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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