Registration of pharmaceuticals in Israel and its exemptions

The requirement to obtain a preliminary approval for every pharmaceutical product in order to allow its regular distribution is an accepted practice worldwide. In Israel, the preliminary approval is known as registration in the national drug registry. The mechanism of drug registration has been in place since 1964, and is now based on Article 47A(b) of the Pharmacists Ordinance [New Version], 1981. The procedure of pharmaceutical registration is designed to assure that all pharmaceuticals marketed in Israel would prove to be safe, efficacious and of proper quality. However, in certain cases, it may lead to prevention of the distribution of necessary products that could not be registered for various reasons. In the context of pharmaceuticals, the unavailability of certain products may leave patients without proper treatment and put them in serious danger. This problem requires the duty of registration to have some exemptions. These exemptions must be balanced between the desire to assure a high level of preliminary evaluation of pharmaceutical products on the one hand, and the healthcare system's need to use products which have not been fully examined, on the other hand. This article analyzes the Israeli model of the exemptions from the duty to register drugs.