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Health Products Vigilance Center
Reporting of Safety Information through the AE Online Reporting Program and Adverse Event Resulting from the Use of Health Product Reporting Program for Consumers
1. Reporting of safety information through the AE Online Reporting program
To report safety information through the AE Online Reporting program, an electronic channel provided by the HPVC, the user must be registered using national e-Authentication or “Open ID” in order to use the program, which can be done on the website https://accounts.egov.go.th. The user must then send a request to use the AE Online Reporting program. The right to use the program is valid for 1 year. You may request an extension the following year.
There are 2 types of users as follows. They can submit safety information reports and receive AE information service, according to the types of users.
Types of Users | Types of Safety Information Submitted or AE Information Service Received |
Marketing authorization holder/business premises registrant/specification provider | - Report of adverse event resulting from the use of health product of an individual patient (Individual Case Safety Report: ICSR) - Medical Device Defect or Adverse Event Report for a Domestic Case (Form Ror Mor Por 1) - Device Defect and Adverse Event Summary Report for Foreign Cases (Form Ror Mor Por 2) - Field Safety Corrective Action Report for Both Domestic and Foreign Cases (Form Ror Mor Por 3) - AE information service |
Healthcare professional | - Report of adverse event resulting from the use of health product of an individual patient (Individual Case Safety Report: ICSR) |
2. Adverse Event Resulting from the Use of Health Product Reporting Program for Consumers
Consumer may report any adverse event resulting from the use of health product of any category under the responsibility of the Thai Food and Drug Administration by entering the “Adverse Event Resulting from the Use of Health Product Reporting program for Consumers” on the website: https://plan.fda.moph.go.th/hpvc or fill in the Health Product Adverse Event Report Form for Consumer and send it to email: adr@fda.moph.go.th; or the Strategy and Planning Division, Thai Food and Drug Administration, Ministry of Public Health, Talat Kwan Sub-district, Muang District, Nonthaburi, 11000.