Ukraine is working on simplifying the entry of drug manufacturers into the EU market
In Ukraine, further integration of the pharmaceutical industry into the EU market and mutual recognition of GMP/GDP certificates were discussed.
The Committee on National Health, Medical Care, and Medical Insurance noted that over the past year, a number of steps have been taken to integrate the Ukrainian pharmaceutical sector into the European market. In particular, the Verkhovna Rada ratified the joint procurement agreement with the EU, and the European Parliament supported the inclusion of candidate countries, including Ukraine, in the European Act on Critical Medicines.
The adaptation of Ukrainian legislation to the requirements of the European Union is also ongoing. The Committee reminded that one of the key elements of this process was the law on medicines aimed at harmonizing drug circulation rules with European standards.
In addition, the Cabinet of Ministers approved the decision to create the Ukrainian Pharmaceutical Agency, which will perform the functions of an industry regulator. The next step is to hold an open competition for the position of its head.
During the forum "Regional Dialogues with Business on Eurointegration: Pharmaceutical Industry," participants discussed the economic significance of the pharmaceutical industry for Ukraine and further legislative changes needed to approach EU standards.
Special attention was paid to the issue of mutual recognition of GMP and GDP certificates. The Committee reported that after Ukraine's accession to the EU, such certificates will be recognized automatically. At the same time, consultations are already underway with certain European countries regarding the possibility of mutual recognition of documents at the national level.
It is expected that this may simplify the entry of Ukrainian manufacturers into European markets and reduce the number of additional regulatory procedures.
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