RegulinkedSFDA has published six guidelines regarding classification of violations and associated penalties across key regulated sectors in Saudi Arabia.
The guides cover feed, cosmetics, food, veterinary products, pharmaceutical and herbal products, and medical devices, with compliance expectations spanning the full regulated product lifecycle.
🔍 What’s New
The guides demonstrate that regulatory exposure may arise across the full product lifecycle, from establishment licensing and product registration to manufacturing, quality control, distribution, advertising, post-market surveillance, recall, and withdrawal activities.
Key compliance areas include:
- Conducting regulated activities without the required SFDA license
- Failure to meet pharmacovigilance or adverse-event monitoring obligations
- Failure to appoint the required technical manager or qualified responsible person for local manufacturing
- Marketing or distributing products that are not registered, listed, or authorized
- Failure to implement applicable quality management requirements
- Non-compliant storage, transportation, traceability, recall, or withdrawal practices
Penalty Assessment Note:
The applicable financial penalties are determined based on factors including the size of the establishment (large, medium, small) and the regional category where the violation occurs. The guides may also calculate penalties per establishment, product, case, shipment, transport operation, or other specified unit, depending on the nature of the violation.
💡 Why it Matters
Companies should review the guide relevant to their regulated activities and assess whether their current licensing, product, quality, safety, and operational controls adequately address the listed violations.
Compliance responsibilities should also be clearly assigned across Regulatory Affairs, Quality, Pharmacovigilance, Supply Chain, Manufacturing, Marketing, and Legal functions.
📌 How ReguLinked Can Support
ReguLinked can support companies with:
- SFDA compliance gap assessments
- Establishment licensing and regulatory readiness
- Product registration, listing, and marketing authorisation support
- Quality system and operational compliance reviews
Planning to assess how the new SFDA violation guides may affect your products, establishments, or regulatory operations?
Let ReguLinked support your regulatory readiness
“Book your complimentary consultation today”
📧 bd@regulinked.com | 🌐 www.regulinked.com
📎 Official guideline— Arabic Only:
1- Pharmaceutical and Herbal Products Violations and Penalties Guide
2- Medical Devices Violations and Penalties Guide
3- Veterinary Products Violations and Penalties Guide
4- Feed Violations and Penalties Guide
5- Food Violations and Penalties Guide
6- Cosmetic Products Violations and Penalties Guide
#ReguLinked #SFDA #SaudiArabia #RegulatoryCompliance #MedicalDevices #Pharmaceuticals #MarketAccess #RegulatoryAffairs
