RegulinkedSFDA has issued a new regulatory guide clarifying the services and requirements applicable to food and pharmaceutical products handled within Special Economic Zones, the Integrated Logistics Special Zone, Bonded Zones, and other duty and tax suspended areas in Saudi Arabia.
🔍 What’s New
The guide provides a structured regulatory framework for companies storing, processing, manufacturing, exporting, re-exporting, or clearing food and pharmaceutical products through these zones.
The services include:
The services include:
1. Export Services (Optional)
These services are optional for companies exporting or re-exporting products outside Saudi Arabia:
- Issuance of a Food Export Certificate
- Issuance of a Pharmaceutical Export Certificate
Requirement:
Companies must meet the applicable documentation & requirements specified for each export service.
2. Clearance Services (Mandatory)
These services are mandatory when products are intended to enter the Saudi local market:
- Clearance of Food Products
- Clearance of Pharmaceutical Products and Raw Materials Used in Their Manufacturing
Requirement:
Clearance applications must be submitted through the Faseh Portal and must comply with all applicable SFDA clearance conditions and requirements for the relevant product category.
Additional Note:
GDP or GMP certification is required depending on the storage, manufacturing, processing, or handling activities performed within the zone.
3. Technical Certification Services for Establishments
These services cover:
- Issuance of a Good Storage and Distribution Practice Certificate (GDP)
- Issuance of a Good Manufacturing Practice Certificate (GMP)
Requirement:
Establishments must comply with the applicable GDP or GMP requirements, complete any required inspection, and provide evidence of payment of the applicable fees.
💡 Why it Matters
The guide distinguishes between optional services for international export and mandatory requirements for products entering the Saudi local market, while also clarifying the role of GDP and GMP certification.
📌 How ReguLinked Can Support
ReguLinked can support companies with:
- Free-zone regulatory pathway assessments
- Food and pharmaceutical clearance readiness
- Export and re-export documentation support
- GDP and GMP compliance preparation
- Product registration and marketing authorisation support
- Quality-system and operational compliance reviews
Planning to establish, store, process, export, re-export, or clear regulated products through a Saudi free-zone environment?
Let ReguLinked support your regulatory readiness with a fully SFDA-aligned free-zone and market-entry strategy.
“Book your complimentary consultation today”
📧 bd@regulinked.com | 🌐 www.regulinked.com
📎 Official guideline— Arabic Only:
1- Regulatory Guide for SFDA Services in Duty- and Tax-Suspended Zones
#ReguLinked #SFDA #SaudiArabia #SpecialEconomicZones #FreeZones #Pharmaceuticals #FoodRegulations #RegulatoryCompliance
