The Council of Ministers,
after perusal of Royal Court File 70415 dated 4 Dhu Al-Hijja 1442 [25 June 2021], which includes the Minister of Commerce, Chairman of the Board of Directors of the National Competitiveness Center Telegram 04785 dated 19 Safar 1442 [20 September 2020] regarding the approval of the amendment to the Private Laboratories Law,
after perusal of the Private Laboratories Law issued by Royal Decree D/3 dated 8 Safar 1423 [28 February 2002],
after perusal of Bureau of Experts at the Council of Ministers Minutes 288 dated 9 Jumada Al-Awwal 1442 [21 December 2020], Minutes 491 dated 8 Sha’ban 1442 [23 March 2021], Minutes 611 dated 13 Shawwal 1442 [22 April 2021], and Minutes 40 dated 22 Muharram 1443 [18 August 2021],
after perusal of Council of Economic and Development Affairs Recommendation 38-7/43/I dated 9 Safar 1443 [16 September 2021],
after considering Shura Council Decision 209/39 dated 27 Dhu Al-Qa’dah 1442 [26 June 2021],
and after perusal of General Committee of the Council of Ministers Recommendation 2053 dated 11 Rabi Al-Awwal 1443 [17 October 2021],
hereby decides
Articles 1, 3, 4, 6, 7, 8, 9, and 16 of the Private Laboratories Law issued by Royal Decree D/3 dated 8 Safar 1423 [28 February 2002] are hereby amended as follows:
1․ Article 1(a):
(a) Competent entity: The Ministry of Commerce, the Ministry of Health, the Ministry of Environment, Water, and Agriculture, the Ministry of Industry and Mineral Resources, the Ministry of Municipal and Rural Affairs and Housing, or the Saudi Food and Drug Authority, and or other government entities specified by the executive regulation, as required by the text or context.
2․ Article 1(b):
(b) Center: The Saudi Accreditation Center.
3․ Article 3:
The license must be granted to the laboratories provided that the license applicant is committed to providing the necessary cadres of scientifically qualified specialists, and the equipment and devices necessary to work in the laboratory in accordance with the volume and nature of the work, as determined by the competent entity and the center.
4․ Article 4:
The executive regulation must specify the categories of laboratories and the conditions that must be met for each category, based on a recommendation from the center.
5․ Article 6:
The licensee must be given a period not exceeding one and a half years starting from the date of obtaining the license to complete obtaining the accreditation from the center. In the event that the deadline expires without obtaining the accreditation, the license is considered canceled.
6․ Article 7:
(a) The competent entity shall issue the license to the private laboratory after paying the license fee, which is 5,000 Riyal for the main laboratory, and 2,500 Riyal for each branch.
(b) The validity period of the license is five years starting from the date of the grace period mentioned in article 6 of this law, and it is renewed by a request from the concerned party submitted to the competent entity at least three months before the date of its expiry. The renewal must be from the date of expiry of the license.
7․ Article 8:
The competent entity shall issue a decision on the goods to be inspected by the private laboratory 60 days before the assignment of the task to the private laboratory, and after announcing it in the official gazette. The Zakat, Tax and Customs Authority must be informed of this.
8․ Article 9(d):
(d) Presenting the license and the accreditation certificate from the center in a visible place at the entrance to the laboratory, and not making any amendment to it except after its approval by the competent entity.
9․ Article 16:
The Minister of Commerce—in agreement with the Ministry of Interior, Ministry of Health, Ministry of Environment, Water, and Agriculture, Ministry of Industry and Mineral Resources, Ministry of Municipal and Rural Affairs and Housing, and the Saudi Food and Drug Authority—shall issue the executive regulation of this law.
A draft royal decree has been prepared in the form attached.
The Prime Minister
Issued on: 4 Rabi Al-Thani 1443
Corresponding to: 10 November 2021
Published in Umm Al-Qura 4910 issued on 26 November 2021.