Health Care

17/ 04/ 2019

The medical drugs’ advertising status regulation is changed

European Business Association is pleased to announce that the legislation gap related to the technical impossibility to change the medical drugs advertising status is filled in. Now the possibility of changing the status is established not only as a result of the medical drugs’ renewal procedure, but also the variations procedure.

Medical drug is a ‘live’ product. As a result of the confirmed changes to one or another “parameter” of a medical drug the appropriate changes are made to the registration materials (variations procedure). Such changes may directly affect the advertising status of a drug as in accordance with the defined Criteria [1]. Up to now there were no legal grounds to allow changes in the State Register of Drugs of Ukraine (Register) accordingly, as based on the extended or narrowed list of indications.

As a result of amendments to the Cabinet of Ministers of Ukraine Resolution №376 [2], the possibility of changing the medical drugs advertising status in the Register should be ensured just in the right time where there is a relevant evidence, which is confirmed by the State Expert Center recommendations followed by the  relevant decision of the Ministry of Health of Ukraine.

We express our gratitude to the Ministry of Health of Ukraine for the first step in solving the issue and are looking forward to its further implementation in practice.

[1] Ministry of Health of Ukraine Order №422 dated 6 June 2012

[2] Сabinet of Ministers of Ukraine Resolution №296 dated 27 March 2019

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