Azerbaijan

v. 19 – Q3 2021

Market Executive Summary
  • 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 1 July 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
  • 13 July 2007: Order No. 108 “Rules for state registration and maintenance of the register of medicines”
  • 10 July, 2018: Resolution of the Cabinet of Ministers of the Republic of Azerbaijan No. 287 “Rules for the examination of biologically active food additives.”
  • 25 Dec, 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
  • 1 July 2020: the accelerated registration procedure has been introduced.

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