ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and
their unrestricted access to all confidential infor- mation contained within the product file. Medical Devices To register a medical device, applicants must complete an application, which is to be sub- mitted to AMAR according to the relevant guidelines. This application must include valid regulatory approvals, encompassing safety and efficiency certifications issued by recognised certifying bodies abroad (eg, FDA, Conformité Européenne (CE), and International Organization for Standardization (ISO) approvals), or docu- mentation corresponding to the device’s class. In 2024, the MoH published guidelines for fast track registration of medical devices (see 4.1 Fast Track Registration Routes ). This is part of a reform in the registration procedure for medical devices that was published in August 2023 and is aimed at shortening the registration times of medical devices in Classes I and II. Requests to transfer registration to another holder must be submitted along with, inter alia, a letter of consent from the current registration holder, declarations from the manufacturer and the importer, and other requirements detailed in the MoH’s guidelines. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations Preparations and medical devices that are not registered may be supplied in specific circum- stances, as detailed here. Pharmaceuticals The Pharmacists Regulations (Preparations) of 1986 delineates certain exceptions to the regular requirements for preparations (such as registration and batch approvals), subject to
Medical Devices Pharmaceuticals
The basic requirement for marketing pharma- ceuticals and medical devices is their registra- tion, as noted in 3.3 Period of Validity for Mar- keting Authorisation for Pharmaceuticals or Medical Devices . To register a preparation, apart from adhering to the Pharmacists Ordinance of 1981 and the Pharmacists Regulations (Preparations) of 1986, applicants must submit an application to the Preparations Registration Department of the MoH. This application is exclusively available to Israeli residents or registered Israeli corporations and should be filed by a pharmacist approved by the MoH for such a purpose. The procedure adheres to MoH Circular No 08_2012 (“Application Submission Guideline for the Registration of Medical Preparations (Includ- ing Changes and Renewals)” ) (last updated in 2015). The circular classifies pharmaceutical preparations into six groups, including new APIs, generics, and biosimilars – each with specific requirements. Any change in a registered preparation should be brought to the attention of the MoH and the circular includes procedures for changing the registration (such as changes in indication, dos- age, and manufacturing plant). Another circular, No EX-009/04, relates to changes from a quality perspective and is based on the EC guidelines (mainly EC 1234/2008). MoH Guideline No 36 delineates the procedure for changing the registration holder. This process necessitates the manufacturer’s declaration regarding the new registration holder, including
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