The Pharmacists Regulations – Good Manufacturing Practice is one of the primary pieces of legislation in Israel governing the marketing approval of medicinal products. No one may manufacture or import a medicinal preparation without approval for their business. The Director approves only if the business holds a valid license, complies with the regulations, is managed by qualified professionals (including a quality assurance manager and, where required, a responsible pharmacist or professional), follows Good Manufacturing Practice (GMP), and has passed a Director’s inspection. Authorizations are valid for five years and may be renewed. The Regulations define (i) Operational Obligations (Articles 6–11), including ensuring that products meet standards of strength, quality, and purity, implementing an effective Quality Assurance system, obtaining prior approval and a clear contract for third-party manufacturing, meeting infrastructure requirements for facility size, maintenance, and equipment, and maintaining production controls such as defect investigations and periodic validation of manufacturing processes; (ii) Quality Assurance, including (a) batch release, (b) keeping of production records for a given period, (c) keeping samples for testing, (d) rules for quality complaints; (iii) Professional Roles and Supervision (Articles 17-23) establishing that the responsible pharmacist must ensure all batches are manufactured and tested according to registration and approve their release. The Director has the authority to inspect premises, request documents, collect samples, and seize or destroy harmful products, and may suspend or revoke an authorization if the business endangers public health or violates regulations.
Israel · 2008-01-01