ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
Access to Pharmaceuticals and Medical Devic- es Without Marketing Authorisations ). 6.2 Different Classifications Applicable to Pharmaceuticals In Israel, there are two main categories of phar- maceuticals. The first is registered pharmaceu- ticals and the second is non-registered pharma- ceuticals. For a detailed explanation, please see 1.3 Different Categories of Pharmaceuticals and Medical Devices . 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies The importation and exportation of products are mainly governed by the Import and Export Ordi- nance of 1979, the Customs Ordinance of 2014, and the Free Import Order of 2014. In addition, specific regulations and MoH guidelines exist for the importation and exportation of pharma- ceuticals and medical devices; these make it necessary to obtain approvals from the Import of Pharmaceuticals and Drugs Department or AMAR. MoH Guideline 33 governs the submis- sion and handling of applications for import approval. MoH Guideline EX-015/02 outlines the procedures for granting, renewing, updating, suspending and revoking approvals for import- ers of pharmaceuticals. At the point of entry, the customs authorities are responsible for enforcing import regulations. Fol- lowing entry into the country, ongoing enforce- ment and oversight are maintained by various
entities within the MoH, such as the Pharmaceu- tical Administration and AMAR. A proposal for an amendment to the Patents Law of 1967 is currently pending. According to Amendment No 14 (Increasing Competitiveness in the Israeli Economy), 5781-2021, third parties shall be allowed to manufacture an otherwise infringing medical device or pharmaceutical dur- ing the period of a patent term extension (PTE) order – provided that the exploitation of the invention is made for export purposes or made for stockpiling and marketing in Israel during the final six months of the period of the PTE. 7.2 Importer of Record of Pharmaceuticals and Medical Devices There is no official definition of “importer of record” in Israel. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Importers of pharmaceuticals and medical devices are generally required to obtain prior authorisations from the MoH, as mentioned in 7.1 Governing Law for the Importation and Exportation of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies . The Pharmacists Ordinance of 1981 defines “marketing” as including importation; therefore, any approval required for marketing is also appli- cable for importation (see 3.3 Period of Validity for Marketing Authorisation for Pharmaceuti- cals or Medical Devices and 6.1 Wholesale of Pharmaceuticals and Medical Devices ). Exemptions exist, according to Regulation 29 of the Pharmacists Regulations (Preparations) of 1986 (see 1.3 Different Categories of Phar - maceuticals and Medical Devices ). In addition, in view of the war in Gaza, the MoH published a donation outline for medical devices that allows
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