The South African Health Products Regulatory Authority (SAHPRA) recently updated its Guideline for proprietary names for medicines, which governs the evaluation and registration of medicine names in South Africa. SAHPRA, responsible for regulating medicines and health products to ensure their safety, efficacy, and quality, has a dedicated Names and Scheduling Unit that assesses the suitability of proposed proprietary names.
The revised guideline provides detailed direction to applicants, certificate holders, and regulatory pharmacists on how SAHPRA evaluates medicine names. Proprietary names refer to the unique, registered names of individual medicines and their line extensions. SAHPRA mandates that all approved proprietary names must be unique, distinctive, and readily recognizable to prevent look-alike and sound-alike confusion among healthcare providers and patients.
The guideline distinguishes between different types of names: Product Names, Umbrella Names, and Company Identifiers or House Brands. Umbrella Names, which cover a range of co-branded but differentiated products targeting specific conditions, are viewed with caution by SAHPRA due to potential consumer confusion. Company Identifiers allow manufacturers to associate their company name with products, aiding brand recognition.
SAHPRA’s assessment of proposed names focuses on public health and safety concerns. Names are tested to ensure they do not mislead, pose risks, or cause confusion. The guideline encourages proprietary names to be single invented words, as longer or multiple-word names increase the risk of confusion and abbreviation. Certain characters such as hyphens and symbols (+, &, #, @, =, [, ], ') are prohibited, and terms implying absolute efficacy (e.g., "MAX", "CURE", "STOP") are discouraged. Common English words and popular personal names are generally not accepted. However, qualifiers or abbreviations that provide additional product information, like strength or dosage form, are permissible.
Importantly, SAHPRA’s approval of a proprietary name grants a form of exclusivity distinct from trade mark registration under South Africa’s Trade Marks Act (No. 194 of 1993). While trade mark registration protects intellectual property and commercial interests, SAHPRA’s name approval prioritizes patient safety and public health. These two systems operate independently.
Crucially, SAHPRA does not consider existing trade mark registrations when evaluating proprietary names. Pharmaceutical companies cannot rely on trade mark registration alone to secure SAHPRA approval. Instead, SAHPRA applies its own safety and clarity criteria, assessing potential confusion in print, handwriting, or speech. Factors considered include registered indications, patient populations, dosage forms, routes of administration, strengths, dispensing settings, scheduling status, and risks of prescribing or dispensing errors.
Moreover, proprietary names must not mislead regarding therapeutic effects, composition, or safety. SAHPRA aligns with World Health Organization guidelines protecting International Non-Proprietary Names (INN) through the use of INN stems.
The guideline explicitly states that SAHPRA does not address intellectual property infringement concerns. It disclaims any role in determining whether a proprietary name infringes on another’s IP rights, noting that such issues are outside SAHPRA’s mandate and are not considered during name approval.
Similarly, SAHPRA’s approval cannot be used to assert intellectual property rights or trade mark ownership. Approval does not establish or confirm trade mark validity.
Given these distinctions, pharmaceutical companies must adopt a strategic, dual-track approach to medicine naming. This involves balancing “safety-distinctive” names that meet SAHPRA’s regulatory standards with “marketing-distinctive” names that are strong trade mark candidates. A name highly distinctive as a trade mark may still be rejected by SAHPRA for safety or misleading concerns, while a SAHPRA-approved name may face trade mark availability or infringement risks.
The guideline notes that SAHPRA may consider approvals from other major regulatory authorities but emphasizes that foreign acceptance does not guarantee approval in South Africa. Therefore, companies are advised to develop multiple ranked name options and submit at least three proposed proprietary names per application. Concurrent trade mark clearance searches on these options are recommended.
This creates a “timing trap” where regulatory naming review and trade mark clearance must be integrated into a single project plan with shared decision points, rather than handled sequentially by separate teams.
The practical impact of SAHPRA’s updated guideline on the proprietary name approval process in South Africa remains to be seen. However, it clearly underscores the need for coordinated regulatory and intellectual property strategies in pharmaceutical branding.
This article provides a general overview and does not substitute for specialist advice tailored to specific circumstances.