A comparative analysis of legislative and regulatory requirements for community pharmacies in five Balkan countries

A comparative analysis of legislative and regulatory requirements for community pharmacies in five Balkan countries

Poster

Nelina Hadzhieva1, Radiana Staynova2, Shazie Hasanova, Nikola Humchev1, Daniela Grekova-Kafalova2
1Faculty of Pharmacy, Medical University of Plovdiv, Bulgaria
2Department of Pharmaceutical Sciences, Faculty of Pharmacy, Medical University of Plovdiv, Bulgaria

Aim: To outline the similarities and differences in the legal and regulatory framework for community pharmacies in five Balkan countries – Bulgaria, Greece, Romania, The Republic of North Macedonia, and Turkey. Materials and methods: For the purpose of the study, a comparison between the legal documents on community pharmacies in the five Balkan countries has been made. The main focus was requirements on pharmacy licence, pharmacy ownership, premises, demographic restrictions, geographical distribution, and restrictions on horizontal and vertical integration. Results: The pharmacy licence may be facility-based or associated with a specific responsible pharmacist. In Romania and Turkey, the minimum area of the community pharmacy is 55 m2. In Bulgaria, the requirement is 30 m2 for a pharmacy without drug compounding and with one workplace. Demographic restrictions are most often determined on the basis of the number of inhabitants in the settlement. In Bucharest restriction is one pharmacy per 3000 inhabitants, while in other cities – one pharmacy per 4000 inhabitants. In Turkey, the minimum number of inhabitants per new community pharmacy is 3500. The minimum distance between new and existing pharmacy varies from 100 m in the Republic of North Macedonia to 250 m in Turkey and Greece. In Bulgaria, no more than four pharmacies can be owned by the same entity, while in Turkey, multiple ownership is forbidden. Discussion: Despite the above-mentioned legal and regulatory differences between these five Balkan countries, most of the requirements for opening and operating a community pharmacy are similar. This may be explained by the fact that they are all located in the neighboring Balkan Peninsula.
Keywords: Balkan Peninsula, pharmaceutical legislation, demographic restrictions