Draft Bill Of Amendments To Law On Medicines – Healthcare

Law No. 208-IIIQ of the Republic of Azerbaijan, On
Medicines, of 22 December 2006, regulates handling and
circulation of medicines. The Law covers registration, expert
examination, and certification, licensing of production, wholesale,
and retail sale, export and import, advertisement, as well as
compensating damage from the use, of medicines.

Per the Law, the following are subject to the State
registration: (i) brand-name (original) medicines; (ii) generics;
(iii) new combinations of medicines; (iv) medicines under expired
State registrations; and (v) substances used in the manufacture of
medicines. The following medicines are not subject to registration:
(i) exhibition samples; (ii) prepared in pharmacies based on
prescriptions; (iii) imported for use in emergencies; (iv) intended
for research, preclinical studies, and clinical trials; (v)
imported as samples as well as substances used in manufacture; (vi)
imported by individuals for personal use in appropriate quantities;
(vii) recommended for use by the World Health Organization; (viii)
intended to treat rare diseases; and (ix) prescribed by
participating States for use by their athletes and personnel in
sport competitions.

The most recent draft bill of amendments to the Law passed the
first reading at the parliament, Milli Maclis, on 23 June. The
amendments modernize the Law by, for instance, aligning with the
tax laws the requirement for drugstores to be operated by
businesses.

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Originally published June 2023.

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