Every applicant is required to report ADRs known to them involving their marketed medicines in accordance with the requirements of Act 101 of 1965 Regulation 40. The success of the Authority’s ADR reporting system depends on the quality, completeness, and accuracy of the information submitted. Reporting of ADRs and monitoring thereof, remain a viable means of identifying previously unrecognized, rare, or serious ADRs.
This guideline describes the following points;
- Pharmacovigilance Obligations of The Holder Of A Certificate Of Registration/ Applicant
- Adverse Drug Reaction Reports
- Procedures for Reporting