Twinning project will bring together experts from EU countries and Ukraine.
In fact, cooperation with EU experts is already underway. A support group has been formed, comprising representatives from the regulatory bodies of EU member states such as Poland, Sweden, Denmark, France and Croatia.
Interestingly, the organisational structure of Ukraine’s future regulator is based on the Swedish model.