ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Wholesale marketing of preparations can be done only by “pharmaceutical trading houses” that store, distribute and transport preparations or raw materials (as noted in 3.3 Period of Valid- ity for Marketing Authorisation for Pharmaceu- ticals or Medical Devices and 3.8 Rules Against Illegal Medicines and/or Medical Devices ). The pharmaceutical trading houses should be man- aged by a pharmacist approved by the MoH according to MoH Guideline 139. Medical Devices Pharmaceuticals Wholesale is also allowed by institutions that have been acknowledged by the Minister of Health. The Minister of Health is also authorised to allow wholesale in other cases for necessary treatment, research or registration, provided such actions do not pose any detriment to pub- lic health. Distribution and storage should be according to MoH Guideline 126 and MoH Guideline 130. Non-prescription medicines may be sold subject to approval by the district pharmacist according to the Pharmacists Regulations (sale of medi- cine without a prescription not in a pharmacy or not by a pharmacist) of 2004 and under MoH Guideline 56. Medical Devices The sale of medical devices necessitates regis- tering the equipment in the registry – although exceptions may exist (see 3.4 Procedure for Obtaining a Marketing Authorisation for Phar- maceuticals and Medical Devices and 3.5
manager, a lead pharmacist, and a business manager; • the preparations should be manufactured according to good manufacturing practices (GMP) and the principles of EU Directive 2003/94/EC for human preparations; • the APIs used in manufacturing the prepa- ration should be manufactured according to GMP and the principles of EU Directive EC/2001/83; • the MoH must audit the business accord- ing to the EMA’s “Compilation of Community Procedures on Inspections and Exchange of Information” ; and • the plant must have a business licence pursu- The manufacturing of medical devices is regu- lated by the Medical Devices Law of 2012, the Medical Devices Regulations (Registration of Medical Equipment in the Register and its Renewal) of 2013 and the MoH’s guidelines. The manufacturing plant’s GMP should meet the requirements of ISO 13485, as well as have a business licence pursuant to the Business Licensing Law of 1968. Transportation conditions must meet the require- ments of ISO9001. Businesses also require an appropriate business licence for the storage and transportation of medical devices pursuant to the Business Licensing Law of 1968. ant to the Business Licensing Law. Manufacturing of Medical Devices
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