12 February 2025
roadmap
bulgaria
Pharmaceuticals: challenges in entering Bulgaria's wholesale medicinal market
The pharmaceutical market in Bulgaria is a dynamic and rapidly growing sector, driven by increasing healthcare demands and a robust regulatory framework. It features a competitive mix of local and international players, with a significant presence of generic and innovative medicinal products. The push for generic medicinal products has also led to a rise in previously limited patent-related cases and revocation proceedings. However, the wholesale market remains crucial for ensuring the availability and distribution of medicinal products throughout the country.
What should companies consider to successfully establish operations in Bulgaria?
The primary legislation governing this sector is the Act on Medicinal Products in Human Medicine, which sets forth the conditions and procedures for the authorisation, production, import and trade of medicinal products. The Ordinance on Drug Registration Requirements provides additional details on the documentation and compliance standards necessary for the market entry of medicinal products. A variety of regulatory frameworks outline the administrative procedures required before effectively placing a medicinal product on the market, including market authorisation, price regulation and price negotiation. The complexity of navigating the demands for wholesalers has posed a barrier for some foreign stakeholders, yet it has proven profitable for many others. Rising demand for healthcare services contributes to an attractive investment environment. The market's potential for further growth, driven by an aging population and increasing healthcare expenditure, presents lucrative opportunities for wholesalers.
authors: Alexandra Minioti, Hristo Hadzhiiliev, Elena Todorova
Alexandra
Minioti
Junior Associate
bulgaria