Quote from VigiServe Admin on November 28, 2020, 5:41 AMFill ADRs reporting from and send it to Saudi Food and Drug Authority through the following:
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
https://youtu.be/zsB6RlsfJI0
https://youtu.be/qwVL1T48_AU
Fill ADRs reporting from and send it to Saudi Food and Drug Authority through the following:
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
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
Quote from VigiServe Admin on July 18, 2021, 1:32 PMhttps://www.youtube.com/watch?v=LJFm78wqjTo
Quote from VigiServe Admin on September 9, 2022, 6:15 AMGuidance on Adverse Drug Events Reporting for Healthcare Professionals
Guidance on Adverse Drug Events Reporting for Healthcare Professionals
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