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Health Care

03/ 11/ 2015

On the 30th of October 2015 the Order of the Ministry of Health of Ukraine No.460dated 23 July 2015 was published. It finally cancelled the procedure of medicines’ re-registration that all medicines were to pass through every 5 years.

Since 2000s the Association’s Health Care Committee experts had worked on the approximation of the Ukrainian medicines’ registration (re-registration) procedures to those of the EU.

In this context, one of the most important issues was to cancel the current re-registration mechanism, for an every single registered medicine in Ukraine was subject to the re-registration of every five years in order to extend its further circulation in the pharmaceutical market. Such a practice wasn’t in compliance with the standards established in the EU, shape or form. In addition, a complexity of the procedure and a frequent failure to adhere to its legislative terms often caused unavailability of one medicine or another for the patients. In its turn, it led to the treatment interruptions. The Association was persistent in bringing attention of all state authorities’ officials to the necessity of solving this issue of utmost importance.

Eventually, the final step was performed. Starting from now the procedure of medicines’ re-registration meets European standards, namely: every medical drug is now entitled to pass through the re-registration procedure to get an unlimited registration certificate.

This step is also significant in the context of further deregulation in the pharmaceutical sector declared in Ukraine and is intended to simplify activities of both the domestic and foreign pharmaceutical companies.

We welcome these amendments and acknowledge those member companies of the Association’s Health Care Committee which contributed to their sooner implementation.

We do hope that this step, long expected by the pharmaceutical community, will be what is required via its correct implementation in practice and will serve for the improvement of medicines’ accessibility for the Ukrainian patients.

Legal background:

On the 20th of October 2014 the Verkhovna Rada of Ukraine adopted the а Law of Ukraine «On Amending the Law of Ukraine “On Medicines” regarding the circulation and the state quality control of medicines imported to the customs territory of Ukraine» (the Law No.1707-II), which cancelled the existing medicines’ re-registration procedure of every 5 years.

However, pursuant to the Law No.1707- VII, it was also indispensable to amend the following legal acts: the Resolution of the Cabinet of Ministers of Ukraine (CMU) No.376 dated 26 May 2005 and the MOH Order No. 426 dated 26 August 2005.

The amendments to the CMU Resolution No. 376 were adopted as far back as the 18th of March 2015 (CMU Resolution No.125).

The amendments to the MOH Order No.426 were adopted on 23 July 2015 (MOH Order No.460) and came into force on 30th October 2015.

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