Tofes 17
The standardized Israeli Ministry of Health form governing pharmaceutical and medical-device registration, pricing, and reimbursement within the national health system.
Tofes 17 (טופס 17, literally "Form 17") is the standardized application form issued by the Israeli Ministry of Health's Pharmaceutical Administration. It is the regulatory gateway through which pharmaceutical companies, medical-device manufacturers, and importers apply for marketing authorization, pricing approval, and inclusion in Israel's national health system reimbursement framework.
Every drug or medical device sold in Israel must pass through the Tofes 17 process. The form covers clinical-data submission, bioequivalence studies (for generics), pricing calculations pegged to international reference baskets, and classification within the Sal HaTziyud (Health Services Basket) framework. The Ministry of Health's Pharmaceutical Division reviews Tofes 17 submissions and determines whether a product qualifies for inclusion in the basket of services that Israel's four health funds — Maccabi, Clalit, Leumit, and Meuchedet — are legally required to provide.
For multinational pharmaceutical companies entering the Israeli market, the Tofes 17 process is the single most consequential regulatory touchpoint. It determines both whether a product can be sold and at what price. The pricing mechanism within Tofes 17 references basket prices in comparator countries — typically the UK, France, Germany, Belgium, the Netherlands, Spain, and Italy — creating a structural ceiling on Israeli pharmaceutical pricing that is generally 30–50% below US list prices.
See also: Tofes 17: The Form That Runs Israel's Healthcare Economy