Chapter 1: Definitions
The primary purpose of the Authority is to organize and monitor food, drugs, medical devices, and related products, and to establish the necessary regulations for them. The Authority undertakes all regulatory, executive, and supervisory tasks necessary to achieve its assigned purposes and the objectives to be accomplished, in order to ensure
First: The safety and security of food for humans and animals, through:
1- Organizing the monitoring of food to ensure its safety and quality, and to achieve this, it may include but is not limited to the following:
1/1- Establishing technical regulations and specifications for food.
2/1- Setting health specifications and requirements for food establishments and their employees.
3/1- Registering locally produced and imported food products.
4/1- Licensing and monitoring food establishments.
5/1- Monitoring imported and locally produced food products.
2- Organizing the monitoring of animal feed to ensure its safety and quality, and to achieve this, it may include but is not limited to the following:
1/2- Establishing technical regulations and specifications for feed.
2/2- Setting health specifications and requirements for feed factories and their employees.
3/2- Registering locally produced and imported feed products.
4/2- Licensing feed factories.
5/2- Testing imported and locally produced feed to ensure its safety.
3- Organizing the monitoring of pesticides to ensure their safety and quality, and to achieve this, it may include but is not limited to the following:
1/3- Setting health specifications and requirements for pesticide factories and their employees in cooperation with relevant authorities.
2/3- Registering imported and locally produced pesticide products.
3/3- Licensing pesticide factories.
4/3- Testing imported and locally produced pesticides to ensure their safety.
Second: The safety, security, and efficacy of drugs for humans and animals, through:
1- Organizing the circulation of drugs and biological products and monitoring them to ensure their quality, safety, and efficacy for humans and animals, and to achieve this, it may include but is not limited to the following:
1/1- Registering and re-registering pharmaceutical and biological product companies and their products.
2/1- Monitoring them after marketing.
3/1- Licensing pharmaceutical establishments.
2- Organizing the circulation of health products, herbal products, and plants and herbs with medical claims to ensure their safety for humans, and to achieve this, it may include but is not limited to the following:
1/2- Registering and re-registering health product and herbal product companies and their products.
2/2- Monitoring them after marketing.
3- Organizing the circulation of cosmetics to ensure their safety for humans, and to achieve this, it may include but is not limited to the following:
1/3- Approving their specifications.
2/3- Registering them before allowing their circulation.
3/3- Monitoring them.
4- Organizing the conduct of clinical studies for unregistered drugs in the Kingdom and registering clinical studies on drugs.
Third: Ensuring the safety of medical and diagnostic devices, laboratory materials, medical glasses, contact lenses, and their solutions, and the accuracy of their calibration and methods of use to prevent or minimize their impact on human health, and to achieve this, it may include but is not limited to the following:
1- Approving their specifications.
2- Registering them before allowing their circulation.
3- Monitoring them.
4- Licensing their establishments.
5- Ensuring compliance by operators of those devices with the technical calibration rules and procedures adopted by the Authority and the instructions of the manufacturers.
Fourth: Ensuring the safety of electronic devices that affect human health, and the accuracy of their calibration and methods of use to prevent or minimize their impact on human health, and to achieve this, it may include but is not limited to the following:
1- Approving their specifications.
2- Registering them before allowing their circulation.
3- Monitoring them.
Without prejudice to the regulations that are implemented by other governmental entities, each main sector in the Authority reviews the applicable laws and regulations related to its area of competence and proposes the necessary amendments in preparation for submitting them to the Council.
The Authority shall establish technical regulations and specifications in the fields of food, medicine, medical devices and products, laboratories, laboratory and diagnostic materials, biological and health preparations, medicinal plants, animal feed, pesticides, cosmetics, medical glasses and contact lenses and their solutions, electronic products that affect human health, and everything related to the scope of the Authority's work.
The Authority shall establish guidelines for the practice of good manufacturing and any other standards related to food, medicine, medical devices, products, pesticides, animal feed, and anything related to the scope of the Authority's work.
The authority prepares the evidence related to the health and technical requirements that must be met in the following facilities and establishments:
A- Food establishments and their employees.
B- Water factories and their employees.
C- Pharmaceutical establishments and their employees.
D- Medical devices and supplies establishments.
E- Establishments for laboratory and diagnostic materials, optical glasses, contact lenses, and their solutions.
F- Pesticide factories.
G- Feed factories.
H- Shops related to public health that fall within the authority's jurisdiction.
The authority establishes the necessary controls and procedures for inspecting the products that fall within its jurisdiction, as well as the raw materials used in production or manufacturing.