Private laboratories - Regulations
Ministerial Decision No.307, 21/2/1424 [21 April, 2003]
The English version of this document is for guidance only.
The Arabic version is the governing text.
Table of Contents
- The Initial License
- The License
- Procedures of License Renewal
- Assistance by Private Laboratories for the Purpose of Customs Clearance
- Seeking assistance from the Private Laboratories for the purpose of testing commodities produced locally and imported
- Obligations and Duties of the Laboratory
- Taking of Samples
- Classification of Laboratories
- Supervision of Laboratories
- General Provisions
The following terms whenever used in the Regulations shall have the meaning opposite to them:
- The Competent Ministry: Ministry of Interior, Ministry of Commerce, Ministry of Health, Ministry of Agriculture, Ministry of Industry and Electricity or the Ministry of Municipal and Rural Affairs.
- The Competent Minister: Minister of Interior, Minister of Commerce, Minister of Health, Minister of Agriculture, Minister of Industry and Electricity or Minister of Municipal and Rural Affairs.
- The Authority: The Saudi Arabian Authority for Specifications and Measures.
- The Commodities: The Commercial commodities produced locally or imported whether in the form of materials, products, equipments, tools or others.
- Sample: Samples taken from a consignment or commodities on scientific basis in accordance with the approved standard specifications.
- Test: Any analysis, standard or test to determine the constituents, qualities, aptitude, efficiency or conformity.
- Laboratory: Any place prepared to test any commodity, or checking an equipment.
- The Law: The Law of Private Laboratories.
- A Certificate of Approval: A Certificate of Approval issued by the Saudi Arabian Authority for specifications and measures in accordance with the requirements of the Laboratories Approval Regulations and the Saudi Standard Specification ISO 17025.
- The Approved Standard Specification: The Saudi Standard Specification or the Khaleej Standard Specification and in case there is no Saudi or Khaleej Standard Specification any other Standard Specification approved by the Board of Directors of the Authority may be applied.
The Initial License
The following authorities shall be competent to issue licenses for Private Laboratories:
- Ministry of Interior: Laboratories concerned with explosives and chemical materials that are used in the manufacture of explosives.
- Ministry of Health: Laboratories concerned with medicines, biological preparations, medical herbs and plants and sanitary preparations.
- Ministry of Agriculture: Laboratories relating to commodities mentioned in paragraph (b) of Article Eleven.
- Ministry of Commerce: Laboratories relating to all commodities except those mentioned in the previous paragraphs.
The competent Minister shall by a resolution determine the competent department to issue the licenses
The applications of Initial Licenses for Laboratories shall be submitted to the competent department specified in a resolution of the competent Minister. The application shall include the following :
- The approved form of initial license application shall be filled.
- A study of the project including the estimated cost, technical cadres and equipments shall be submitted.
- Evidence proving that the applicant is a Saudi shall be submitted whether he is natural or juristic person and in case of companies of foreign and mixed capital they must have a license from the General Investment Authority to authorize them to carry out the activity.
- An undertaking by the applicant to appoint a Saudi Technical Manager specialized in Laboratory works to be engaged on full time basis.
- An undertaking by the applicant to provide the necessary technical cadre of qualified specialists, the equipments required for work in the laboratory that suit the size and nature of work as determined by the Competent Ministry.
The competent department shall study the application and decide on it within thirty days from the date of submission and in case it is accepted the applicant shall be issued with an initial license authorizing him to complete the requirements of obtaining the final license and in case the application is rejected the reasons for rejection shall be stated and the applicant is entitled to complain from the resolution before the Competent Minister within the period determined by regulations.
The holder of an initial license shall be given a period of not more than six months to complete the following :
- The Organizational Framework of the Laboratory.
- Appointment of the Saudi Technical Manager and submission of an approved copy of his academic qualifications, experiences and training courses.
- Determining the technical cadre necessary to operate the laboratory and submission of an approved copy of their academic qualifications, experiences and training courses.
- Determining the installation and equipments necessary to operate the laboratory.
- The Approval Certificate from the Authority.
- Submission of approval by the Competent Authority or Municipality permitting the exercise of the activity in this place.
The initial license shall be cancelled in case the requirements stated in Article Five are not completed within six months.
The Competent Minister or the person authorized by him shall issue the license to the laboratory to carry out the activity after completing the following:
- Completing the requirements stated in Article Five.
- Determining the type of commodities and tests and the maximum cost of each test to be licensed after the approval of the Competent Minister of the recommendation of the Committee.
- Payment of the Fees of the license which is (SR 5,000) Five Thousand Saudi Riyals for the main laboratory and (SR 2,500) Two Thousand Five Hundred Saudi Riyals for each branch.
The period of validity of the license is five years.
Procedures of License Renewal
The Competent Authority shall renew the license at the request of the applicant for renewal who shall attach with it a recommendation from the authority before three months at least from the date of expiration of its period provided that the renewal is from the date of expiration of the period of the previous License.
The license shall be cancelled in accordance with a resolution by the Competent Minister if either the commercial registration or the Approval Certificate is cancelled.
Assistance by Private Laboratories for the Purpose of Customs Clearance
The Competent Minister shall issue, in case of need, the necessary resolution for seeking the assistance of private laboratories qualified and licensed to test imported commodities for the purpose of Customs Clearance in accordance with the requirements of the Resolution of the Council of Ministers No. 50 dated 17/3/1410 H. and No. 84 dated 1/4/1421 H. as follows:
- The Minister of Interior shall issue the necessary Resolution in relation to the following commodities:
- Chemical Materials that are used to manufacture explosives.
- The Minister of Agriculture and Waters shall issue the necessary Resolution in relation to the following commodities:
- All types of living meat animals.
- Living, predatory and wild animals.
- All types of living poultry, rabbits and young chickens.
- All types of ornament birds.
- All types of ornament fishes.
- Hatching eggs.
- Skins, hair, fur and wool which are of animal origin and free from any manufacturing processes.
- Concentrated fodders and their vitamins and mineral salts provided that their analysis and test shall include test of hormones if any in relation to the concentrated one.
- Veterinary Vaccines.
- Veterinary Medicines.
The Veterinary Medicines will not be cleared except by the competent committee formed for this purpose in the Ministry of Health in accordance with Royal Decree No. M/18 dated 18/3/1398 H. and its Implementing Regulations and in which a representative of the Ministry of Agriculture shall participate as a member.
- Organic Manures and Fertilized Soil.
- Agricultural Transplants.
- Ornament Plants.
- Bees Consignment.
- Fresh Fruits, Vegetables and Dates.
- Grains and Materials used as fodder for animals such as Barley, Durra, Millets, Soya Beans, Hay, Dried Clovers and Straw of all types.
- All Agricultural Pesticide and Dry and Liquid Chemical Manures.
- The Minister of Industry and Electricity shall issue the necessary resolution in relation to chemicals (other than dangerous explosives and chemicals that need a license from the Ministry of Health) imported by National Factories.
- The Minister of Commerce shall issue the necessary resolution in relation to all other imported commodities which were not mentioned in the previous paragraphs of this Article.
The Competent Ministry shall issue a resolution to determine the commodities which are to be tested by the private laboratory before sixty days from entrusting the assignment to the private laboratory and after advertising them in the Official Gazette provided that the Ministry of Commerce and the Ministry of Finance and National Economy (Customs Department) are informed of that.
The owner of the commodities shall not dispose of them except after the final result of the test is announced and he is informed by the competent authority.
Seeking assistance from the Private Laboratories for the purpose of testing commodities produced locally and imported
The Competent Minister shall issue, in case of need, the necessary resolution to seek assistance from private laboratories which are approved and licensed for the purpose of testing commodities produced or manufactured locally or imported commodities that are displayed in the markets or stored in warehouses or in factories in accordance with the control authorities entrusted to his Ministry.
Obligations and Duties of the Laboratory
The Private Licensed Laboratory undertakes as follows :
- To make all tests required by the approved standard specifications relating to the commodities which it is licensed to test unless the competent authority specified the type of tests required.
- Application of the approved standard specifications of the commodity referred to it.
- Application of the method of test mentioned in the approved standard specifications of the commodity referred to it.
- To confine the tests to the commodities mentioned in the license only.
- To have an office in the Customs Area representing the laboratory whose assistant is sought for the purpose of Customs Clearance.
- To observe the professional standard of performance and accuracy in accordance with the basic principles of the profession in relation to the test with honesty, sincerity and impartiality, observing the confidentiality of the work and the safety of the equipments.
- Keeping the records of the results of the tests for a period of not less than five years for reference purpose in case of need.
- Putting the License, the organizational framework, the technical sections, the cost of tests and the certificate of approval issued by the authority in a prominent place on the entrance of the laboratory.
- To observe confidentiality when transmitting the sample and the results of tests and not to give any information except to the competent authorized persons only.
- To observe the rules of fair competition.
The Private License Laboratory may - after the consent of the Competent Ministry is obtained - seek the assistance of other private licensed laboratories to make some tests when some of the tests are outside the scope of its specialization without prejudice to their joint responsibility.
Taking of Samples
The imported sample shall be taken to be tested for the purpose Customs Clearance by technicians from the Ministries of Interior, Agriculture, Commerce or Industry or their authorized representatives each in his specialty as provided in paragraphs (a), (b), (c) and (d) of Article Eleven.
The sample from the commodities offered in the markets, stored in warehouses or from factories shall be taken for the purpose of testing by technical Inspectors from the Competent Ministry each in his specialty.
The sample shall be taken on scientific basis in accordance with the approved standard specifications.
The technicians of the Competent Ministry shall deliver the sample of the imported consignment after it is made ready to the office representing the Laboratory within twenty four hours from the time of taking it, attaching with it the approved form for referring the sample to testing after filling all information and mentioning the required tests.
Article Twenty One:
The office representing the laboratory undertakes to transmit the sample of the imported consignment to the laboratory by proper scientific methods according to its type within twenty four hours from receiving it.
Article Twenty Two:
The technical inspector of the competent authorities shall deliver the sample taken from the markets, factories or warehouses to the laboratory or the representative office of the laboratory directly attaching with it the approved form of referral of the sample to testing after filling all information and mentioning the required tests.
Article Twenty Three:
The technicians of the Competent Ministry undertake to distribute the samples equally and in a regular and organized manner among the laboratories in case there is more than one laboratory for a certain commodity in accordance with clear and specified schedules which may easily be referred to, taking into consideration - that the laboratories specialized in more than one field represent an independent laboratory in each field.
Article Twenty Four:
The Laboratory undertake to deliver the results of the test with the remainder of the sample or evidence proving that it was used up during the test to the place from which it was received within fifteen days from the date of receipt provided that, that place informs the Competent Ministry and the owner of the commodity of the results of the test within a period of not more than twenty five days from the date of taking the sample.
Article Twenty Five:
The owner of the sample required to be tested shall pay all the financial cost involved in advance.
Article Twenty Six:
The owner of the sample that failed to pass the test may object to the result before the Competent Ministry within ten days from the date on which he was informed of the result.
Classification of Laboratories
Article Twenty Seven:
The laboratories shall be classified into Ten Main Sectors which are:
- First: Foods and Agricultural Materials Laboratories.
- Second: Pharmaceuticals and Biological Preparations Laboratories.
- Third: Herbs and Medical Plants, Sanitary Preparations and Cosmetic Laboratories.
- Fourth: Chemical and Petroleum Substances Laboratories.
- Fifth: Electrical and Electronic Products Laboratories.
- Sixth: Mechanical and Mineral Products, Laboratories.
- Seventh: Construction and Building Materials Laboratories.
- Eighth: General Materials such as Plastic, Rubber, wood and Paper Products Laboratories.
- Ninth: Textile and Spinning Products Laboratories.
- Tenth: Measure, Standard and Verification Laboratories.
Supervision of Laboratories
Article Twenty Eight:
Checking and investigation of violations of the law and its Implementing Regulations shall be entrusted to the employees of the Competent Ministry whether jointly or severally and shall be appointed in accordance with a resolution of the Competent Minister.
Article Twenty Nine:
Any of the employees referred to in the previous Article may, in order to discharge their duties, may exercise the following acts:
- Entering the Laboratories governed by the provisions of the law licensed or not licensed and the warehouses, rooms and places where samples are stored and kept which are attached to the laboratory whether these places are assigned to this purpose or parts of them are used as residential and the like and take samples.
- Supervising the employees working in the laboratory.
- Keeping on reservation the samples, equipments, violating equipments or equipments suspected to be violating and the documents relating to them and in all cases the investigation of the violations and taking of samples for testing, attachment of commodities or equipments and reservation of equipments shall be in accordance with formal minutes, provided that the investigation minutes shall include the name of the violator, date and place of investigation, type of violation, statement of the things investigated, their state and weight if possible provided that the minutes are signed by each of the investigator, the owner of the laboratory or its manager or the person in-charge of the employees or one of the employees in the place of investigation and if he refuses to sign that shall be stated in the minutes.
The investigation officers shall observe confidentiality and good conduct and shall submit to the person concerned a proof of their identity and their official capacity and the purpose of the visit.
Article Thirty One:
The investigation officers shall conduct the investigation procedures by summoning the violator and those required for investigation and face them with the violation and the evidence available against him and give him the opportunity if he requested to submit his comments in writing and raise his defenses and examine the defense provided that the violator sign each reply and the investigation officer as soon as the investigation is completed shall prepare a statement of the facts of the case and the file shall be referred to the competent department to institute the penal suite provided that the said department shall inform the Authority of the result of the investigation.
Article Thirty Two:
The investigation officers may seek the assistance of the Security authorities in case the owner of the laboratory or one of the employees refuses to enable the competent officers from performing their duties.
Article Thirty Three:
The competent department determined by the Competent Minister shall institute the penal suite and follow-up its proceedings and represent the public right before the Board of Grievance and may in this respect appoint a general prosecutor to initiate the suits and represent the public right therein.
Article Thirty Four:
The provisions of the law shall apply to all private laboratories prepared for the purpose of testing commodities provided that the private laboratories existing before the coming into force of the provisions of this law shall be given a period of two years from the date of its effectiveness to modify their positions to obtain the required license.
Article Thirty Five:
A Licensee to operate a laboratory shall not assign the license or terminate the activity finally unless the consent of the Competent Ministry is obtained.
Article Thirty Six:
The Competent Ministry shall provide the Ministry of Commerce with copies of the licenses and any amendment thereof.
Article Thirty Seven:
The Competent Minister shall constitute the Competent Committee referred to in paragraph "b" of Article Seven to study the maximum cost of the tests provided by the applicant of the license and issue the necessary recommendation.
Article Thirty Eight:
This Implementing Regulation shall be published in the Official Gazette and shall come into force from the date of publication.
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