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Client Updates

Dec 25, 2016

Pharma Client Update | New Version of "Regulation 29" to Take Effect

While the Israeli regulation generally prohibits the marketing of medicinal products, unless they are registered in the Medicinal Product Registry in the Ministry of Health and in accordance with their terms of registration, it sets a complex system of exemptions, which enables the use of non-registered medicinal products and off-label use of registered products. The basic rules for applying the exemptions, generally known as "Regulation 29" (according to the relevant provision in the Pharmacists Regulations (Medicinal Products), 1986), are specified in a formal Notice published in Official Gazette.

On December 20, 2016, a new version of the Notice will take effect. The Client Update reviews the main changes in the new version of the Notice as compared to the existing one. The changes include the introduction of a new exemption applying to the use of products classified as Advanced Therapy Medicinal Products in hospitals, as well as changes in provisions referring, inter alia, to personal importation, compassionate use, importation of veterinary medicinal products, compounding in pharmacies etc.

To read the full update (Hebrew), click here