1-1 Names and Types of Chemical Substances: These are all chemical substances in their gaseous, liquid, solid, aqueous, or non-aqueous states that are listed in locally or internationally recognized classified scientific references, including prohibited and restricted substances listed in the annexed lists to this Regulation, as follows:

• 1- First List: It includes hazardous chemical substances used in the composition of explosives.

• 2- Second List: It includes chemical precursors used in the manufacture of narcotics and psychotropic substances.

• 3- Third List: It includes some chemical substances used in the composition of explosives and chemical precursors used in the manufacture of narcotics and psychotropic substances.

• 4- Fourth List: It includes:

  • A- Chemical substances prohibited or restricted under the Rotterdam Convention of 1998 concerning the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, and this list is subject to the instructions issued by the Ministry of Environment, Water, and Agriculture (National Center for Environmental Compliance).

  • B- Chemical substances prohibited under the Minamata Convention on Mercury of 2017, and this list is subject to the instructions issued by the Ministry of Environment, Water, and Agriculture (National Center for Environmental Compliance).

• 5- Fifth List: It includes chemical substances prohibited or restricted under the Stockholm Convention of 2001 concerning Persistent Organic Pollutants, and this list is subject to the instructions issued by the Ministry of Environment, Water, and Agriculture (National Center for Environmental Compliance).

• 6- Sixth List: It includes chemical substances prohibited or restricted under the Montreal Protocol of 1987 for the prohibition of substances that deplete the ozone layer, and this list is subject to the instructions issued by the Ministry of Environment, Water, and Agriculture (National Center for Environmental Compliance).

• 7- Seventh List: The procedures for their clearance and import are governed according to the Law Implementing the Convention on the Prohibition of the Development, Production, Stockpiling, and Use of Chemical Weapons and Their Destruction issued byRoyal Decree No. M/57 dated 26/10/1426 AH, and its executive regulations, and this list is subject to the instructions issued by the Ministry of Foreign Affairs.

• 8- Eighth List: It includes explosives intended for civilian use under theLaw of Explosives and Fireworks issued byRoyal Decree No. M/38 dated 28/4/1428 AH, and its executive regulations, and this list is subject to the instructions issued by the Ministry of Interior.

• 9- Ninth List: It includes chemical substances that are not restricted or prohibited internationally in the lists mentioned above.

1-2 Accumulated Chemical Substances:

Chemical substances are considered accumulated in the following cases:

• 1- If they exceed the needs of the importing or dealing entity.

• 2- Expiration of their validity period or no longer needed.

• 3- If their clearance and release procedures at land, air, or sea ports are not completed and they remain for more than ten working days from the date of their arrival at those ports.

2- 1‏-1 Procedures for Requesting the Issuance of a Permit to Import Chemical Materials Used in the Composition of Explosives Listed (in the First List):

First: Submit an application to the authority responsible for practicing the activity - according to the purpose of importing the chemical materials - with a letter including a request for a permit to import chemical materials used in the composition of explosives, accompanied by the following:

• A- Application form for a permit to import chemical materials used in the composition of explosives, Form No. (1).

• B- A valid copy of the Commercial Register or a copy of the industrial license.

• C- A valid copy of the Civil Defense license indicating that the chemical materials warehouses meet the requirements for fire prevention and protection and are subject to preventive supervision, or a document proving Civil Defense approval for governmental entities.

• D- A valid copy of the license issued by the Higher Industrial Security Authority indicating that the chemical materials warehouses of petroleum, industrial, and service facilities subject to the supervision of the Higher Industrial Security Authority meet the requirements of security, safety, and fire protection.

• E- A copy of the operating license issued by the supervisory authorities for facilities not subject to the supervision of the Higher Industrial Security Authority or preventive supervision in Civil Defense, in case the facility falls within the supervisory scope of these authorities.

• F- A pledge from the entity requesting the import permit (company, institution, or factory) in the format attached to Form No. (2).

• G- The person responsible for the chemical materials warehouse must be a Saudi national holding a bachelor's degree in chemical engineering, chemistry, pharmacy, medical devices, medical laboratories, or be a chemical technician, pharmaceutical technician, medical devices technician, or medical laboratories technician. Regarding entities operating in agricultural activities, it is permissible to appoint a warehouse manager specialized in agriculture; or be a Saudi national holding at least a high school diploma, having completed hazardous materials handling courses of no less than three months, and possessing experience in handling chemical materials and their storage methods, as a minimum requirement.

• H- The person responsible for the chemical materials warehouse must be an employee of the same entity requesting the import permit.

Second: The authority responsible for practicing the activity shall study the application and provide opinions regarding the type of chemical materials to be imported, the quantity, and the purpose of import within a maximum period of five working days from the date of submitting a complete application. Upon approval, the application shall be officially referred to the competent authority at the Ministry of Interior (Higher Industrial Security Authority). If the application is not approved, it shall be returned to the applicant with justifications for the rejection.

Third: The competent authority at the Ministry of Interior (Higher Industrial Security Authority) shall study the application and complete its procedures within a maximum of five working days from the date of receipt and shall do the following:

• 1- Issue an import permit according to Form No. (3) and deliver it to the applicant.

• 2- Retain a copy of the import permit.

• 3- Provide the authority responsible for practicing the activity with a copy of the permit upon their request.

2-1-2 Procedures for Requesting the Issuance of a Permit to Import Chemical Precursors Used in the Manufacture of Narcotics and Psychotropic Substances Listed (in the Second List):

First: Submit an application to the authority responsible for practicing the activity - according to the purpose of importing the chemical materials - with a letter including a request for a permit to import chemical precursors, accompanied by the application form for a permit to import chemical precursors according to Form No. (4) and the requirements (B, C, D, E, F, G, H) from (First) of item No. (2-1-1) mentioned above.

Second: The authority responsible for practicing the activity shall study the application and provide opinions regarding the type of chemical materials to be imported, the quantity, and the purpose of import within a maximum period of five working days from the date of submitting a complete application. Upon approval, the application shall be officially referred to the Ministry of Interior (General Directorate for Narcotics Control - General Department of Precursors and Laboratories).

Third: The Ministry of Interior (General Directorate for Narcotics Control - General Department of Precursors and Laboratories) shall study the application and complete its procedures within a maximum of five working days from the date of receipt. Upon approval, it shall be officially referred to the competent authority (Saudi Food and Drug Authority). In case of rejection, the application shall be returned to the referring authority with justifications for the rejection.

Fourth: The competent authority (Saudi Food and Drug Authority) shall study the application and complete its procedures within a maximum of five working days from the date of receipt and shall do the following:

• 1- Issue an import permit according to Form No. (5) and deliver it to the applicant.

• 2- Provide the Ministry of Interior (General Directorate for Narcotics Control - General Department of Precursors and Laboratories) and (Higher Industrial Security Authority) with a copy of the import permit.

• 3- Retain a copy of the import permit.

• 4- In case of rejection, the application shall be returned to the authority responsible for the activity with justifications for the rejection, along with a certified copy to the Ministry of Interior (General Directorate for Narcotics Control - General Department of Precursors and Laboratories).

2-1-3 Procedures for Requesting the Issuance of a Permit to Import Chemical Materials Used in the Composition of Explosives and Chemical Precursors Used in the Manufacture of Narcotics and Psychotropic Substances Listed (in the Third List):

First: Submit an application to the authority responsible for the activity - according to the purpose of importing the chemical materials - with a letter including a request for a permit to import chemical materials used in the composition of explosives and the manufacture of narcotics and psychotropic substances according to Form No. (6) and the requirements (B, C, D, E, F, G, H) from (First) of item No. (2-1-1) mentioned above.

Second: The authority responsible for practicing the activity shall study the application and provide opinions regarding the type of chemical materials to be imported, the quantity, and the purpose of import within a maximum period of five working days from the date of submitting a complete application. Upon approval, the application shall be officially referred to the Ministry of Interior (General Directorate for Narcotics Control - General Department of Precursors and Laboratories). If the application is not approved, it shall be returned to the applicant with justifications for the rejection.

Third: The Ministry of Interior (General Directorate for Narcotics Control - General Department of Precursors and Laboratories) shall study the application and complete its procedures within a maximum of five working days from the date of receipt. Upon approval, the application shall be referred to the competent authority at the Ministry of Interior (Higher Industrial Security Authority). In case of rejection, the application shall be returned to the referring authority with justifications for the rejection and a certified copy to the Higher Industrial Security Authority.

Fourth: The competent authority at the Ministry of Interior (Higher Industrial Security Authority) shall study the application and complete its procedures within a maximum of five working days from the date of receipt and shall do the following:

• 1- Approve the import of these materials according to Form No. (7) and deliver it to the applicant.

• 2- Notify the Ministry of Interior (General Directorate for Narcotics Control - General Department of Precursors and Laboratories) of the approval of the import.

• 3- Notify the Saudi Food and Drug Authority of the approval of the import.

• 4- Retain a copy of the import approval.

• 5- In case of rejection, the application shall be returned to the authority responsible for the activity with justifications for the rejection, along with a certified copy to the Ministry of Interior (General Directorate for Narcotics Control - General Department of Precursors and Laboratories).

2-1-4 Procedures for Requesting the Issuance of a Permit to Import Unrestricted or Internationally Unprohibited Chemical Materials (Ninth List):

First: Submit an application to the competent authority according to the purpose of importing the chemical materials with a letter including a request for a permit to import chemical materials accompanied by the application form for a permit to import unrestricted or internationally unprohibited chemical materials according to Form No. (8) and the requirements (B, C, D, E, F, G, H) from (First) of item No. (2-1-1) mentioned above.

Second: The competent authority shall study the application within no more than five working days from the date of submitting a complete application. In case of approval, it shall do the following:

• 1- Issue an import permit or its equivalent from the competent authority, such as the industrial license or commercial register including the activity of trading chemical materials, or issue it according to Form No. (9) and deliver it to the applicant.

• 2- Retain a copy of the import permit.

2-2 Conditions of the Import Permit:

1- The license to practice the activity for the importing entity must be valid.

2- Compliance with the conditions and specifications for transporting and shipping chemical materials determined by the manufacturing company, and the conditions stipulated in international agreements, regulations, laws, and specifications applicable in the Kingdom.

3- Compliance with the instructions of the import permit specified by the competent authority.

4- It is permissible to import the chemical materials listed in the import permit in several batches, for all or some of the items. If the chemical material listed in the Ninth List is classified as a medical device or medical supply, the import permit is granted according to the shipment only if the purpose of import is one of the following cases:

• A- General emergencies such as natural disasters, wars, or epidemics.

• B- Personal use according to the requirements of the competent authority.

• C- Research or educational uses.

• D- Pre-marketing clinical studies approved by the competent authority for the study.

• E- If manufactured on demand for a specific patient, based on the request of the treating team.

• F- If classified by the competent authority as samples of medical devices or supplies used in exhibitions, festivals, or workshops.

2-3 Duration of the Import Permit: One Gregorian year except for the Ninth List, which is five years from the date of issuance of the import permit unless a decision is issued to ban or restrict the chemical material.

2-4 Renewal of the Import Permit:

1- The import permit may be renewed whether part of the quantity was imported or not, up to a maximum of three times in the following cases:

• A- In case of modification or change of the importing entity's data or the manufacturing or exporting company.

• B- In case of modification or change of information or quantities of the imported chemical materials.

• C- In case of replacement or change of the importing entity or its data.

2- The beneficiary entity must submit a renewal request for the remaining quantities to the authority responsible for practicing the activity, which shall be treated according to the procedures followed in issuing a new import permit, accompanied by justifications for the renewal, provided that a copy of the previous import permit is presented.

2-5 The import permit shall be canceled in the following cases:

1- If the import permit is subjected to any erasure, modification, addition, or deletion.

2- If the cleared materials are used for purposes other than those for which they were imported.

3- If the beneficiary or importing entity is prohibited from importing chemical materials.

4- In case of modification or change of the data or activity of the importing entity.

2-6 Procedures for Requesting an Import Clearance Permit for Chemical Materials:

2-6-1 Chemical materials shall not be cleared by customs ports except pursuant to a clearance permit issued by the competent authority.

2-6-2 Procedures, Forms, and Conditions for Requesting an Import Clearance Permit:

• A- The importer who has obtained an import permit for chemical materials must submit to the competent authority granting the import permit a letter requesting an import clearance permit for each imported shipment at least ten working days before the actual arrival date of the shipment, accompanied by the following:

  • 1- Import Clearance Permit Request Form for Chemical Materials, Form No. (10), after filling in all its fields.

  • 2- A copy of the valid import permit.

  • 3- A clear copy of the purchase invoice including the invoice number and date, the name and address of the manufacturing and exporting company, the scientific and commercial names of the chemical materials, and their quantities, in clear and legible handwriting in either Arabic or English.

  • 4- The Zakat, Tax, and Customs Authority must verify the country of export of the chemical materials arriving through customs ports based on the information available on the shipment or the certificate of origin related thereto.

  • 5- A clear copy of the Safety Data Sheet (SDS) for the imported chemical materials in English, stamped with the importer’s seal, provided that the validity of this sheet does not exceed three years or when modifications are made to the chemical materials to be imported.

  • 6- Consideration of medical products containing restricted materials that do not have a safety data sheet according to internationally recognized customs, after the Saudi Food and Drug Authority certifies the purchase invoice.

  • 7- Disclosure Form of the establishment’s warehouse data according to Form No. (13), to be submitted once at the first clearance.

• B- The competent authority shall undertake the following:

  • 1- Complete the procedures for requesting and issuing the import clearance permit and approve it within five working days from the date of submission, issuing Clearance Permit Form No. (11).

  • 2- Send the clearance permit to the Zakat, Tax, and Customs Authority.

  • 3- Retain a copy of the import clearance permit.

  • 4- Provide the National Center for Environmental Compliance with a copy of the issued clearance permit.

  • 5- Provide the Plant Production Department at the Ministry of Environment, Water, and Agriculture with a copy of the issued clearance permit for importing chemical materials listed in the first annex attached to this regulation for agricultural companies and institutions.

  • 6- Provide the Ministry of Interior (General Directorate of Public Security – General Directorate of Civil Defense – Higher Industrial Security Authority) with a copy of the issued clearance permit.

  • 7- Provide the Ministry of Interior (General Directorate for Narcotics Control – General Directorate of Precursors and Laboratories) with a copy of the issued clearance permit for importing chemical materials listed in the second and third annexes attached to this regulation.

  • 8- Provide the Saudi Food and Drug Authority with a copy of the issued clearance permit for importing chemical materials listed in the third annex attached to this regulation.

• C- The Zakat, Tax, and Customs Authority shall provide the Saudi Food and Drug Authority and the Ministry of Interior (Higher Industrial Security Authority) with the actual imports of chemical precursors listed in the second and third annexes upon their request, including the names of the importers of those materials.

2-6-3 Conditions for Issuing an Import Clearance Permit for Chemical Materials:

1- The issuance of an import clearance permit requires a valid import permit issued by the competent authority.

2- Compliance with the conditions and specifications for transporting and shipping chemical materials as determined by the manufacturing company, and the conditions stipulated in international agreements, applicable laws, and executive regulations in the Kingdom.

3- Compliance with the instructions of the clearance permit as specified by the competent authority.

4- Compliance with the safety requirements set forth in Annex No. (3).

5- For establishments subject to the supervision of the Higher Industrial Security Authority, compliance with the security instructions (SEC) and fire safety and protection instructions (SAF) issued by the Authority regarding the requirements, conditions, and instructions for chemical material storage warehouses is mandatory.

2-6-4 Duration of the Import Clearance Permit for Chemical Materials:

The validity period of the chemical materials clearance permit shall be one full Gregorian year.

2-6-5 Renewal of the Import Clearance Permit for Chemical Materials:

1- Submit a request to renew the chemical materials clearance permit to the competent authority to renew it once in case of loss, unintentional damage, expiration, or change of port of entry.

2- The competent authority shall officially notify the Zakat, Tax, and Customs Authority of the cancellation of the previous import clearance permit and approve the new chemical materials import clearance permit.

2-6-6 Cancellation of the Import Clearance Permit for Chemical Materials:

The chemical materials clearance permit shall be canceled in the following cases:

1- The competent authority prevents the importing party from importing the chemical materials.

2- If the names, data, types, conditions, and forms of the imported chemical materials differ from those stated in the import permit, or if the imported materials were not originally listed in the import permit.

3- If the actual imported quantity or number exceeds that specified in the import permit.

2-7 Export Permit Application Procedures.

2-7-1 Procedures for Applying for an Export Permit for Chemical Substances Used in Explosives Composition (First List):

First: Submit to the authority responsible for practicing the activity a letter including a request for an export permit for chemical substances used in explosives composition, accompanied by the following:

• A- Export permit application form for chemical substances used in explosives composition, Form No. (12).

• B- A valid copy of the Commercial Register or a copy of the industrial license or both.

• C- A valid copy of the Civil Defense license indicating that the chemical warehouses meet the fire prevention and protection requirements and are subject to preventive supervision, or a document proving Civil Defense approval for governmental entities.

• D- A valid copy of the license issued by the Higher Industrial Security Authority indicating that the chemical warehouses of petroleum, industrial, and service facilities subject to the supervision of the Higher Industrial Security Authority meet the security, safety, and fire protection requirements.

• E- A copy of the operating license issued by the supervisory authorities for facilities not subject to the supervision of the Higher Industrial Security Authority or preventive supervision in Civil Defense, if the facility falls within the supervisory scope of these authorities.

• F- Medical devices and food and drug activity license issued by the Saudi Food and Drug Authority.

• G- A pledge from the entity requesting the export permit (whether a company, institution, or factory) in the format attached to Form No. (14).

• H- The person responsible for the chemical warehouse must be a Saudi national holding a bachelor's degree in chemical engineering, chemistry, pharmacy, medical devices, medical laboratories, or be a chemical technician, pharmaceutical technician, medical devices technician, or medical laboratories technician. For entities operating in agricultural activities, it is permissible to appoint a chemical warehouse manager specialized in agriculture; or be a Saudi national holding at least a high school diploma, having completed hazardous materials handling courses of no less than three months, and possessing experience in handling chemical substances and their storage methods, as a minimum requirement.

• I- The person responsible for the chemical warehouse must be an employee of the same entity requesting the export permit.

• J- Attach Safety Data Sheets (SDS) for the materials listed in Form (12) from the manufacturer, provided that the issue or revision date of the sheet does not exceed three years or when modifications are made to the chemical substances intended for export.

Second: The authority responsible for practicing the activity shall study the application and provide opinions regarding the type of chemical substances to be exported, the quantity, and the purpose of export within a maximum period of five working days from the date of submitting a complete application. Upon approval, the application shall be officially referred to the competent authority at the Ministry of Interior (Higher Industrial Security Authority). If not approved, it shall be returned to the applicant with justifications for the rejection.

Third: The competent authority at the Ministry of Interior (Higher Industrial Security Authority) shall study the application and complete its procedures within a maximum of five working days from the date of receipt of the transaction and shall do the following:

• 1- Issue the export permit according to Form No. (15) and deliver it to the applicant.

• 2- Retain a copy of the export permit.

• 3- Provide the authority responsible for practicing the activity with a copy of the export permit upon their request.

2-7-2 Procedures for Applying for an Export Permit for Chemical Precursors Used in the Manufacture of Narcotics and Psychotropic Substances (Second List) as follows:

First: Submit to the authority responsible for practicing the activity a letter including a request for an export permit for chemical precursors used in the manufacture of narcotics and psychotropic substances (Second List) according to Form No. (16) and requirements (B, C, D, E, F, G, H, I, J) from (First) of item No. (2-7-1) mentioned above.

Second: The authority responsible for practicing the activity shall study the application and provide opinions regarding the type of chemical substances to be exported, the quantity, and the purpose of export within a maximum period of five working days from the date of submitting a complete application. Upon approval, the application shall be officially referred to the Ministry of Interior (General Directorate of Narcotics Control - General Department of Precursors and Laboratories). If not approved, it shall be returned to the applicant with justifications for the rejection.

Third: The Ministry of Interior (General Directorate of Narcotics Control - General Department of Precursors and Laboratories) shall study the application and complete its procedures within a maximum of five working days from the date of receipt of the transaction. If approved, the application shall be referred to the competent authority (Saudi Food and Drug Authority). If not approved, the application shall be returned to the authority responsible for practicing the activity with justifications for the rejection.

Fourth: The competent authority (Saudi Food and Drug Authority) shall study the application and complete its procedures within a maximum of five working days from the date of receipt of the transaction and shall do the following:

• 1- Issue the export permit according to Form No. (17) and deliver it to the applicant.

• 2- Provide the Ministry of Interior (General Directorate of Narcotics Control - General Department of Chemical Precursors and Laboratories) with a copy of the export permit.

• 3- Provide the Ministry of Interior (Higher Industrial Security Authority) with a copy of the export permit.

• 4- Retain a copy of the export permit.

• 5- In case of rejection, the application shall be returned to the authority responsible for practicing the activity with justifications for the rejection, along with a certified copy to the Ministry of Interior (General Directorate of Narcotics Control - General Department of Precursors and Laboratories).

2-7-3 Procedures for Applying for an Export Permit for Chemical Substances Used in Explosives Composition and Chemical Precursors Used in the Manufacture of Narcotics and Psychotropic Substances (Third List):

First: Submit to the authority responsible for practicing the activity a letter including a request for an export permit for chemical substances used in explosives composition and the manufacture of narcotics and psychotropic substances according to Form No. (18) and requirements

(B, C, D, E, F, G, H, I, J) from (First) of item No. (2-7-1) mentioned above.

Second: The authority responsible for practicing the activity shall study the application and provide opinions regarding the type of chemical substances to be exported, the quantity, and the purpose of export within a maximum period of five working days from the date of submitting a complete application. Upon approval, the application shall be officially referred to the Ministry of Interior (General Directorate of Narcotics Control - General Department of Precursors and Laboratories). If not approved, it shall be returned to the applicant with justifications for the rejection.

Third: The Ministry of Interior (General Directorate of Narcotics Control - General Department of Precursors) shall study the application and complete its procedures within a maximum of five working days from the date of receipt of the transaction. If approved, the application shall be referred to the competent authority at the Ministry of Interior (Higher Industrial Security Authority). If not approved, the application shall be returned to the authority responsible for practicing the activity with justifications for the rejection and a certified copy to the Higher Industrial Security Authority.

Fourth: The competent authority at the Ministry of Interior (Higher Industrial Security Authority) shall study the application and complete its procedures within a maximum of five working days from the date of receipt of the transaction and shall do the following:

• 1- Approve the export of these materials according to Form No. (19) and deliver it to the applicant.

• 2- Notify the Ministry of Interior (General Directorate of Narcotics Control - General Department of Precursors and Laboratories) with a copy of the approval of the export permit.

• 3- Notify the Saudi Food and Drug Authority with a copy of the approval of the export permit.

• 4- Retain a copy of the approval of the export permit.

• 5- In case of rejection, the application shall be returned to the authority responsible for practicing the activity with justifications for the rejection, along with a certified copy to the Ministry of Interior (General Directorate of Narcotics Control - General Department of Precursors and Laboratories).

2-7-4 Procedures for Applying for an Export Permit for Unrestricted or Internationally Uncontrolled Chemical Substances (Ninth List):

First: Submit to the authority responsible for practicing the activity a letter including a request for an export permit for unrestricted or internationally uncontrolled chemical substances, accompanied by Form No. (20) and requirements (B, C, D, E, F, G, H, I, J) from (First) of item No. (2-7-1) mentioned above.

Second: The authority responsible for practicing the activity shall study the application within a maximum period of five working days from the date of submitting a complete application. In case of approval, it shall do the following:

1- Issue the export permit or its equivalent from the competent authority, such as the industrial license or commercial register including the activity of trading chemical substances, or issue it according to Form No. (21) and deliver it to the applicant.

2-8 Conditions of the Export Permit:

1- The activity license of the exporting entity must be valid.

2- Compliance with the conditions and specifications for transporting and shipping chemical substances as determined by the manufacturing company, and the conditions stipulated in international agreements, laws, regulations, and standards applicable in the Kingdom.

3- Compliance with the instructions of the export permit as determined by the competent authority.

4- It is permissible to export the chemical substances listed in the export permit in several batches, for all or some of the items.

2-9 Duration of the Export Permit: Three Gregorian years from the date of issuance of the export permit, and five Gregorian years for the ninth list unless a decision is issued to ban or restrict the chemical substance.

2-10 Renewal of the Export Permit:

1- The export permit shall be renewed whether part of the quantity was exported or not, once during each Gregorian year in the following cases:

• A- In case of modification or change of the data of the exporting entity or the manufacturing company.

• B- In case of modification or change of the information or quantities of the exported chemical substances.

2- The beneficiary entity shall submit a renewal request for the remaining quantities to the authority responsible for practicing the activity, and it shall be treated according to the procedures followed in issuing a new export permit, accompanied by justifications for the renewal, provided that a copy of the previous permit is presented.

2-11 Procedures for Requesting Export Clearance Permit for Chemical Materials:

2-11-1 Chemical materials shall not be exported through customs ports except pursuant to an export clearance permit issued by the competent authority.

2-11-2 Procedures, Forms, and Conditions for Requesting Export Clearance Permit for Lists (First, Second, and Third):

• A- The exporter who has obtained an export permit for chemical materials must submit to the competent authority granting the export permit a letter requesting an export clearance permit for each exported shipment at least ten working days before the actual export date of the shipment, accompanied by the following:

  • 1- Export clearance permit request form for chemical materials, Form No. (22), after filling in all its fields.

  • 2- A copy of a valid export permit.

  • 3- A clear copy of the sales invoice including the invoice number and date, the name and address of the manufacturing and exporting company, the scientific and commercial names of the chemical materials, and their quantities, in clear and legible Arabic or English.

  • 4- Compliance with medical products containing restricted materials that do not have a safety data sheet according to the applicable international custom, after the Saudi Food and Drug Authority certifies the purchase invoice.

  • 5- Disclosure form of the establishment's warehouse data according to Form No. (13), to be submitted once at the first clearance.

• B- The competent authority shall undertake the following:

  • 1- If the materials are within the second and third lists (mentioned in this regulation), notify (the General Directorate of Narcotics Control - General Department of Precursors and Laboratories) immediately upon receipt of the export clearance permit request.

    • 1-1 The Ministry of Interior (General Directorate of Narcotics Control - General Department of Precursors and Laboratories) shall study the request and notify the importing country to obtain its approval to receive the shipment through the Pre-Export Notification system of the International Narcotics Control Board (PEN Online).

    • 1-2 The competent authority shall be officially informed by letter in case of the importing country's approval or rejection, accompanied by reasons for rejection.

  • 2- Complete the procedures for obtaining the export clearance permit and issue and approve it if the request and its attachments are complete within three working days from the date of submission, and issue the export clearance permit according to Form No. (23).

  • 3- Send the export clearance permit to the Zakat, Tax, and Customs Authority.

  • 4- Retain a copy of the export clearance permit.

  • 5- Provide the National Center for Environmental Compliance with a copy of the export clearance permit.

  • 6- Provide the Ministry of Interior (General Directorate of Public Security - General Directorate of Civil Defense) with a copy of the export clearance permit.

  • 7- Provide the Ministry of Interior (General Directorate of Narcotics Control - General Department of Precursors and Laboratories) with a copy of the export clearance permit for the third list.

• C- The Zakat, Tax, and Customs Authority shall provide the Saudi Food and Drug Authority and the Ministry of Interior (Higher Industrial Security Authority) with the actual quantities exported of the chemical precursors listed in the second and third lists upon their request, including the names of the exporters of those materials.

2-11-3 Conditions for Issuing Export Clearance Permit for Chemical Materials:

Issuance of the export clearance permit requires a valid export permit issued by the competent authority.

1- Compliance with the conditions and specifications for transporting and shipping chemical materials determined by the manufacturing company, and the conditions stipulated in international agreements, applicable laws, and executive regulations in the Kingdom.

2- Compliance with the instructions of the export clearance permit as determined by the competent authority.

3- Compliance with the safety requirements set forth in Annex No. (3).

4- For establishments under the supervision of the Higher Industrial Security Authority, compliance with the security instructions (SEC) and fire safety and protection instructions (SAF) issued by the Authority regarding the requirements, conditions, and instructions for chemical materials storage warehouses is mandatory.

2-11-4 Duration of the Export Clearance Permit for Chemical Materials:

The validity period of the export clearance permit for chemical materials shall be one full Gregorian year.

2-11-5 Renewal of the Export Clearance Permit for Chemical Materials:

1- Submit a request to renew the export clearance permit for chemical materials to the competent authority to renew it once

in case of expiration or change of the export port.

2- The competent authority shall officially notify the Zakat, Tax, and Customs Authority of the cancellation of the previous export clearance permit and approve the new export clearance permit for chemical materials.

3- The Higher Industrial Security Authority shall notify the Saudi Food and Drug Authority of the cancellation of the previous export clearance permit and approve the new export clearance permit for chemical materials for the first and third lists for requests received from them.

2-11-6 Cancellation of the Export Clearance Permit for Chemical Materials:

The export clearance permit for chemical materials shall be canceled in the following cases:

1- Loss or damage of the export permit for chemical materials, expiration of its validity, or a request for its cancellation.

2- The competent authority prevents the exporting party from exporting the chemical materials.

3- If the names, data, types, conditions, and forms of the exported chemical materials differ from those stated in the export permit, or if the materials originally specified in the export permit are not exported.

4- If the actual exported quantity or number exceeds that required in the export permit.

2-12 Procedures for Requesting Re-export Permit and Clearance Permit for Chemical Materials:

2-12-1 It is sufficient to submit the import permit for the materials intended to be re-exported to the competent authority as per the system.

2-12-2 Re-export clearance of chemical materials by customs ports shall only be granted pursuant to a re-export clearance permit issued by the competent authority.

2-12-3 Procedures, Forms, and Conditions for Requesting a Re-export Clearance Permit:

Submit to the competent authority a letter including a request for obtaining a re-export clearance permit accompanied by the following:

• 1- Chemical Materials Re-export Permit Request Form No. (24) after filling in all its fields.

• 2- Attach a copy of the valid commercial registration or industrial license.

• 3- Attach a copy of the valid carrier license if entering the Kingdom through customs ports.

• 4- The Zakat, Tax, and Customs Authority shall verify the country of the importer of the re-exported chemical materials through customs ports based on the information available on the documents.

• 5- Attach Safety Data Sheets (SDS) for the materials listed in Form (24) from the manufacturer, provided that the issue or revision date of the sheet does not exceed three years or when amendments are made to the chemical materials intended for re-export.

• 6- Consideration of medical products containing restricted materials for which no safety data sheet is issued according to internationally recognized practice, after the Saudi Food and Drug Authority approves the purchase invoice.

  • A- The competent authority shall undertake the following:

    • 1- Take the opinion of the authority responsible for practicing the activity regarding approval or disapproval of re-exporting the materials according to its jurisdiction.

    • 2- Complete the procedures for obtaining the re-export clearance permit, issue and approve it within no more than three working days from the date of submission, and issue Re-export Clearance Permit Form No. (25).

    • 3- Send the re-export permit to the Zakat, Tax, and Customs Authority.

    • 4- Retain a copy of the re-export clearance permit.

    • 5- Provide the National Center for Environmental Compliance with a copy of the re-export clearance permit.

    • 6- Provide the Ministry of Interior (General Directorate of Public Security and General Directorate of Civil Defense) with a copy of the re-export clearance permit.

    • 7- Provide the Ministry of Interior (General Directorate for Narcotics Control – General Directorate of Precursors and Laboratories) with a copy of the re-export clearance permit issued for chemical materials listed in the second and third lists attached to this regulation.

    • 8- Provide the Saudi Food and Drug Authority with a copy of the re-export clearance permit issued for chemical materials listed in the third list attached to this regulation.

  • B- The Zakat, Tax, and Customs Authority shall provide the Saudi Food and Drug Authority and the Ministry of Interior (Higher Industrial Security Authority) with the actual quantities re-exported of the chemical precursors listed in the second and third lists upon their request, including the names of the exporters of those materials.

2-12-4 Cases in which a Re-export Clearance Permit for Chemical Materials is Issued:

1- It is a condition for issuing a re-export clearance permit that the shipment is cleared from the customs port pursuant to a clearance permit issued by the competent authority and the desire to re-export it.

2- The shipment enters the Kingdom through customs ports, is unused, and there is a desire to return it to the supplier for any reason.

2-12-5 Conditions for Issuing a Re-export Clearance Permit:

1- It is a condition for issuing a re-export clearance permit for materials that have entered the Kingdom to have a valid import permit and clearance permit issued by the competent authority.

2- Compliance with the conditions and specifications for transporting and shipping chemical materials as determined by the manufacturing company, and the conditions stipulated in international agreements, applicable laws, and executive regulations in the Kingdom in case of entry through customs ports.

3- Compliance with the instructions of the re-export clearance permit as determined by the competent authority.

2-12-6 Cancellation of the Re-export Clearance Permit for Chemical Materials:

The re-export clearance permit for chemical materials shall be canceled in the following cases:

• 1- When the chemical materials intended for re-export permit issuance are used in manufacturing processes.

• 2- If the names, data, types, conditions, and forms of the re-exported chemical materials differ from those stated in the re-export clearance permit request.

3-1 Providing the importing entities of chemical precursors listed in the second and third lists to the Ministry of Interior (General Directorate of Narcotics Control) at the end of each calendar year with data on the following:

• 1- The quantities imported, consumed, and remaining.

• 2- The quantities produced and remaining.

• 3- The quantities damaged.

• 4- These quantities must be in known weight units (kilogram, gram, ton) or volume (liter, milliliter, cubic meter).

3-2 The Ministry of Interior (General Directorate of Narcotics Control) and the Saudi Food and Drug Authority coordinate to monitor chemical precursors and verify the accuracy of the data referred to in paragraph (3-1) of this regulation.

3-3 The Saudi Food and Drug Authority shall submit the annual report on the permitted quantities to the International Narcotics Control Board (INCB) at the end of each calendar year.

3-4 In all cases, import, export, re-export, and clearance permits for chemical substances related to (the third list) shall not be issued except after obtaining approval for all items from the Ministry of Interior.

3-5 Products classified as medical device accessories are subject to the supervision of the Saudi Food and Drug Authority regardless of the purpose of their importation.

6-1 The Transport General Authority issues licenses for the transport of chemical materials (by land, sea, rail) according to the following:

• A- Chemical materials shall not be transported by land except by a carrier holding a cargo transport license for land routes issued by the Transport General Authority in accordance with the requirements it sets.

• B- Chemical materials shall not be transported by sea except after the carrier obtains a license to practice maritime transport operations and the means of transport with the necessary certificates from the Transport General Authority in accordance with the conditions and requirements it sets, taking into account the relevant international agreements and codes.

• C- Chemical materials shall not be transported by rail except by a carrier holding a rail transport license issued by the Transport General Authority in accordance with the procedures and requirements approved by the Transport General Authority.

6-2 The General Authority of Civil Aviation issues licenses for the transport of chemical materials by air according to the following conditions:

• A- Applying to the General Authority of Civil Aviation with a letter on the official letterhead of the establishment requesting a license to transport chemical materials by air in accordance with the executive regulations of the General Authority of Civil Aviation derived from the Civil Aviation Law, accompanied by a completed approved air freight license application form prepared for this purpose.

• B- The applicant for the air transport license of chemical materials must submit a written undertaking on their official letterhead to comply with the safe transport instructions for hazardous materials by air issued by the General Authority of Civil Aviation.

6-3 The carrier of chemical materials to the Kingdom must comply with the following:

• A- Ensuring the availability of a valid prior import permit for the chemical materials issued by the competent authority in the Kingdom.

• B- The explanatory data recorded on the packages and shipments of imported or transported chemical materials and their accompanying documents must match the information contained in the import permit for these materials approved by the competent authority in the Kingdom.

6-4 The license applicant must provide proof of training and qualification of the administrative, technical specialists, and workers involved in handling and storing chemical and hazardous materials, provided that the proofs are issued by centers and institutes documented and accredited by the relevant authorities in the Kingdom.

6-5 The carrier of chemical materials by land, air, sea, or rail to the Kingdom, upon failure to comply with the requirements referred to in paragraph (6-3) above, shall return the chemical materials directly to their source by the same means of transport and shall bear the penalties and pay the financial fines resulting from this violation.

6-6 The carrier of chemical materials must not transport the materials by an unauthorized means of transport, and in the event of calling for the transport of chemical materials by another carrier, the carrier must obtain permission from the competent authority.

7-1 The Ministry of Commerce, the Ministry of Energy, and the Ministry of Industry and Mineral Resources are competent to issue licenses for the management of chemical materials or its equivalent from the competent authority, taking into account the provision contained in Article (3) of this Law, provided that it does not conflict with the text of Article Six and paragraph (3) of Article Ten of the Law, and paragraph (11/1) of the Regulation, according to its regulations and requirements for national and foreign establishments. The procedures and requirements shall be as follows:

• A- The license for managing chemical materials for commercial activity is the commercial register of the establishment, and the conditions of the commercial register or its equivalent from the competent authority apply to it.

• B- The license for managing chemical materials for industrial activity is the industrial license of the establishment, and the conditions of the industrial license apply to it.