sfda_gov_sa · regulation · processed · 4 chunks
الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Conditions and Requirements of Tobacco Products Clearance Version No.2 <table><tr><td>Issuance Date</td><td>13/01/2020</td></tr><tr><td>Date of Implementation</td><td>13/01/2020</td></tr></table> Disclaimer: The English version is a translation of the original in Arabic for information purposes only. In case of a discrepancy, the Arabic original will prevail. Saudi_FDA | www.sfda.gov.sa الامن نعتن الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Operation Sector Saudi Food and Drug Authority Please visit SFDA website for further information www.sfd.gov.sa Saudi_FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزرا Saudi Food & Drug Authority SEDA Documentation <table><tr><td>Version</td><td>Date</td><td>Author</td><td>Comments</td></tr><tr><td>1</td><td>30/01/2019</td><td>Executive Management of Compliance and Enforcement</td><td>Updated</td></tr><tr><td>2</td><td>12/1/2020</td><td>Executive Management of Compliance and Enforcement</td><td>Adding conditions and requirements for E-liquids and tobacco heated</td></tr></table> Saudi_FDA | www.sfda.gov.sa ساهه نهم الهييه العامه للغذاء والمواد Saudi Food & Drug Authority SEDA Contents: • Definitions 5 - Introduction 6 • General Conditions 7 - Import-Prohibited Tobacco Products 7 - Importation Conditions 8 - Documentations Required for Clearance 9 Saudi_FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزرا Saudi Food & Drug Authority SEDA Definitions: • The Authority: Saudi Food and Drug Authority • Sector: Operation sector in the Authority - Inspectors: Inspectors of operation sector in the Authority - Ports: Custom ports in Saudi Arabia that allows importing tobacco products through it - Clearance Permit: An approval issued by the operation sector of customs to allow entrance of products to Saudi Arabia - Importer: Establishment or authority that imports the shipment from outside Saudi Arabia. - Tobacco: A product derived from a combination of plant from Nicotiana tabacum and nicotiana rustica group and/or other combination of the two that were processed through exposure to smoke, sun, wind, fire or maturation. - Exporter: Overseas establishment or authority that exports the shipment to Saudi Arabia - Electronic Systems for Smoking: Products that work through electronic heating to smoke heated tobacco or E-liquids using the mouth to use once or multilabel times. That includes, but not restricted to: Electronic cigarettes and product of heating electronic tobacco which consists of several parts as: tube, storage, battery and electronic charger. - E-liquids: A liquid or gel compound that contains nicotine and other additives. - Heated Tobacco: Processed or non-processed tobacco that is formed as rolls, powder and granules inside capsules that uses thermal heating. Saudi FDA | www.sfda.gov.sa الامن نعتن الهييه العامه للغذاء والزرا Saudi Food & Drug Authority SEDA Introduction: Requirements and conditions of clearing tobacco products are based on technical regulations specialized for tobacco products advertised for on the GCC Standardization Origination website at www.gso.org.sa and the Authority's website at www.sfda.gov.sa which are: - Approved Technical Regulations for Tobacco Products. • Regulation of Basic Packaging of Tobacco Products. • Circulars Issued for Tobacco Products. - Anti-Smoking Law and its Regulations published on the Ministry of Health website www.moh.gov.sa. • Controls and Requirements of Electronic Systems for Smoking. Saudi_FDA | www.sfda.gov.sa ساهه نمته الهييه العامه للغذاء والزرا Saudi Food & Drug Authority SEDA General Conditions: - The importer shall be registered in the Authority through filling the approved format that is published in the Authority’s website www.sfda.gov.sa and shall submit the form with the documentations attached via the administrative calls system in the Authority’s location. - The importer shall submit a commitment to preserve the accredited records that demonstrated locations of distributing the products in the local markets after the clearance permit made by the Authority for all shipments that will be sent to Saudi Arabia. If there were any changes on the permitted products that lead to recalling the products from the markets, the importer shall bear the costs of the recalling process and advertise of such in newspapers. - Samples of tobacco shipments will be collected and will be inspected on the cost of the importer. - The tobacco product shall be processed or prepared as a final product and packed as an independent unit to display to the consumer in its final form for smoking purposes “an exception of such is raw tobacco for special usages as (pipe and hookah)” - The product label shall not include false claims. - Transportation and storage of the product shall be conducted according to the technical regulations and the approved standard specifications. Saudi FDA | www.sfda.gov.sa الاهم نتج العلويه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Import-Prohibited Tobacco to Saudi Arabia: 1. All tobacco products that are not smoked including: 2. Tobacco prepared for processing or reprocessing as, but not limited to raw tobacco. Importation Conditions: 1. Importation shipments of tobacco products to Saudi Arabia is limited to the defined ports as follows: ○ Jeddah Islamic Port. ○ King Abdelaziz Seaport in Dammam. ○ Dupa Port. ○ King Abduallah Port in Rabigh. ○ King Abdulaziz Airport in Jeddah. ○ Al Batha Port. ○ King Khaled International Airport. ○ Al Khafji Port. ○ Al Wadeeah Port. ○ Al Hadithah Port. ○ King Fahad Bridge. 2. Importing tobacco products shall be in its final form from the country of origin to Saudi Arabia directly, importation from a third part is not allowed. *An exception is made to E-liquids for smoking and heated tobacco from being imported from the country of origin directly and can be imported through a third party. Saudi FDA | www.sfda.gov.sa الامم نعتي الهييه العامه للغذاء والزرا Saudi Food & Drug Authority SEDA Documentations Required for Clearance: 1. A copy of the manufacturing company invoice accredited from the Chamber of Commerce in the country of origin. The invoice shall include the following: ○ Number and date of invoice. ○ Type name. - Batch number and production date of the product. - Quantity, base unit and the package size. ○ Manufacturing company’s name, nationality and address. 2. A copy of the shipment policy. 3. A copy of the customs declaration. Saudi_FDA | www.sfda.gov.sa ساهه نهم