Law of the General Food and Drug Authority

Article 1: Definitions

  • In this Law, the following terms shall have the meanings assigned thereto, unless the context requires otherwise:

    • SFDA: Saudi Food and Drug Authority.

    • Board: SFDA’s board of directors.

    • Executive Director: SFDA’s executive director.

    • Food: Any substance intended for human consumption whether fresh, manufactured, semi-manufactured, or raw, and any substance used in the manufacturing, preparation, or processing of food.

    • Drug: Any substance used in the diagnosis, treatment, or prevention of diseases in humans or animals.

    • Pesticide: Any substance used to exterminate pests harmful to agriculture and public health.

    • Biologicals: Include blood derivatives, vaccines, serums, and anything manufactured or extracted from humans or animals or contains substances from either source.

    • Health-Related Products: Includes raw materials related to food and drugs; cosmetics; health preparations; medicinal plants; radioactive equipment and products used in the diagnosis or treatment of diseases; and electronic equipment that may affect health.

    • Water: Includes bottled and non-bottled drinking water, natural mineral water, groundwater, medicinal spring water, water used in renal dialysis, bottled water intended for children and infants, as well as distilled or ion free water of special uses in hospitals and laboratories.

    • Medical Equipment: Any device, machine, or instrument used in the diagnosis, treatment, control, or prevention of diseases.

    • Food Establishment: Any establishment which manufactures, stores,markets, prepares, handles, serves, or displays food intended for human consumption, whether consumed inside or outside the premises, excluding home kitchens.

    • Medical Supplies: Medical substances and products used in the treatment, diagnosis, prosthetics, correction, disability cases, and other medical uses for humans, including medical gases.

    • Animal Feed: All that is intended to feed food-producing animals, whether single or mixed substances; manufactured, semi-manufactured, or raw; or any substance used in the manufacture, preparation, or processing thereof.

Article 2

  • The SFDA shall have a legal personality and financial and administrative independence and shall report directly to the President of the Council of Ministers. The SFDA shall be headquartered in the city of Riyadh and it may, if necessary, establish branches or offices.

Article 3

  • The SFDA shall aim to regulate the monitoring of food and drugs by setting mandatory and optional standard specifications therefor and for products within its jurisdiction, monitor and test the same in its laboratories or other laboratories chosen thereby, and raise consumer awareness with regard to food and drugs, in order to ensure that:

    • 1. food is safe for humans and animals;

    • 2. drugs are effective and safe for humans and animals;

    • 3. biologicals, health preparations, medicinal plants, pesticides, cosmetics,

    • prescription glasses, contact lenses and their solutions are safe for humans;

    • 4. electronic products are safe for humans; and

    • 5. medical and diagnostic equipment meet standards and are safe for humans.

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Article 4

  • The SFDA shall conduct its business in a commercial manner and shall have all powers necessary to carry out its duties.

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Article 5

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Article 6

Previous Amendments

The authority shall have a Board of Directors, formed of a President appointed by Royal Order, and the membership shall be as follows:
- A representative from the Ministry of Municipal and Rural Affairs as a member
- A representative from the Ministry of Interior as a member
- A representative from the Ministry of Health as a member
- A representative from the Ministry of Commerce and Investment as a member
- A representative from the Ministry of Environment, Water, and Agriculture as a member
- A representative from the Ministry of Energy as a member
- A representative from the Ministry of Economy and Planning as a member
- A representative from the Ministry of Finance as a member
- A representative from the Ministry of Higher Education as a member
- A representative from the Ministry of Industry and Mineral Resources as a member
- The Chief Executive Officer of the General Authority for Food and Drug as a member
- The Director General of the Saudi Standards, Metrology and Quality Organization as a member
- Four representing the chambers of commerce and industry in the Kingdom from businessmen related to the field of work of the authority, nominated by the Council of Saudi Chambers of Commerce and Industry for a term of three years, renewable once, and their appointment is issued by a decision of the Council of Ministers as members
- Two specialists in the field of work of the authority, one in food and the other in medicine, nominated by the President of the authority for a term of three years, renewable once, and their appointment is issued by a decision of the Council of Ministers as members
- A representative from the Public Health Authority as a member

- A representative from the Culinary Arts Commission as a member
The President of the Council shall appoint a Vice President from among the members of the Council.

Article 7

  • The Board shall be the SFDA’s highest authority and shall oversee its management and the conduct of its affairs. The Board shall make decisions necessary to achieve its objectives in accordance with this Law and shall, in particular, have the following powers:

    • 1. Approving the SFDA’s general policy and monitoring its implementatio

    • . 2. Approving the mandatory standard specifications of products falling within the SFDA’s jurisdiction and the rules for importing, exporting, and registering such products, as well as approving requirements for food and drug factories.

    • 3. Approving the administrative and financial approaches appropriate for managing the SFDA to enable it to achieve its objectives.

    • 4. Approving and issuing the administrative, financial, and technical regulations appropriate for the SFDA’s duties and the management thereof.

    • 5. Approving the rules and procedures for forming scientific and technical committees and work teams as well as determining the remunerations of its members.

    • 6. Approving the plans necessary for achieving the SFDA’s objectives.

    • 7. Approving the SFDA’s draft annual budget.

    • 8. Approving the SFDA’s annual report at the end of each year prior to submission to the President of the Council of Ministers.

    • 9. Approving the SFDA’s final accounts prior to submission to the Council of Ministers.

    • 10. Assigning an auditor, or more, to the SFDA’s accounts and approving his reports.

    • 11. Accepting aid, donations, gifts, bequests, and endowments.

    • 12. Approving the establishment of branches and offices for the SFDA.

Article 8

  • The Board may delegate some of its powers to its Chairman or to the Executive Director.

  • The Board may form committees from among its members or others to carry out certain tasks.

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Article 9

  • Board meetings shall be held periodically at least twice a year. The Board shall also convene, if the need arises, upon a call by the Chairman.

Article 10

  • Board meetings shall be chaired by the Chairman or the Vice Chairman and shall be deemed valid only if attended by the majority of its members. Decisions shall be passed by the majority vote of attending members. In case of a tie, the Chairman shall have the casting vote

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