On October 20th 2014, the Verkhovna Rada of Ukraine adopted the Law of Ukraine “On Amending the Law of Ukraine “On Medicines” as regards the circulation and the state quality control of medicines imported to the customs territory of Ukraine»” (the Law), which anticipates that after the first term of a medicine’s circulation in Ukraine is expired, its further circulation will be permitted should it pass the renewal procedure, with the next term unlimited.
Prerequisites: Over a number of years the Association’s Health Care Committee experts advocated the necessity to approximate Ukrainian renewal procedures to those of the EU. In this context, one of the most important issues was to cancel the current renewal procedure, which meant that every registered medicine was subject to pass through it every five years to be entitled to further circulation. Such a practice didn’t comply with the provisions established in the EU. In addition, the complexity of the procedure and frequent impossibility to adhere to the legislative terms for passing it caused the unavailability of one or another medicine on the market and, in its turn, it entailed treatment interruption. The Association continuously brought all levels of the state authorities’ attention to the necessity of solving this issue of utmost importance.
We are delighted to emphasize that the Government of Ukraine took an intelligent attitude to the problem and in conjunction with the Association’s experts, they developed the relevant Draft Law No.4459a, which was registered by the Verkhovna Rada on August 11th 2014.
On October 20th 2014, the Ukrainian Parliament supported the Government’s initiative and passed the bill unamended.
Apart from the above-mentioned solved problem, the adopted Law also solves another problematic issue that was one of the Association’s top priorities over a protracted period of time. In particular, the circulation of medicines put on the market during their effective registration certificate term in Ukraine will be possible until their shelf life period expiry marked on the packages. We are convinced that this step will also improve the accessibility to medicines for patients in Ukraine.
We acknowledge the contribution of all the members of the Association’s Health Care Committee and state authority representatives whose positive attitude and practical efforts were visible and led to the success.
Simultaneously, we do hope to provide evidence at the soonest opportunity of the benefits the adopted provisions have brought to the pharmaceutical market and Ukraine’s people. As there can be no further delays in the implementation of all sub-legislative acts necessary for the effective enactment of the Law’s provisions, this evidence should be provided in the nearest future.