Bulgaria's New Medicines Act

Bulgaria's new Human Medicines and Pharmacies Act sets strict rules for the import and export of pharmaceuticals, reports the Bulgarian Economic Review. Chapter Eight of the Act says that import and export licenses will only be issued to traders who hold a license for the manufacture or wholesale trade of drugs. Imports will be limited to medicines registered in bulgaria. Their price will be regulated by the state.

Only medicines registered in Bulgaria may be advertised, and the content must be approved beforehand by the state medicines control authority. Only over-the-counter products may be advertised in the mass media; other medicines may be advertised in specialist publications. Violations of these provisions are punishable by fines of 20,00-40,000 leva ($300-$600). The fine for a repeat offense is 40,000-60,000 leva ($600-$900).