Department of Pharmacoeconomic and Phrma Management, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
One of the most important duties of government in public health sector is to provide secured sources for medicines supply. There are some regulations for domestic pharmaceutical industry. In addition, there is a discipline for importing medicine to be ensured about their claimed characteristics. In medicines registration process, MOH (FDO in Iran) assess ‘safety’, ‘quality’ and ‘efficacy’ of medicines and they will be registered if they’ll be able to pass the assessment. Some countries establish ‘cost- effectiveness’ as fourth hurdle in registration process of medicines. It means that at first authorities must be ensured about safety, quality and efficacy of medicines.
In Iran, there are two main importing forms of medicines. One is by agents, who registered the medicines and have responsibility for them. Agents should trace medicines from buying stage to shipment, delivering and distributing by wholesalers and selling by pharmacies. In addition, they are responsible for safety, quality and efficacy and pharmacovigilance of medicines. Two is by importers (Emergency companies). The main activity of them is supply those medicines which FDO announced as shortages. They could import medicines from registered wholesalers in confirmed countries based on its specific regulation. In this form of import, FDO rely on confirmed countries’ regulations to ensure about safety, quality and efficacy of required medicines.