ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
Pharmaceuticals In general, retail marketing of preparations can only be done by pharmacists in pharma- cies. Wholesale marketing of preparations can be carried out only by “pharmaceutical trading houses” , which store, distribute, and transport preparations or raw materials. According to the Pharmacists Regulations (Prep- arations) of 1986, the first registration of a prep- aration must not exceed five years. A renewal may be limited or unlimited in time, depending on quality, efficiency, or safety reasons. A registered preparation marketed for the first time must receive marketing authorisation from the MoH for the first batch. Marketing of any further batches requires the authorisation of a responsible pharmacist in a business that has received authorisation from the MoH to act as such. A preparation whose registration has not been renewed, or has been cancelled, may continue to be marketed for a period not exceeding one year from the expiration of the registration. Medical Devices The general rule for the first registration of a medical device is the same as for preparations – ie, it shall not exceed five years. This is accord- ing to the Medical Devices Regulations (Regis- tration of Medical Equipment in the Register and its Renewal) of 2013. The registration may be renewed. According to the Medical Device Law of 2012, a medical device whose registration has not been renewed or has been deleted or cancelled may continue to be marketed for a period not exceeding two years from the expiration of the registration.
Appeals are made to the deputy general director of the MoH. 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products In general, registration of original biologic medicinal products (which makes it possible to market those products – see 3.4 Procedure for Obtaining a Marketing Authorisation for Phar- maceuticals and Medical Devices ) requires that a quality certificate be obtained from the MoH for that product. Where a biosimilar – namely, a pharmaceutical comprising a biological active ingredient that is similar to the active ingredient of an already-reg- istered original biologic pharmaceutical – is con- cerned, MoH Guideline PRA-127/03 is applied. The guideline adopts the European Medicines Agency (EMA)’s policy regarding registration – with changes – and registration is usually dependent on showing actual registration for the biosimilar (or a positive opinion regarding it) from one of several foreign countries, as well as on the provision of data proving that there is no significant difference in aspects of quality, safety and efficacy between the biosimilar and the original biologic medicinal product. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices The basic requirement for marketing pharmaceu- ticals and medical devices is their registration. The initial period of validity for such registration is typically no more than five years and is subject to renewals. In certain circumstances, the MoH may prohibit the marketing of a preparation or medical device, revoke its registration, and take any action required to ensure public health.
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