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Pharmacovigilance Requirements in Saudi Arabia

Agency Website

Fill ADRs reporting from and send it to Saudi Food and Drug Authority through the following:

Online Reporting

E-mail:npc.drug@sfda.gov.sa

Call NPC at +966-1-2759222 Ext : 2317 -2356- 2353-2354- 2334-2340

Fax:+966-1-2057662

Post: National Parmacovigilance Center (NPC) Saudi Food and Drug Authority-Drug sector 3292 Northern Ring Road ALNafal district Riyadh 13312 – 2688 Kingdom of Saudi Arabia

 

What should be reported?

All Adverse reactions that might be related to the use of medicines, vaccines, herbal products and cosmetics.

Report ADRs on any of the following:

  • All suspected reactions for new drugs including minor ones

  • All serious and/or unexpected reactions for well-known drugs

  • Any increased in frequency of a given reaction.

  • All suspected ADRs associated with drug-food or drug-herb or food supplement interactions.

  • All reactions in special populations such as pregnant and breastfeeding women, children and elderly

  • When suspected ADRs are associated with drug withdrawals

  • Any other situation where you believe it needs to be reported.

AGGREGATE SAFETY REPORTING SCHEDULE

 

Guidance on Adverse Drug Events Reporting for Healthcare Professionals

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