South Africa SAHPRA’s Guidelines: for Labelling of Medicines Intended for Human Use and Adverse Drug Reactions (ADRs) Reporting

Sharan Murugan
Nov 1
2 min read

The South African Health Products Regulatory Authority (SAHPRA) plays a pivotal role in safeguarding public health by ensuring medicines are safe, effective, and properly labelled, and by maintaining robust pharmacovigilance through adverse drug reaction (ADR) reporting. In its continuous mission to strengthen medicine safety and promote patient wellbeing, the SAHPRA has issued two crucial documents:

1. Labelling of Medicines Intended for Human Use

The guideline helps pharmaceutical applicants prepare compliant label content when submitting applications for registration. It applies to:

All human medicines under Categories A (scheduled medicines) and D (complementary medicines), and
Both immediate and outer packaging of medicines.

Key Labelling Requirements

Every label submitted for registration must include:

Product name, dosage form, and strength,
Category and classification (as per Regulation 10),
Complete usage instructions,
Warnings and precautions,
Sugar content per dose, if applicable, and
Distinctive colours for different strengths to prevent medication errors.

Mock-up and Submission

Applicants must provide digital mock-ups of both the inner and outer packaging.These mock-ups:

Must be submitted in eCTD format (Electronic Common Technical Document),
Should use contrasting colours for legibility, and
Must be supplied electronically in both Word and PDF formats.

SAHPRA reserves the right to request printed specimens for review.

Why It Matters

Consistent and legible labels reduce medication errors, guide healthcare professionals, and empower patients to use medicines safely. By aligning with WHO and international labelling standards, SAHPRA reinforces South Africa’s commitment to global best practices.

For more details, please refer to the guidance: Guideline for Labelling of Medicines Intended for Human Use

2. Adverse Drug Reaction (ADR) Reporting by Healthcare Professionals

An Adverse Drug Reaction (ADR) is a noxious and unintended response to a medicine occurring at doses normally used in humans. It can result from prescription, over-the-counter, or even misuse of medicines.

Why Reporting ADRs Matters

No matter how well-tested a medicine is, some reactions only emerge once it’s widely used in the real world. Continuous reporting:

Helps identify new or rare side effects,
Improves public health protection, and
Ensures medicines remain safe and effective over time.

Pharmacovigilance System in South Africa

SAHPRA’s Pharmacovigilance Unit works alongside:

The Department of Health’s Pharmacovigilance Centre for Public Health Programmes (DoH-PvPHP), and
The Extended Programme on Immunisation (EPI).

Together, these entities track and analyse ADRs through systems like VigiFlow® and the Med Safety App—tools linked to the WHO Uppsala Monitoring Centre (UMC).