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Ukrainian drug registration regulations amended


Victor Yanukovych, the President of Ukraine,┬áhas ratified an amendment to Article 9 of the country’s Law on Medicines, which introduces a number of important changes to the regulations regarding the registration of originator and generic pharmaceutical products, and the associated data exclusivity regulations.

The new amendment to Ukraine’s Law on Medicines is presented as balancing the requirement to protect data exclusivity on the one hand, and to promote enhanced access to medicines for Ukrainians on the other, according to Brendan Melck, European Analyst at IHS Global Insight.

Although the original amendment to the Law is seen as giving too much away to innovative producers, the new amendment means that companies will be forced to consider entering the Ukrainian market earlier than they might have planned (if they had planned to enter it at all) in light of the fact that if they fail to do so within two years of their product first being registered, they will forfeit their right to data exclusivity in Ukraine.

This provision, as well as the “confirmation” of the legal status of compulsory licensing, is consistent with the agenda of increased access to medicines in Ukraine, and also with the government’s aim of increasing the proportion of medicines consumed in Ukraine that are produced in the country.

For innovative pharmaceutical companies, these are negative, if not entirely surprising, developments.

Ukraine remains an important market, due to its sheer size and potential, although it is set to remain a challenging one for the foreseeable future.

IHS Global Insight

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