Law of Pharmaceutical and Herbal Establishments and
Art. 1Status 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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