Advertising and Promotion of Medicines in South Africa: What the MCA Code Allows

Pharmaceutical advertising in South Africa operates within a dual regulatory framework that catches many companies off guard. The Medicines and Related Substances Act (Act 101 of 1965) sets the statutory boundaries, while the Marketing Code Authority (MCA) Code of Marketing Practice provides the self-regulatory detail. Misunderstanding either layer — or assuming one replaces the other — is the most common source of promotional compliance failures in the local market.

The Statutory Foundation: Act 101 and Its Regulations

Section 18 of Act 101 is the starting point. It prohibits the advertising of any medicine that is not registered with SAHPRA, and it restricts the advertising of Schedule 1 to Schedule 6 medicines directly to the public. Only Schedule 0 and unscheduled medicines may be advertised to consumers, and even then, the claims must align strictly with the approved indications, dosage, and conditions of use reflected in the professional information (PI) approved by SAHPRA.

Regulation 42 expands on these provisions, specifying that advertisements must not be misleading, must include the medicine's proprietary name and active ingredient, and must carry mandatory cautionary statements. For medicines advertised to healthcare professionals (HCPs), the advertisement must reference the PI and include a minimum dataset: name, scheduling status, composition, registration number, and name of the registration holder.

A critical point that companies sometimes overlook: SAHPRA does not pre-approve advertisements. The responsibility for ensuring an advertisement complies with the Act and regulations falls squarely on the registration holder. This makes internal promotional materials review processes not just good practice, but a legal necessity.

The MCA Code: Self-Regulation with Real Consequences

The MCA Code of Marketing Practice, administered by the Marketing Code Authority under the auspices of industry bodies including IPASA and SAMED, governs the ethical promotion of medicines and medical devices. While it is a self-regulatory instrument, its consequences are tangible — sanctions range from mandated withdrawal of materials and corrective advertising to significant fines and public censure.

The Code applies to all promotional activities directed at HCPs, including journal advertising, detail aids, congress materials, digital promotion, sampling, and hospitality. It requires that every promotional claim be accurate, balanced, not misleading, and substantiated by clinical evidence. Claims must not be inconsistent with the approved PI.

What Constitutes a Promotional Claim?

This is where many compliance teams struggle. A promotional claim is any representation — explicit or implied — that could influence prescribing behaviour or purchasing decisions. It extends well beyond traditional advertising to include:

• Statements made by medical representatives during detailing visits
• Slide decks and speaker presentations at sponsored symposia
• Social media posts by company accounts or sponsored influencers
• Reprints of journal articles when selected and distributed to support a particular positioning

Even a seemingly neutral statement such as "well tolerated" constitutes a claim that must be substantiated and consistent with the approved safety profile. The MCA has repeatedly ruled against companies for cherry-picking efficacy data or presenting comparative claims without head-to-head evidence.

HCP-Directed vs Consumer-Directed Promotion

The distinction matters enormously. HCP-directed promotion of prescription medicines (Schedules 1–6) is permitted under both Act 101 and the MCA Code, provided it meets the substantiation and balance requirements. Consumer-directed promotion of these same medicines is prohibited outright.

For Schedule 0 and unscheduled medicines, consumer advertising is allowed but subject to strict constraints. Claims must be confined to approved indications. Advertisements cannot reference diseases or conditions listed in Schedule 3 to the Regulations (the so-called "disease list"), and they must not create unrealistic expectations of efficacy.

Disease awareness campaigns occupy a grey zone. A campaign that educates the public about a condition without naming a specific product is generally permissible. However, when a disease awareness campaign is so closely linked to a single product — through branding elements, timing, or distribution channels — that the association becomes obvious, it risks being classified as disguised promotion. The MCA has taken an increasingly firm stance on this practice.

Common Violations and How to Avoid Them

The most frequently cited violations in MCA rulings include unsubstantiated superiority claims, use of data from unapproved indications (off-label promotion), failure to include mandatory PI references, misleading graphical representations of clinical data, and hospitality that exceeds the Code's standards of modesty.

Avoiding these pitfalls requires a structured promotional materials review process. Every piece of promotional content — whether a detail aid, a banner ad, or a conference booth panel — should pass through a medical, legal, and regulatory (MLR) review before release. Reviewers must verify each claim against the current PI and supporting references, confirm scheduling compliance, and ensure the overall impression is balanced.

Where Avidara Fits

Building a robust MLR review process depends on having immediate access to the current regulatory requirements and approved product information against which claims are checked. Avidara's Document Review service helps regulatory and compliance teams validate promotional materials against Act 101, the MCA Code, and SAHPRA guidance — reducing the risk of sanctions and protecting brand reputation. If your team needs a structured review of advertising compliance, book a review.