Authority Establishment

Establishment of A General Authority for Food and Drug

The Council of Ministers upon review the packet coming from the Cabinet Presidency Bureau no 7/B/38314 dated 24/09/1423 H, includes the letter of HRH Second Deputy Premier and Minister of Defense and Aviation and General Inspector, chairman of Ministerial Committee for Administrative Organization no 31/4/16/17/105 dated 01/09/1423H. Enclosed with minutes of (fifth) meeting for The Ministerial Committee for Administrative Organization, formed by telegraphic royal decree no (7/B/6629) dated 07/05/1420 H, that propose re-structuring of part of governmental sectors among them incorporation of a High Authority for Food and drug supervision.

And upon review of (fifth) meeting’s minutes of Ministerial Committee for Administrative Organization constituted by the telegraphic royal decree no (7/B/6629) dated 07/05/1420H.

And upon review of item (2) of article (24) of Cabinet’s law issued under royal decree no (A/13) dated 03/03/1423 H.

And upon review of the General Committee of the Cabinet’s recommendation no (551) dated 24/11/1423H.

The following have been decided:

• First: Establishment of A General Authority for Food and Drug supervision that has its own entity and autonomous budget. Directly report to the Council of Ministers and assume the procedural, executive, and supervisory tasks which carried out by the currently existing agencies.
• Second: The main objectives of the Authority shall be as follows:
  • Safety, secure, and effectiveness of food and drugs for human and animal.
  • Secure of complementary chemical and biological substances, cosmetics, and pesticides.
  • Safety of electronic products not to impact on public health.
  • Standards accuracy and safety of medical and diagnostic equipments.
  • Launch a clear policy for food and drugs and planning to achieve this policy’s objectives.
  • Conduct researches and applied studies to identify health problems, its causes and determine its impact, including evaluation methods of researches and studies. Construct scientific base to avail in educational, advisory services and executive programs in the field of food and drugs. This shall be via specialist to join the Authority in addition to cooperation with research agencies as King Abdul Aziz City for Science and Technology (KACST) and scientific research centers in universities.
  • Oversee laws and procedures of licenses for food and drugs’ factories and medical equipments.
  • Exchange and deployment of information with local and international scientific and legal agencies, and find a data base on food and drug.
• Third: The Authority shall incept its tasks on two phases, they are:
  

  First Phase: for a period of five years, this phase starts from effective date of this resolution – it will be considered introductory and threshold for the phase – in this period the Authority shall assume procedural, standardization, supervisory, and oversight tasks stipulated in annex no (1) attached hereto.

  
  

  Second Phase: begins at the end of the fifth year of the first phase, in this period the Authority shall assume – in addition to criterion and procedural tasks mentioned in the first phase- executive tasks stipulated in annex no (2) enclosed hereto.

• Fourth: The General Authority for Food and Drug shall have a Board of Directors compose of the following:
  • H.R.H Second Deputy Premier Chairman
  • H.R.H Minister of Interior Vice-chairman
  • Minister of Health Member
  • Minister of Commerce Member
  • Minister of Municipality and Rural Affairs Member
  • Minister of Agriculture Member
  • Minister of Water Member
  • Minister of Finance and National Economy Member
  • Minister of Industry and Electricity Member
  • Executive President of SFDA Member
  • General Director of Saudi Arabian Commission for Specifications and Standardizations Member
  • Chairman of Chamber of Commerce and Industry in the Kingdom Member
  • Specialist in food and drugs who has distinguish contribution and concern in this arena. Member
• Fifth: The SDFA shall have an executive president appointed in a grade not less than fifteenth.
• Sixth: During the fifth year (the last) of the first phase, the Board shall set and approve a plan to transit the Authority to the second phase.
• Seventh: The Authority shall manage its tasks in commercial pattern to observe the following:
  • Implement all prescribed pre-requisites of objectives achievement, related to administrative and financial aspects stipulated in annex no (3) attached hereto.
  • incrementally rely on its financing from own revenues that generated from prescribed fees on licensing, clearance, fines and others, which shall be earned from the services provided to beneficiaries.
• Eighth: The Experts Board in participation with (Ministry of Heath, Ministry of Commerce, Ministry of Municipality and Rural Affairs, Ministry of Agriculture, Ministry of Water, Ministry of Finance and National Economy, Ministry of Industry and Electricity, Ministry of Civil Service, Saudi Arabian Commission for Specification and Standardization) shall prepare a draft law for the Authority of Food and Drug. This law determines the objectives of the Authority and jurisdictions of its Board in conformity with trend set out in the report of the preparatory committee of the Ministerial Committee for Administrative Organization, which indicates that it shall practice its tasks in commercial pattern. This report will be submitted according to adopted regulatory procedures.
• Ninth: The Authority’s Board shall set the administrative structure and the regulatory guideline that coincide with Authority’s prescribed trends in the first and the second phases. The Board can guide by administrative structures of similar agencies and organizations.
• Tenth: The role of Saudi Arabian commission for Specifications and Standardizations will be restricted on tasks originally assigned to it, according to the law issued under the royal decree no (10/M) on 03/03/1392H, whereas all procedural and standardization tasks associated with food and drug will be conveyed to the General Authority for Food and Drug. As well as the tasks assigned to the Permanent Committee for Safety of Food formed under the royal decree no (7/9161/M) dated 11/11/1416H, and the cabinet resolution no (8) dated 10/01/1417H.
• Eleventh: The General Authority for Food and Drug shall have an appropriate executive body to perform its assigned tasks, during the first and the second phases. It shall be provided with equipments and central laboratories at Authority’s domicile and supported by specialized and competent manpower. The Authority can seek technical help from the capabilities of other governmental bodies and their laboratories such as (hospitals and universities). In addition to assistance by local and international private laboratories in accordance with appropriate form and method.
• Twelfth: The concerned parties- each in its field- shall act according to this resolution. As well as considering laws, rules, provisions, decisions, royal orders, and related circulars. And report the required finalization of regulatory procedures therein.

Chief of Council of Ministers