This Ordinance, comprising 68 articles, establishes the legal requirements for licensing medical professionals in pharmacy, the operation of pharmacies, and the manufacturing and marketing of medications. Its main goals are to ensure public health by supervising the quality, safety, and efficacy of medical preparations and defining the professional responsibilities of those who handle them. Under Articles 2–9, the practice of pharmacy is strictly regulated through mandatory licensing, and establishes an Advisory Committee to guide the Minister of Health on licensing matters. Articles 23–35 regulate the dispensing of medications, establishing that prescriptions are generally required, even though pharmacists may dispense certain medications without one in urgent cases, subject to strict verification and documentation. Additionally, the Law mandates rigorous labeling standards for medical preparations and poisons to ensure safety and prevent errors. Articles 42–47 mandate that all medical preparations be officially registered before they can be legally manufactured or marketed. To ensure safety and quality, manufacturers and importers must strictly adhere to international standards, specifically Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) throughout the production and supply chain. Articles 56–60 outline the framework for professional conduct and legal accountability. The Minister of Health is empowered to establish ethical codes, while regulatory authorities may suspend or cancel licenses for professional misconduct. Additionally, the Ordinance defines specific criminal offenses, such as marketing unregistered drugs or operating without a responsible pharmacist, which are punishable by fines or imprisonment. The Ordinance also treats veterinary drugs, with the same level of regulatory scrutiny as human medications, requiring official registration, professional oversight by veterinarians or pharmacists, and adherence to strict manufacturing and distribution standards. In particular, (i) Article 1 (Definitions): The legal definition of a "medical preparation" or "drug" explicitly includes substances used to treat, prevent, or cure diseases in animals, or those intended to affect an animal's physiological functions. This article also defines a "Veterinary Physician" as a recognized professional within the drug administration and prescription cycle; (ii) Articles 40 and 53, on Dispensing and Wholesale, grant veterinary physicians the authority to issue prescriptions and allow wholesalers or manufacturers to sell medical poisons and drugs directly to licensed veterinarians; (iii) Article 47 on Registration mandates that all veterinary medications must be registered in the official "Registry" before they can be legally manufactured or marketed; (iv) Article 47(3) on the Exemptions includes specific procedural variations for the registration of preparations that contain animal-derived materials.
Israël · 1981-01-01