Generic Registration Applications
This article was originally published in SRA
Executive Summary
New Israeli requirement following pharmacists’ ordinance amendment
New Israeli requirement following pharmacists’ ordinance amendment
The Pharmaceutical Administration of the Israeli Ministry of Health has issued a circular advising that, further to the amendment introduced in the Pharmacists’ Ordinance (New Version) - 1981 (the ordinance), concerning data exclusivity1, an application for the registration of a generic medicinal product must include a document signed by the appointed pharmacist of the applicant, detailing the exact date in full (day, month and year) in which the reference product was first listed in the register [Drug Register - Israel] or first approved for registration in a recognised country.
The new requirement applies to applications for the registration of generic products and to products containing a new chemical entity [as defined in the ordinance]. It came into force on 1 July 2005. The circular was issued on 20 June 2005.
ISAAC SETTON
References
1. The Regulatory Affairs Journal - Pharma, 2005, 16(7), 527-528
Note: Items in square brackets are the author's own insertions.