EBA Health Care Committee has translated the new Law on Medicines into English

20/ 02/ 2023

On July 28, 2022, the Verkhovna Rada of Ukraine adopted a new version of Law No. 2469-IX On Medicinal Products (hereinafter - Law No. 2469-IX). Representatives of the EBA Health Care Committee were actively involved in the development and improvement of the law for the second reading and supported its adoption. To continue its support, the EBA Health Care Committee organized the translation of Law No. 2469-IX into English. The finished English version was sent to the Committee on Public Health, Medical Assistance and Medical Insurance of the Verkhovna Rada of Ukraine, the Ministry of Health of Ukraine and other relevant government agencies and partners for use. The translation of Law No. 2469-IX is available at the link. The EBA Health Care Committee is convinced that Law No. 2469-IX is an important transitional stage on the way to Ukraines full membership in the European Union and the full implementation of EU legislation in Ukraine in the pharmaceutical sector. Given Ukraines active preparation for the start of negotiations on Ukraines accession to the EU, the need to assess Ukraines regulation for compliance with the provisions of the EU acquis communautaire, the obvious need to update and further adapt the provisions of pharmaceutical legislation, including those set out in Law No. 2469-IX, the EBA Health Care Committee believes that there is an urgent need to prepare and maintain up-to-date English versions of pharmaceutical regulations. At the same time, the EBA Health Care Committee experts identified some provisions of Law No. 2469-IX that require further legislative elaboration as they do not fully comply with EU regulations. The first is the issue of exclusivity of the registration dossier data – the provision does not meet the conditions set out in Directive 2001/83/EC. Also, it is the issue of parallel imports – the introduced mechanism is only similar to the parallel distribution in the EU, but it does not exist in the EU within only one country. Besides, the mechanism conflicts with the conditions necessary to combat counterfeiting for parallel imported medicines – the requirements for verification of medicines established by law do not apply to parallel imports. We hope that the English version of Law No. 2469-IX will be useful in further analysis and negotiations with international partners and in ensuring fundamental eurointegration activities, which should accelerate the movement towards EU membership. We are also convinced that the English version will be useful for pharmaceutical industry professionals in their work.

On July 28, 2022, the Verkhovna Rada of Ukraine adopted a new version of Law No. 2469-IX “On Medicinal Products” (hereinafter – Law No. 2469-IX). Representatives of the EBA Health Care Committee were actively involved in the development and improvement of the law for the second reading and supported its adoption. To continue its support, the EBA Health Care Committee organized the translation of Law No. 2469-IX into English. The finished English version was sent to the Committee on Public Health, Medical Assistance and Medical Insurance of the Verkhovna Rada of Ukraine, the Ministry of Health of Ukraine and other relevant government agencies and partners for use.

The translation of Law No. 2469-IX is available at the link.

The EBA Health Care Committee is convinced that Law No. 2469-IX is an important transitional stage on the way to Ukraine’s full membership in the European Union and the full implementation of EU legislation in Ukraine in the pharmaceutical sector.

Given Ukraine’s active preparation for the start of negotiations on Ukraine’s accession to the EU, the need to assess Ukraine’s regulation for compliance with the provisions of the EU acquis communautaire, the obvious need to update and further adapt the provisions of pharmaceutical legislation, including those set out in Law No. 2469-IX, the EBA Health Care Committee believes that there is an urgent need to prepare and maintain up-to-date English versions of pharmaceutical regulations.

At the same time, the EBA Health Care Committee experts identified some provisions of Law No. 2469-IX that require further legislative elaboration as they do not fully comply with EU regulations. The first is the issue of exclusivity of the registration dossier data – the provision does not meet the conditions set out in Directive 2001/83/EC. Also, it is the issue of parallel imports – the introduced mechanism is only similar to the parallel distribution in the EU, but it does not exist in the EU within only one country. Besides, the mechanism conflicts with the conditions necessary to combat counterfeiting for parallel imported medicines – the requirements for verification of medicines established by law do not apply to “parallel imports”.

We hope that the English version of Law No. 2469-IX will be useful in further analysis and negotiations with international partners and in ensuring fundamental eurointegration activities, which should accelerate the movement towards EU membership. We are also convinced that the English version will be useful for pharmaceutical industry professionals in their work.