ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
MoH approval/requirements. These exceptions include materials used without any process or change, preparations in non-commercial and small quantities, personal use of such, use for research, local manufacture for export purpos- es, use for epidemic purposes, and registered preparation for off-label use. The MoH published several guidelines con- cerning the exceptions, which include various requirements, forms and approvals. Medical Devices The Medical Device Law of 2012 grants author- ity to the Minister of Health to establish regu- lations governing exceptions to the registra- tion requirement under specific circumstances outlined in said law. Such regulations have not yet been enacted. However, in August 2023, the MoH released draft regulations, which proposed allowing the use of unregistered medical devices in the following cases: • essential medical treatment and urgent care in the absence of a registered, marketed and available alternative; • compassionate treatments; • research, development and production of medical equipment not intended for market- ing purposes; • emergency preparedness; • export-only purposes; • conducting clinical evaluations of a limited number of patients; and • personal use of customised medical equip- ment by a therapist. 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations “Pharmacovigilence” is defined here as the phar- macological science relating to the detection,
assessment, understanding and prevention of adverse effects – in particular, the long-term and short-term side effects of medicines. “Technovigilance” is defined here as the science relating to the detection, assessment, under- standing and prevention of adverse incidents – in particular, the long-term and short-term side effects of medical devices. Pharmaceuticals The preparation registration owner must main- tain a drug monitoring system – for which, a physician/pharmacist with at least two years’ experience will be responsible. The preparation registration owner must notify the MoH of any change in the registration file. MoH Guideline No 6 (“Reporting Adverse Events and New Safety Information” ) details which information should be provided and additional relevant requirements. Among other things, the MoH’s guidelines require creating a system for monitoring side effects and new safety infor- mation for the registered preparation (pharma- covigilance system), providing Periodic Benefit- Risk Evaluation Reports (PBRER) or Periodic Safety Update Reports (PSUR), post-marketing spontaneous reporting of individual case safety reports, and follow-up on serious side effects. The MoH may impose additional conditions on registration or renewal of the preparation, such as requiring regular and ongoing supply of the preparation. Medical Devices Section 7 of the Medical Device Law of 2012 out- lines the parameters that the MoH may impose during the registration phase of medical devices. These include requirements for transportation and storage, the regular supply of the medical
176 CHAMBERS.COM
Powered by FlippingBook