The population of Azerbaijan is about 10 million people. The pharmaceutical market is one of the fastest-growing sectors of economic activity, but it almost entirely depends on imports. The country’s regulatory system is actively developing.
The state language is Azerbaijani. About 40% of the population speaks Russian, and Turkish is also widely spoken.
Import and sale of medicinal products are allowed only after state registration. Any company, resident or non-resident of Azerbaijan, may act as a registration applicant; the establishment of a representative office or a local company is not required. The pharmacovigilance system is actively developing. Import of medicinal products, wholesale and retail pharmaceutical trading are subject to mandatory licensing.
To import medical devices and medical equipment, a letter of authorization and a hygienic certificate are required. State registration of medical devices is not carried out in Azerbaijan.
Cosmetic products, special food products (baby food, sports nutrition, medical nutrition) are delivered based on the hygienic conclusion.
Ministry of Health of The Republic of Azerbaijan
The central executive authority in healthcare
Web site: http://www.sehiyye.gov.az/
Analytical Expertise Center (AEC) of the Ministry of Health
Expert evaluation of medicinal product registration documents, pharmacovigilance
Web site: http://www.pharma.az
Republican Center of Hygiene and Epidemiology of Azerbaijan Republic
Expert evaluation and analysis of the quality of medical devices, cosmetics and food products
Web site: no website.
The main legislative acts:
- Law of the Republic of Azerbaijan dated December 22, 2006 “On Medicinal Products”;
- Order No. 108 dated July 13, 2007, “Rules for State Registration and Maintenance of the Register of Medicinal Products”;
- Decree of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019 No. 502 “Procedure for the examination of medicines”;
- Decree of the Cabinet of Ministers of the Republic of Azerbaijan dated July 10, 2018 No. 287 “Rules for the examination of biologically active food additives”.
Cratia provides professional services on state registration of healthcare products in Ukraine. We have a deep knowledge of the national legislation, significant experience, and necessary resources. We offer:
- registration of medicinal products in Azerbaijan;
- creation and maintenance of a pharmacovigilance system in Azerbaijan;
- certification of medical devices in Azerbaijan;
- certification of special food products in Azerbaijan;
- certification of cosmetics in Azerbaijan.