These Regulations establish the framework and procedures for the registration, importation, renewal, and cancellation of medicinal products. The Ministry of Health is responsible for overseeing the registration process, ensuring that each medicine is safe, effective, and manufactured in accordance with appropriate quality standards. In particular, the Regulations provide for (i) the establishment of a registry divided into three categories - human medicinal preparations, human medical food preparations, and veterinary medicinal preparations; (ii) the mandatory registration of preparations prior to marketing, which must generally be pre-packaged at the manufacturing site unless otherwise authorized by the Director General, and granted only upon proof of safety, efficacy, proper naming, and compliance with Good Manufacturing Practices (GMP), along with an obligation for the registration holder to maintain an ongoing pharmacovigilance system; (iii) the requirements for obtaining import permits, including conditions for transport and storage; (iv) the authority of the Director to amend registration conditions, impose additional requirements such as usage restrictions or post-marketing surveillance, and to cancel registrations or recall products if they are found to be unsafe, ineffective, or non-compliant; and (v) labeling requirements mandating that packaging clearly display key information, including trade and generic names (in Hebrew and Latin letters), registration holder details, batch number, production date, and expiration date. Veterinary medical preparations are regulated within a dedicated section of the official Registry and are generally subject to the same requirements as human medicines, including mandatory registration, and compliance with safety, efficacy, and Good Manufacturing Practices (GMP). Veterinarians are recognized as authorized prescribers, and standard labeling requirements apply, though some consumer-oriented labeling rules may be adapted or exempted for veterinary use. Medical food preparations for human use are regulated as a distinct category within the official Registry and must be registered, meeting requirements for safety, efficacy, and compliance with Good Manufacturing Practices (GMP), supported by quality certification. They are also subject to specific labeling and leaflet requirements, including preparation instructions and mandatory information in Hebrew and Arabic to ensure proper and safe use.
Израиль · 1986-01-01