Alqanoni

Law of Pharmaceutical and Herbal Establishments and

Art. 1
Status unknownSaudi ArabiaRegulation

Issued by Ministry of Investment (misa.gov.sa)

In this Law, the following words and phrases shall have the meanings assigned thereto, unless the context requires otherwise: Law: Law of Pharmaceutical and Herbal Establishments and Preparations. Authority: Saudi Food and Drug Authority. Board: Board of Directors of the Authority. CEO: Chief Executive Officer of the Authority. Pharmacist: A person holding a bachelor's degree in pharmaceutical sciences or a doctor of pharmacy degree from a college of pharmacy in the Kingdom, or their equivalent. Pharmacy Technician: A person holding a pharmacy technician degree from a health institute or college in the Kingdom, or its equivalent. Pharmaceutical Preparation (Medication): A pharmaceutically manufactured product which contains one or more substances used externally or internally in the treatment or prevention of human diseases. Herbal Preparation: Any plant or herb with therapeutic claims that is pharmaceutically prepared. Counterfeit Pharmaceutical or Herbal Preparation: A preparation the content, identity, or source of which is intentionally altered with the intent to deceive, even if the ingredients remain the same, including preparations with trademarks and generic marks. A pharmaceutical or herbal preparation shall be deemed counterfeit if it is contaminated; contains contaminated, incorrect, inactive, or ineffective ingredients; does not contain active ingredients; or is packed in counterfeit packages. Spoiled Pharmaceutical or Herbal Preparation: A preparation the properties of which have changed, rendering it unfit for use. Pharmaceutical Establishment: Any pharmaceutical and herbal preparations factory or wholesale warehouse, scientific office, or medicinal consultation or pharmaceutical and herbal preparations analysis center. Pharmacy: An establishment where pharmaceutical and herbal preparations are prepared and dispensed or sold. Pharmaceutical and Herbal Preparations Wholesale Warehouse: A pharmaceutical establishment which imports, distributes, or sells pharmaceutical and herbal preparations wholesale. Scientific Office: A pharmaceutical establishment which provides scientific, technical, and marketing information on pharmaceutical and herbal preparations in the Kingdom. Herbal Preparations Outlet: An establishment where herbal preparations are prepared and sold. Law of Pharmaceutical and Herbal Establishments and Preparations Medicinal Consultation or Pharmaceutical and Herbal Preparations Analysis Center: A pharmaceutical establishment that provides medicinal consultations, analyzes pharmaceutical and herbal preparations, conducts bioavailability and bioequivalence studies, controls the quality of medicines, and determines drug levels in biological fluids Regulations: Implementing Regulations of this Law.

The Arabic text is the legally binding version. The English translation is provided for guidance only.

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