Past discussions in 2016 suggested plans to move towards medicines traceability, suggested to be in line with GS1 standards with focus on market access.
Main Bill “On Drugs” is published in 2006 with smaller modifications until 2018
Changes to the registration procedure for medicinal products have come into force since July 1, 2020, and the accelerated registration procedure has been introduced.
Also, the rules for conducting pharmacovigilance have come into force, obliging the marketing authorization holders to establish and maintain a pharmacovigilance system in Azerbaijan, appoint a local contact person and perform other activities.
Key Dates
July 1, 2020: the accelerated registration procedure has been introduced.
December 25, 2019: Resolution of the Cabinet of Ministers of the Republic of Azerbaijan No. 502 “Procedure for the examination of medicines”. Resolution came into force from 1 July 2020
June 2019: list of products, including medicines, subject to mandatory labelling was established
July 10, 2018: Resolution of the Cabinet of Ministers of the Republic of Azerbaijan No. 287 “Rules for the examination of biologically active food additives.”
July 13, 2007: Order No. 108 “Rules for state registration and maintenance of the register of medicines”
