What SAHPRA Looks for in a Pharmaceutical Artwork Review
Artwork rejections are one of the most common causes of submission delays in South Africa. Here is what SAHPRA checks and how to get it right the first time.
Pharmaceutical artwork — the printed material on packaging, labels, and package inserts — is one of the most heavily scrutinised elements of a SAHPRA submission. A single typographical error, a missing mandatory statement, or a claim that does not appear in the approved PI can delay registration by months. Yet artwork rejections remain one of the most common causes of back-and-forth between applicants and the regulator.
Understanding exactly what SAHPRA checks is the first step to getting it right the first time.
The regulatory basis for artwork review
SAHPRA's artwork review is governed primarily by the Medicines and Related Substances Act 101 of 1965, the General Regulations published under that Act, and the MCA Code of Practice for the Advertising of Medicines (Version 18). For prescription medicines, the package insert (PI) is the anchor document — every claim, indication, and safety statement on packaging or promotional material must be traceable to the approved PI.
What SAHPRA checks: the key elements
1. Mandatory label statements
South African pharmaceutical labels must carry a specific set of mandatory elements. These include the proprietary name, the International Non-proprietary Name (INN) or approved name, strength, dosage form, route of administration, pack size, batch number, manufacturing date, expiry date, storage conditions, and the name and address of the responsible person. Missing or incorrectly formatted elements are automatic deficiencies.
2. Scheduling statement
Every scheduled medicine must carry the correct scheduling statement, displayed in a scheduling box as required by the Regulations. The wording must match the approved scheduling — neither abbreviated nor paraphrased. This is a frequent source of errors, particularly when companies copy formatting across products and the schedule has changed.
3. Consistency with the approved PI
Every indication, contraindication, warning, and claim on the label or carton must appear in the approved PI verbatim or in a form that does not add to, or deviate from, the approved text. If the PI says "adults and children over 12 years" and the label says "adults and adolescents", that is a deficiency — even though the intent is the same.
4. Storage and disposal conditions
Storage conditions must be stated in precise temperature ranges, not vague descriptors. "Store in a cool, dry place" is not acceptable — "Store below 25°C" is. Disposal instructions for the patient and for unused medicine must also be present on patient-facing materials. These are small details that reviewers check consistently.
5. Barcodes and pack codes
SAHPRA requires that the registration number, which includes the scheduling schedule and the product code, appears in a format that can be machine-read. The barcode must be present and readable. This is an element that design teams often overlook when preparing artwork for a new market.
6. Promotional material and the MCA Code
For HCP-directed promotional materials, the MCA Code of Practice applies. Promotional claims must be substantiated by the approved PI, must not be misleading, and must include the mandatory prescribing information (MPI) panel formatted to Code requirements. The reference list must include only peer-reviewed sources that directly support the claims made.
The most common reasons for artwork rejection
- Scheduling box incorrectly formatted or missing
- Claims on the carton that are not in the approved PI
- Storage conditions stated as descriptors rather than temperature ranges
- INN not displayed with equal or greater prominence than the proprietary name
- Wrong registration number format
- Promotional material reviewed against an outdated PI version
- Mandatory statements absent from one side of a double-sided label
How to reduce the risk of rejection
The most effective approach is a structured pre-submission review against a checklist derived from the current regulations and the approved PI — not a general sense-check. Every element on the label should be traced to either a mandatory regulatory requirement or an approved PI statement. Discrepancies should be resolved before artwork is finalised, not discovered during SAHPRA review.
Independent review — by someone who had no part in drafting the artwork — is the most reliable way to catch the errors that internal teams miss. Familiarity with a document makes it harder, not easier, to spot deviations.
Where Avidara fits in
Avidara's Document Review is designed for exactly this use case. Upload your artwork or label, specify the relevant product and schedule, and Avidara checks it systematically against the mandatory requirements and the approved PI. The output is a structured gap report — Critical, Major, and Minor findings — formatted for your MLR file with same-day turnaround for standard artwork reviews.
If you are preparing artwork for a SAHPRA submission or approaching a batch release deadline, book a Document Review.
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