GUIDELINES NOTICE BOARD

Document NumberGuideline NameDate UploadedVersionUnitDownload
2.33Post-marketing reporting of adverse drug reactions to human medicines in South AfricaOctober 27, 20219PHARMACOVIGILANCE
5.08Reliance GuidelineOctober 13, 20212GENERAL, ECTD & HUMAN MEDICINES GUIDELINES
2.11Safety Reporting During Clinical TrialsOctober 12, 20214CLINICAL TRIALS
9.129Re-submission of BAU New Medicines Applications from 2018 and 2019October 5, 20211ORTHODOX MEDICINES
2.66Guideline for Lot release of human vaccinesOctober 4, 20211ORTHODOX MEDICINES
5.09GUIDELINE ON HOW TO LODGE A COMPLAINT ON MEDICINES AND MEDICAL DEVICESOctober 4, 20212REGULATORY COMPLIANCE
8.05CLASSIFICATION of MEDICAL DEVICES and IVDsSeptember 10, 20215MEDICAL DEVICES
2.64Availability of medicines for use in a public health emergencyAugust 25, 20211GENERAL, ECTD & HUMAN MEDICINES GUIDELINES
2.52Section 21 Access to Unregistered MedicinesAugust 25, 20213UNREGISTERED PRODUCTS
2.04Post importation testing guidelineAugust 23, 20214INSPECTORATE & REGULATORY COMPLIANCE