Drugs

Product Recall Guidance

2023-09-21
Product Recall Guidance
Guide
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Question

What are the custom entry ports designated to drug products?


Answer

1.   King Khaled airport – Riyadh 2.   King Abdulaziz airport - Jeddah 3.   King Fahad Airport – Dammam  4.   Prince Mohammed Bin Abdulaziz International Airport – Medina 5.   King Abdulaziz sea port - Dammam 6.   King Abdullah Sea port - Rabigh 7.   Jeddah Islamic sea port 8.   Dry port – Riyadh 9.   Al-Batha outlet - Al-Ahsaa 10.   King Fahd Causeway- Al Khobar 11.   Al- Khafji outlet 12.   Al-Hadethah outlet – Qurayyat 13.   Salwa outlet


Question

What are the drug clearance conditions and requirements?


Answer

Drug clearance conditions and requirements are published at:  (Click here)  


Child resistant packaging requirements

2023-08-06
Child resistant packaging requirements
Guide
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Clinical Considerations for Efficacy and Safety Assessment

2023-07-09
Clinical Considerations for Efficacy and Safety Assessment
Guide
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The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products Guideline

2023-06-04
The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products Guideline
Procedural rule
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Application for Import of personal products

2023-06-04
Application for Import of personal products
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Application for Export of personal products

2023-06-04
Application for Export of personal products
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Guidance for Orphan Drug Designation

2023-06-04
Guidance for Orphan Drug Designation
Guide
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Guideline on the Braille Requirements for Labeling Information of Medicinal Products for Human Use

2023-06-01
Guideline on the Braille Requirements for Labeling Information of Medicinal Products for Human Use
Guide
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