Application for registration must be made by a Romanian sponsor, a Romanian agent, distributor or company based in Romania . New drugs must be registered if they are new to the Romanian market and are innovative and of good quality. Labels and leaflets must be translated into Romanian. Fluctuation of the exchange rate over the past year has been significant and companies should take this into consideration in making deals. There are approximately 300 manufacturers, importers and distributors of drugs on the Romanian market.
Sales are mainly by state tender or direct purchase.
The distributing company must have good quality contacts in Romania , in order to have access to appropriate authorities with decision-making power in purchasing. Otherwise, the chances are reduced, even with good price and quality. Suppliers contact hospitals and pharmacies directly. The OTC market is growing due to increased marketing and advertising of products directly to the consumer. There is some distrust of advertising by medical or pharmacy staff.