South Africa Pharma Regulatory Compliance: Full Overview

South Africa’s move toward pharmaceutical traceability is no longer theoretical. With the publication of the South African Health Products Regulatory Authority (SAHPRA) traceability guidelines and implementation roadmap, manufacturers now have clear regulatory direction, phased timelines, and explicit expectations around data, systems, and readiness.

However, as with most traceability regulations globally, the challenge is not what is written in the guidelines. It is how manufacturers interpret it and translate it into practical action.

This article distils SAHPRA’s requirements and, more importantly, explains what they mean in practice for manufacturers planning their traceability journey over the next several years.

‍

1. Why SAHPRA Is Implementing Traceability

SAHPRA’s traceability initiative is designed to strengthen patient safety and supply chain integrity by enabling visibility of health products as they move through the market.

At a high level, SAHPRA aims to:

• Enable track-and-trace of regulated health products
• Reduce the risk of falsified and diverted medicines
• Align South Africa with global GS1-based traceability standards
• Transition the industry from batch-level identification to unit-level traceability

Traceability is not being introduced as a one-time compliance exercise, but as a progressive capability that matures over time.

‍

2. Scope and Exemptions: Who Is Affected?

The SAHPRA traceability guideline applies broadly to health products regulated by the Authority, unless a product is explicitly exempted.

For manufacturers, this makes scope determination a critical first step. Traceability obligations are not optional by default, and assumptions around exclusion often lead to downstream compliance gaps.

Products Explicitly Exempted from Traceability

SAHPRA has clearly identified certain product categories that are out of scope for traceability requirements. These include:

• Whole blood and blood components
• Homeopathic medicines and allied substances
• Extemporaneous preparations
• Medicines imported for personal use only (authorised)
• Unregistered medicines imported under authorisation
• Donated medicines imported for emergency cases (authorised)
• Food and related supplements
• Investigational drugs
• Products manufactured and labelled before their applicable unique identification compliance dates
• Any other product category that SAHPRA may determine

These exemptions are explicit and intentional, reflecting different regulatory controls or risk profiles.

What This Means in Practice

While the exemption list provides clarity, SAHPRA places responsibility on manufacturers to:

• Confirm exemption status on a product-by-product basis
• Maintain formal documentation supporting exemption claims
• Avoid assuming exemption across an entire portfolio without validation

One of the most common early traceability missteps is incorrect scope classification. Errors at this stage often cascade into avoidable rework in packaging, data, and systems later in the programme.

‍

3. Implementation Timelines: Overview

Rather than imposing a single “go-live” date, SAHPRA has defined a multi-year, phased rollout, differentiated by:

• Imported vs locally manufactured products
• Batch-level vs unit-level identification

‍

Early phases are not optional placeholders. Decisions made during batch-level implementation (data models, systems, packaging design) directly impact the cost and feasibility of later unit-level serialisation.

‍

4. Implementation Timelines: Detailed

a. Primary Packaging - blisters, bottles, direct product contact

b. Secondary Packaging - retail cartons containing one or more primary packs

c. Tertiary Packaging (Trade Items) - cases, cartons sold as trade items

d. Tertiary Packaging (Logistics Units) - pallets and shipping units

‍

4. Identification Requirements: Overview

Data Elements Requirements

SAHPRA specifies a clear set of core identification data elements, aligned to GS1 standards, including:

‍

Brand owner/Manufacturer shall notify the Authority of any other information it intends to add to the data carrier.

‍

Technical & Quality Standards Requirements

• Compliance with GS1 General Specifications
• Barcode print quality of Grade C (1.5) or higher
• Alignment with:
  
  • ISO/IEC15416:2016 (Linear barcodes)
  • ISO/IEC15415:2011 (2D barcodes)

‍

5. Identification Requirements: Packaging-Level Breakdown

‍

6. Electronic Record-keeping Requirements

One of the most important, and frequently overlooked, statements in the guideline is SAHPRA’s requirement that:

“The relationship between the unique identifiers of different packaging levels shall be captured in the manufacturer’s electronic internal systems.”

In practice, this means manufacturers must:

• Capture parent–child relationships (unit → carton → case → pallet)
• Store these relationships electronically
• Retain them for five years post-expiry
• Retrieve them upon regulatory request

SAHPRA does not store this data on behalf of manufacturers, nor does it prescribe system architecture.

Printing serial numbers without electronic aggregation data is insufficient. Aggregation is not a “future nice-to-have”. It is embedded in the regulatory expectation.

‍

7. Master Data: The Hidden Foundation of Traceability

SAHPRA requires manufacturers to manage and submit accurate product and location master data, but it does not create or manage this data itself.

Manufacturers are responsible for:

• Assigning GTINs for all packaging levels
• Assigning GLNs for manufacturing, warehousing, and distribution locations
• Maintaining accurate GTIN–GLN mappings
• Ensuring consistency across regulatory submissions and internal systems
  ‍

Master data errors propagate quickly and are extremely difficult to correct once serialisation and aggregation are live.

‍

8. What SAHPRA Has Not Defined

The guideline clearly states that certain areas are out of scope, including:

• Downstream data capture at healthcare establishments
• Prescribed master data system architectures
• Interoperability standards across all supply-chain levels

However, SAHPRA’s roadmap confirms that:

• Data sharing expectations will evolve
• Portal enhancements are planned
• Trading partner alignment is required

‍

9. Manufacturer Readiness: What Should Be Done in the Next 12 Months?

• Governance: Traceability must be owned across Quality, Supply Chain, Packaging and IT, and not treated as a packaging or IT-only project.
• Data Foundations: Product, packaging, and location master data must be accurate, governed, and future-ready.
• Aggregation Capability: Systems must support electronic capture of packaging hierarchies from the outset.
• Audit Readiness: Assume traceability data may be requested at any time; avoid manual reconstruction.
• Scalable Systems: Accommodate future data exchange and reporting requirements without redesign.

‍

10. The Bigger Picture

SAHPRA’s traceability framework is mandatory and phased. Each phase builds on the previous one, and early decisions are difficult to undo.

Manufacturers that treat traceability as a strategic capability, rather than a compliance milestone, are better positioned to:

• Meet future regulatory expectations
• Reduce operational disruption
• Scale across markets with similar traceability trajectories

‍

Conclusion

SAHPRA has provided clarity on what is required. The responsibility now lies with manufacturers to decide how thoughtfully they plan and respond. Traceability is not just about meeting deadlines. It is about building systems and data foundations that can evolve as regulation matures.

‍

References

• Guideline on Traceability of Health Products (Oct 2025)
• Traceability Guideline – Implementation Roadmap (Sept 2025)

Frequently Asked Questions (FAQs)

1. Does SAHPRA traceability apply to all products?

No. SAHPRA traceability applies to health products regulated by the Authority, unless a product is explicitly exempted. SAHPRA has published a clear list of exempted product categories. Manufacturers are responsible for confirming and documenting exemption status for each product.

2. If my product is exempted, do I need to do anything further?

Yes. Even for exempted products, manufacturers should:

• Formally confirm the exemption status
• Maintain internal documentation supporting the exemption
• Reassess applicability if the product, supply channel, or regulatory status changes

Exemption should never be assumed without documentation.

3. Is SAHPRA only asking for barcodes on packs?

No. While barcodes are required, SAHPRA’s expectations go beyond labelling. Manufacturers must also manage traceability data electronically, including relationships between different packaging levels and the ability to retrieve this data upon request.

4. Is unit-level serialisation required from Day 1?

No. SAHPRA has defined a phased rollout, starting with batch-level identification and progressing to unit-level serialisation over several years. However, early implementation decisions should account for future unit-level requirements to avoid rework later.

5. Does SAHPRA operate a central traceability or serial number repository?

No. SAHPRA does not operate a national repository for serial numbers or aggregation data. Manufacturers are expected to store traceability data within their own systems and make it available to SAHPRA upon regulatory request.'

6. Is aggregation really mandatory, or only a future expectation?

Aggregation is an explicit regulatory expectation, and not an optional future step. SAHPRA requires manufacturers to electronically capture and retain the relationships between unique identifiers at different packaging levels (e.g. unit, carton, case, pallet).

7. When should manufacturers start preparing for SAHPRA traceability?

Preparation should begin well before the applicable compliance dates. Governance, master data, packaging design, and system choices made early have long-term implications. Manufacturers that prepare only for initial phases often face higher costs and operational disruption later.