Policy Progress: Ministry of Health Published Its Draft Order Amending the Guidelines on Pharmacovigilance

On March 5, the Ministry of Health of Ukraine published its Draft Order “On Amending the Standard “Guidelines. Medicines. Good Pharmacovigilance Practices”.

Chamber Healthcare Committee experts in close cooperation with the State Expert Center in the framework of the Working Group worked on amending the Guidelines on Pharmacovigilance to harmonize it with the provisions of the relevant EU EMA Directive/213497/2017 Guideline on good pharmacovigilance practices, taking into account the requirements of the current legislation of Ukraine.

We hope that the proposed Draft Order will be approved by the Ministry of Health of Ukraine shortly.