4. AE Information Services

Marketing authorization holder, business premises registrant and specification provider may request information regarding reports on adverse events resulting from the use of health products received by the HPVC and stored in the Thai Vigibase database by using the AE Online Reporting program. The information may be requested in 3 different formats: 1) by year; 2) summary; and 3) detailed report. Nonetheless, the Thai Food and Drug Administration will not disclose any information which can be used to identify the affected patients or the sources of the reports.

For more details on AE information service fees, please refer to the “Regulation of the Food and Drug Administration Re: Collection of Fees for Information Services on Adverse Reactions Resulting from the Use of Health Products, B.E. 2548 (2005)”.