ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
Registered Pharmaceuticals “preparation” or “medicinal drug” should be registered in the Israeli Drug Registry accord- ing to the MoH’s requirements (see 3.1 Product Classification: Pharmaceuticals or Medical Devices ). Registered preparations can be further categorised as follows. • Prescription Only (Rx) – prescription-only preparations may be provided only to con- sumers with a prescription at pharmacies and by certified pharmacists. • OTC Medicines – P (Pharmacist) – a prepa- ration whose provision does not require a pre- scription yet is provided only in pharmacies by certified pharmacists. • OTC – General Sale List (GSL) – non-pre- scription preparations that may be provided to consumers not by pharmacists and outside pharmacies, according to the Pharmacists Regulations (sale of a preparation without a prescription not in a pharmacy or not by a pharmacist) of 2004 and the MoH guidelines of 2011. The regulation includes a list of the active pharmaceutical ingredients (APIs) that may be included in GSL preparations. Non-Registered Pharmaceuticals The general rule is that it is not possible to pro- vide consumers with a preparation unless it is registered. This is also the case for off-label uses of registered preparations, as was determined by the Israeli Supreme Court in the Tibet case of 1984. However, the MoH may allow specific prepara- tions to be imported, manufactured or marketed without registration or in an off-label manner for uses such as research or essential treatments or for export purposes, provided the MoH deter- mines it will not negatively impact public health. Such allowances may also be made in cases
In addition, any Israeli citizen has the right to file an administrative appeal with the administra- tive courts against the decision of any authority, provided that the decision pertains to matters outlined in the Administrative Matters Courts Law of 2000. In the healthcare sector, decisions subject to challenge may include those entered under the Pharmacists Ordinance of 1981, the National Health Insurance Regulations of 2012, the Organ Transplantation Law of 2008, the Pub- lic Health Protection (Food) Law of 2015, and any authority’s decision concerning importa- tion under any law, including specific decisions regarding importation licences. Moreover, governmental decisions can be chal- lenged before the Supreme Court. The Supreme Court also hears appeals and applications for leave to appeal lodged against decisions of the district courts serving as administrative matters courts. In January 2025, the MoH published a draft bill titled the “Healthcare Services Quality Assurance Law 2025” for public opinions and comments. The bill aims to improve compliance, enhance the MoH’s regulatory role, and strengthen enforcement by introducing measures such as a broader authority to demand information, levy - ing financial penalties, and the expansion of the MoH’s oversight of HMOs and medical institu- tions. 1.3 Different Categories of Pharmaceuticals and Medical Devices There are two main categories of pharmaceu- ticals and medical devices in Israel – namely, registered and non-registered. These can be divided into further categories, as described here.
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