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Table of Contents Introduction About Funky Socks Day (and why it matters) Who Benefits From Funky Socks Day? Outcome (and why participation today matters) What this means for MC Pharma’s community involvement How you can get involved (right now) Funky Socks Day Images Frequently Asked Questions (FAQ) Contact MC Pharma for Your Pharmaceutical Regulatory Needs Introduction Today, 12 September 2025, South Africans and Namibians are wearing their funkiest socks in support of vulnerable children. Funky Socks Day , led by PNA, raises funds through R10/N$10 sticker sales, with proceeds benefiting Breadline Africa, CHOC Childhood Cancer Foundation, Rally to Read, and Matla a Bana. These organisations focus on early childhood development, literacy, and care for children in crisis . For schools, companies, and communities, the initiative is a fun, accessible way to contribute to meaningful causes — and a reminder that small acts of solidarity can make a big impact. About Funky Socks Day (and why it matters) Funky Socks Day is celebrated annually on 12 September. Participants wear bright, mismatched, or patterned socks while contributing R10 for a sticker. The campaign combines fun with purpose — showing children that communities care, while raising funds for vital development and protection programmes. By joining in, schools, businesses, and individuals help raise millions of rand each year for charities that create safer learning spaces, fight illiteracy, and support children facing illness or abuse. Who Benefits From Funky Socks Day? Breadline Africa  – builds and refurbishes safe early childhood development centres, replacing unsafe structures with proper classrooms, kitchens, and toilets. CHOC Childhood Cancer Foundation SA   – supports children with cancer and blood disorders, ensuring continuity of education and emotional care during treatment. Rally to Read  – delivers books, trains teachers, and empowers parents to strengthen literacy in under-resourced schools. Matla a Bana   – provides comfort packs and support for children who have suffered abuse, working alongside police and hospitals. Outcome (and why participation today matters) Funds raised  directly impact early learning, literacy, and child safety programmes. Awareness created  by wearing funky socks reminds everyone that vulnerable children need ongoing support. Community unity : schools, offices, and households across South Africa and Namibia join hands in a shared cause. What this means for MC Pharma’s community involvement As a trusted   licensed regulatory-pharmaceutical consultancy , MC Pharma recognises that health, safety, and education are interlinked . Supporting initiatives like Funky Socks Day aligns with our values of respect, equality, and responsibility to society. Today, our team proudly wears funky socks to: Raise awareness about literacy and ECD. Encourage clients, colleagues, and friends to participate. Showcase our commitment to community-based initiatives beyond the regulatory environment. Our broader mission is to uphold integrity and patient safety — from   pharmacovigilance and ADR reporting support  to   distribution & wholesale under SAHPRA   and   end-to-end eCTD management . Taking part in Funky Socks Day is a natural extension of our role in promoting well-being across society. How you can get involved (right now) Buy your sticker  at PNA (R10 in South Africa / N$10 in Namibia). Wear your funky socks  today and show your support. Post on social media  using #FunkySocksDay2025 and #RockYourFunkySocks. Donate or volunteer  directly through the beneficiary organisations. 👉 Learn more and get involved via PNA Funky Socks Day 👉 Contact MC Pharma   if you’d like to partner with us on future community initiatives. Funky Socks Day Images Frequently Asked Questions (FAQ) What is Funky Socks Day?   It’s a fundraising initiative held annually on 12 September in South Africa and Namibia to support vulnerable children, literacy, and early childhood development. How much does it cost to participate?   Participation is R10 in South Africa or N$10 in Namibia for a sticker, plus wearing your funkiest socks. Where does the money go? Funds are donated to Breadline Africa, CHOC Childhood Cancer Foundation, Rally to Read, and Matla a Bana. Can schools and companies take part? Yes — schools and businesses across both countries actively participate by selling stickers, wearing socks, and raising awareness. What if I don’t have funky socks? You can still support by buying a sticker, making a donation, or spreading awareness online. Contact MC Pharma for Your Pharmaceutical Regulatory Needs Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Introduction In the highly regulated pharmaceutical industry, ensuring safety, efficacy, and quality of medicines is paramount.  This process does not end at product registration but continues throughout the entire lifecycle of a medicine.  The ongoing vigilance is known as Pharmacovigilance. For companies entering or operating in the South African pharmaceutical market, pharmacovigilance is not just a regulatory obligation — it is an ethical responsibility. At MC Pharma, we serve as your trusted partner in navigating these critical safety requirements, offering end-to-end pharmacovigilance solutions aligned with the latest SAHPRA  (South African Health Products Regulatory Authority) regulations. What is Pharmacovigilance? Pharmacovigilance refers to the scientific and systematic process of detecting, assessing, understanding, and preventing adverse drug reactions (ADRs) or other drug-related issues . Globally recognised by the World Health Organization (WHO) , pharmacovigilance aims to ensure that medicinal products remain safe and effective when used by patients under real-world conditions. In South Africa, pharmacovigilance is governed by SAHPRA , which mandates that all licensed pharmaceutical companies and marketing authorisation holders (MAHs/Applicants) implement pharmacovigilance systems as per local regulatory requirements. Source: SAHPRA Pharmacovigilance Guidelines Why is Pharmacovigilance Important? Protects Patient Safety:  Early detection and management of adverse drug reactions reduce the risk of serious health consequences. Regulatory Compliance:  Compliance with SAHPRA is mandatory for maintaining market authorisation. Public Confidence:  Builds trust with healthcare professionals, patients, and regulators. Risk-Benefit Monitoring:  Continuous monitoring, trending and reporting ensures that the benefit-risk profile of a product remains positive throughout its lifecycle. Pharmacovigilance Requirements in South Africa (SAHPRA Standards) South Africa’s regulatory framework is aligned with ICH E2E  global standards and WHO guidelines, while incorporating country-specific nuances: ADR Reporting Timelines Serious ADRs: report within 15 calendar days . Non-serious ADRs: report within 90 calendar days . Risk Management Plans (RMPs) Mandatory for all new marketing authorisation applications. Must be updated periodically and submitted to SAHPRA. Pharmacovigilance Officer (QPPV Equivalent) Companies must appoint a trained, dedicated pharmacovigilance officer responsible for all safety-related submissions and communications with SAHPRA. Continuous Safety Monitoring Regular collection, assessment, and reporting of adverse events. Compliance Inspections SAHPRA regularly conducts inspections to ensure MAHs comply with pharmacovigilance requirements. The Pharmacovigilance Process: Step-by-Step Signal Detection Identification of new or known adverse drug reactions through spontaneous reports, literature, and post-marketing studies. Adverse Event Collection Collection and documentation of ADRs via healthcare professionals, patients, or internally. Assessment & Analysis Evaluation of the seriousness, expectedness, and causal relationship. Regulatory Reporting Submission to SAHPRA in line with required timelines via the official ADR Reporting Portal or email: adr@sahpra.org.za Risk Management Implementation of RMPs, including minimisation measures and ongoing monitoring. Training & Awareness Ensuring all internal and external stakeholders are trained on pharmacovigilance obligations. MC Pharma's Pharmacovigilance Services At MC Pharma , we offer an integrated pharmacovigilance solution that covers the entire regulatory and safety spectrum for companies entering or operating in the Southern African region. Our Services Include: Acting as your official local Marketing Authorisation Holder (MAH) and QPPV . Establishing and maintaining SAHPRA-compliant pharmacovigilance systems . Risk Management Plan  development, implementation, and maintenance. Management of local ADR collection , assessment, and reporting. Monitoring of regulatory safety  data  Internal audits  and regulatory compliance inspections . Pharmacovigilance training for your teams . SAHPRA liaison  for all safety-related matters. Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma is your strategic partner for patient safety , regulatory excellence , and market success . Best Practices for Implementing Pharmacovigilance If you are an international or local pharmaceutical company planning to enter the Southern African market, these are essential steps: Establish a local pharmacovigilance system that meets SAHPRA requirements. Appoint a dedicated qualified pharmacovigilance officer or outsource to MC Pharma’s QPPV. Develop and maintain a robust Risk Management Plan (RMP). Implement internal SOPs governing ADR collection and reporting. Regularly update safety data and submit Periodic Safety Update Reports (PSURs). Train internal teams on pharmacovigilance obligations. Recommended Resources: SAHPRA Official Website WHO Pharmacovigilance ICH E2E Pharmacovigilance Guideline MC Pharma Services Overview Frequently Asked Questions (FAQ) What is Pharmacovigilance?   Pharmacovigilance is the practice of monitoring, detecting, and preventing adverse drug reactions (ADRs) to ensure medicines are safe and effective during real-world use. Who regulates Pharmacovigilance in South Africa?   The South African Health Products Regulatory Authority (SAHPRA)  governs all pharmacovigilance activities in the country. What counts as an ADR?   An Adverse Drug Reaction (ADR)  is any unwanted or harmful reaction resulting from the use of a medicinal product under normal conditions. What happens if ADRs are not reported?   Failure to report ADRs within the SAHPRA-specified timeframes may result in regulatory sanctions, suspension of marketing authorisation, or product recalls. How does MC Pharma assist with Pharmacovigilance?   MC Pharma offers full pharmacovigilance services including ADR reporting, Risk Management Plan development, pharmacovigilance system setup, and acting as your official MAH. Contact MC Pharma for Your Pharmacovigilance Needs 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

What is SAPHEX? The South African Pharmaceutical Exhibition (SAPHEX)  is Africa’s premier forum for pharmaceutical manufacturing, packaging, supply-chain and regulatory stakeholders. Scale & purpose —  The 2025 edition hosted 100+ exhibitors  and 2 000+  professionals at Johannesburg’s Sandton Convention Centre , delivering two days of expert talks, live demonstrations and networking under the banner “Uniting Healthcare.” Knowledge streams —  Delegates moved between a GMP/GDP symposium and hands-on Strategnos workshops that covered SAHPRA inspections, pharmacovigilance, validation and logistics. Co-located power —  SAPHEX shares the floor with   The Pharmacy Show (TPS ), GP Expo  and The Hospital Show , giving visitors a one-stop venue where pharmacists, GPs and hospital leaders explore end-to-end healthcare innovation. MC Pharma – 26 Years of Regulatory Depth and Market Reach Founded in 1999, MC Pharma (Pty) Ltd. holds licences under Section 22C of the Medicines & Related Substances Act 101 of 1965 and serves as Marketing Authorisation Holder (MAH) and SAHPRA liaison for local and global clients. Comprehensive, Modular Services Regulatory intelligence & eCTD publishing  – 1 500+ dossiers compiled and maintained. Quality assurance (QA/QMS)  – GMP-aligned systems, GLP/SANAS support and audit readiness. Sales & marketing  – national key-account coverage across South Africa, Namibia, Lesotho, Botswana and Eswatini. Import & export logistics  – customs clearance, bonded storage and cold-chain management through various distributors and wholesalers Global Perspective, Local Precision MC Pharma supports innovators from the UK, Australia, Brazil, China, India, Israel, Germany, France and the USA while contributing expertise to industry bodies such as MCA, SMASA and SAPRAA. The company’s mission upholds integrity, transparency and empowerment, safeguarding patient health by delivering compliant products to African markets. Mnandi Pharma – Medical-Device Partner & Sister Company Mnandi Pharma , a strategic partner to MC Pharma, focuses exclusively on medical devices and in-vitro diagnostics (Classes A–D). Core Competencies SAHPRA establishment licensing  – guiding manufacturers through applicant, importer and distributor approvals. Import / export administration  – bonded storage, customs clearance and temperature-controlled consignments. Distribution oversight  – managing national wholesaler networks for rapid, compliant rollout. Product classification advice  – helping clients determine the correct risk class and document route. Synergy With MC Pharma By combining Mnandi’s device expertise with MC Pharma’s medicines portfolio, clients enjoy a single integrated partner for multi-category product launches—a strength showcased at their joint Silver Sponsor  stand during SAPHEX 2025. Why SAPHEX Matters South Africa’s pharmaceutical market is forecast to exceed US $6 billion by 2026. SAPHEX delivers direct insight from SAHPRA, unveils first-to-market technologies and fosters partnerships essential for success in a rapidly expanding African sector. Register Now for SAPHEX 2026 SAPHEX returns 25 – 26 March 2026  at Sandton Convention Centre, with 25% more floor space already reserved. Secure your delegate or exhibitor pass today   and stay ahead in Africa’s evolving pharmaceutical landscape. Download Event Prospectus SAPHEX Event Images Frequently Asked Questions (FAQ) What does SAPHEX stand for?   South African Pharmaceutical Exhibition—Africa’s flagship platform for pharma manufacturing, packaging and regulation. How long has MC Pharma operated?   26 years (est. 1999). How is Mnandi Pharma related to MC Pharma? Mnandi Pharma is MC Pharma’s sister company and strategic partner focusing on medical-device licensing, import/export and distribution. When and where is SAPHEX 2026? 25 – 26 March 2026 at Sandton Convention Centre, Johannesburg. How can I work with MC Pharma? Visit mcpharma.co.za/contact  or email pharmacist@mcpharma.co.za  for a complimentary regulatory-roadmap session. Contact MC Pharma for Your Pharmacovigilance Needs Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction What Is the eCTD? Why the eCTD Matters Inside an eCTD Dossier SAHPRA’s Current Rules Six Common Pitfalls & Quick Fixes How MC Pharma Makes It Easy Eight Key Take-aways FAQs References Introduction The Electronic Common Technical Document ( eCTD ) is now the universal format for medicine dossiers. South Africa’s regulator, South African Health Product Regulatory Authority , requires all medicine & health product applications, variations and renewals to be uploaded via its eCTD Portal from 2024 onwards ( ectd.sahpra.org.za ). Mastering eCTD management is therefore essential for local approval—and for leveraging the same dossier in other markets. What Is the eCTD? The eCTD is the digital, hyper-linked version of the CTD defined by ICH M8 . It places every quality, non-clinical, clinical and administrative file in a fixed folder tree and links them through an XML “table of contents” backbone ( ICH ,  ICH Admin ). Regulators open that XML and click bookmarks to reach any page instantly—no paper, no couriers. Why the eCTD Matters Benefit Advantage for applicants Evidence Global acceptance One core dossier serves FDA, EMA, SAHPRA and 20 + other agencies EFPIA white paper ( EFPIA ) Faster reviews Searchable PDFs; no shipping delays SAHPRA Q&A & Portal ( ectd.sahpra.org.za ,  SAHPRA ) Built-in validation Software flags naming, link or PDF errors before submission SAHPRA Module 1 spec v3.1 ( ectd.sahpra.org.za ) Lifecycle clarity Updates arrive as numbered “sequences” regulators can track ICH eCTD spec 3.2.2 ( ICH ) Inside an eCTD Dossier Module Core content 1 – Regional (ZA) eCTD-1 form, GMP/CPP certificates, PI/PIL, cover letter, etc. ( ectd.sahpra.org.za ) 2 – Summaries Quality Overall Summary, clinical & non-clinical overviews and regional information 3 – Quality Full CMC data: composition, specs, stability and regional specific information 4 – Non-clinical Animal pharmacology & toxicology reports 5 – Clinical Human-trial reports, statistics & post-marketing safety data Each update is a sequence  that adds, replaces or deletes files while preserving dossier integrity ( ICH Admin ). SAHPRA’s Current Rules Mandatory Portal  – All orthodox and biological medicines must be filed via SAHPRA’s eCTD Portal; paper and NeeS are no longer accepted ( ectd.sahpra.org.za ) . ZA Module 1 v3.1 (Mar 2024)  – Follow SA-specific folder names, envelope XML and validation checklist ( ectd.sahpra.org.za ). Pre-submission validation  – Submissions failing automated checks are rejected before scientific review. Baseline conversions  – Legacy paper/NeeS dossiers need a one-off sequence 0000 before any further variation. Six Common Pitfalls & Quick Fixes Pitfall Rapid fix Source 1. Un-bookmarked or scanned PDFs Use searchable templates; add bookmarks before compile ClinReg article ( Clinreg Partners ) 2. Broken hyperlinks Validate links in an eCTD viewer; avoid absolute paths ClinReg article ( Clinreg Partners ) 3. Wrong sequence numbers Keep a dossier log; always build from the last approved sequence WAYS PS blog ( WAYS ) 4. XML envelope errors Use ePublishing software that auto-generates ZA envelope fields SAHPRA spec v3.1 ( ectd.sahpra.org.za ) 5. Portal upload failures Test a small file early; upload in business hours; keep help-desk details handy SAHPRA Q&A ( SAHPRA ) 6. Resource & training gaps Outsource to experts or arrange staff training on eCTD tools WAYS PS blog ( WAYS ) How MC Pharma Makes It Easy Turn-key compilation  – We convert, hyperlink and publish a compliant zip that passes SAHPRA validation first time. Pre-flight checks  – >400 automated rules verify PDF versions, MD5 hashes and filenames. Lifecycle management  – We track every sequence from registration to annual retention, variations and updates. Cross-market rollout  – MC Pharma possesses expertise to develop customised dossiers from SAHPRA recognised reference authorities (RRA's) such as the EMA, Health Canada, MHRA, TGA, the FDA, for submission across a number of countries in Africa, thereby facilitating a wider market access. Training & rescue  – Need a quick fix for a rejected dossier? Our regulatory team can step in immediately. Contact our Regulatory Affairs unit to discuss timelines and costs. Eight Key Take-aways eCTD is mandatory  for human-medicine and health product filings to SAHPRA. One dossier, many markets  – global regulators accept the same core Modules 2–5. Faster approvals  – electronic navigation trims review time. Built-in quality checks  reduce refusals for technical reasons. Clear lifecycle view  lets regulators see every change sequence-by-sequence. SA-specific Module 1  must follow the March 2024 v3.1 spec. (Regional) Common pitfalls are avoidable  with validation, sequence tracking and trained staff. MC Pharma offers end-to-end support , saving time, budget and stress. Frequently Asked Questions (FAQ) What is the eCTD?   A standard, hyper-linked electronic dossier accepted by most regulators worldwide. Is it mandatory in SA?   Yes—SAHPRA requires eCTD for all new submissions, variations and renewals ( ectd.sahpra.org.za ,  SAHPRA ) . Typical file size per sequence? Variations: a few MB; new registrations with study reports: 1–3 GB. Can I re-use my SA dossier for FDA? Yes—swap in the US Module 1; Modules 2-5 remain unchanged. MC Pharma baseline timeline? Two to four weeks, depending on document quality and volume. References ClinReg Partners. (2024, 26 December). Navigating the challenges of eCTD submissions: What to look for and how to overcome pitfalls .   https://www.clinregpartners.com  (Clinreg Partners) EFPIA eCTD Subgroup. (2021, 20 December). Global ICH eCTD adoption (white paper) .   https://www.efpia.eu  ( EFPIA ) International Council for Harmonisation. (n.d.). Electronic Common Technical Document specification v3.2.2 .   https://ich.org  ( ICH ) South African Health Products Regulatory Authority. (2024, March 11). ZA-SAHPRA eCTD specification v3.1 .   https://ectd.sahpra.org.za  ( ectd.sahpra.org.za ) South African Health Products Regulatory Authority. (2024, October 25). RIMS communication – eCTD Module 1 update .   https://www.sahpra.org.za  ( SAHPRA ) WAYS Pharmaceutical Services. (2024). The complexity of eCTD compliance: Common challenges and practical solutions .   https://www.waysps.com  ( WAYS ) SAHPRA. (n.d.). eCTD Submissions Portal .   https://ectd.sahpra.org.za  ( ectd.sahpra.org.za ) Contact MC Pharma for Your eCTD Needs Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction What is a NAPPI Code? Code Structure & Format Governance & Stakeholders Application Process & Timelines Benefits of Accurate Coding Common Pitfalls & How to Avoid Them MC Pharma's Support Services Practical Example Frequently Asked Questions References Introduction NAPPI  codes (National Pharmaceutical Product Index identifiers)  underpin every private-sector reimbursement claim in South Africa. Each seven-digit code, first six digits for the product, last three for the pack size, enables seamless electronic data exchange between manufacturers, pharmacies, funders and hospitals. Custodied by MediKredit and governed through the NAPPI Advisory Board, the system has been the single accepted product standard since the early 1990s. This article demystifies code structure, application pathways, common pitfalls, and shows where MC Pharma fits into the process from dossier compilation to medical-scheme engagement. What Is a NAPPI Code? A NAPPI code is a unique identifier for any pharmaceutical, surgical, medical-device or healthcare consumable product in South Africa’s private sector. The code facilitates price adjudication , stock control, claims switching and supply-chain analytics. NAPPI is the only product code recognised by all medical schemes and administrators when processing claims. Code Structure & Format Seven digits split 6-3   – the first six digits denote the specific product, while the last three digits indicate pack size (e.g., 712719-001). No therapeutic meaning  – unlike ATC or GMDN, the digits are purely numeric and sequential; therapeutic class is captured separately in pricing files. Governance & Stakeholders Entity Role MediKredit Allocates and maintains the master NAPPI file; publishes a daily public-domain extract. NAPPI Advisory Board (NAB) Industry forum of schemes, hospitals and clinicians providing oversight. Council for Medical Schemes (CMS) Issues guidance on correct coding for claim funding. Application Process & Timelines Determine eligibility  – only the local manufacturer or authorised importer may apply. Compile application pack  – This pack includes completed application form together with Ridout information such as PIL/PI, Artwork, price incl. and excl. VAT and more. Submit to MediKredit  – Submit the forms/documents and fee payable to MediKredit. NAPPI codes are usually issued within ten working days for straightforward items. Discovery / scheme review  – funders run health-technology assessments before confirming reimbursement; expect 6–10 days for surgical items and up to six months for novel technologies. Public-domain listing  – once approved, the code appears in the daily NAPPI file, enabling pharmacies to dispense and claim. Benefits of Accurate Coding Faster reimbursement  – correct codes prevent claim rejections and cash-flow delays. Transparent pricing   – uniform identifiers allow schemes to benchmark and manage reference-price lists. Regulatory data harmony  – NAPPI integrates with SAHPRA registration numbers and GMDN descriptors, streamlining audits. Common Pitfalls & How to Avoid Them Wrong pack digit trio  – mismatching pack size digits leads to pricing mismatches; always verify against the MediKredit search facility. Unregistered importer  – only the product’s legal holder may apply; third-party applications are rejected. Assuming automatic reimbursement  – a code enables billing but does not guarantee scheme funding; negotiate formularies separately. Contact our Regulatory Affairs unit to discuss how to avoid pitfalls. MC Pharma’s Support Services Gap analysis  – cross-check dossier, pricing and clinical evidence against NAB (NAPPI® Advisory Board) and Discovery requirements. Application drafting  – prepare NAPPI forms, documents that need to be attached and pricing spreadsheets. Scheme liaison  – engage PBM teams to secure formulary listing and agreed reference prices. Life-cycle maintenance  – monitor annual price-increase submissions and pack changes. Practical Example When FUTURELIFE ® Smart food™ (500 g) obtained NAPPI 712719-001 it became claimable under certain scheme rules, but reimbursement still depends on plan type and savings available. Frequently Asked Questions (FAQ) Who assigns NAPPI codes?   MediKredit Integrated Healthcare Solutions is the sole custodian and issuing authority. How long does it take to get a code?   Straightforward “me-too” items are typically coded within ten working days, while novel technologies may take longer due to funder HTA review. Do NAPPI codes guarantee reimbursement? No. A code enables electronic claims but each medical scheme decides whether—and at what rate—to fund the product. Can distributors apply on behalf of manufacturers? Only the local manufacturer or authorised importer (the highest authority in the supply chain) may lodge an application. What happens if my pack size changes? You must apply for a new three-digit pack suffix; using the wrong suffix will cause claim rejections. References Council for Medical Schemes. (2024). CMScript 10: Coding and funding of claims . ( medicalschemes.co.za ) Discovery Health. (2025). NAPPI code registration and review process 2025  [PDF]. MediKredit. (2024). NAPPI® – Products & Services page . ( medikredit.co.za ) MediKredit. (2024). NAPPI® code allocation policies and processes . ( medikredit.co.za ) National Pharmaceutical Product Index. (2024, 15 Feb). Wikipedia entry . ( en.wikipedia.org ) Competition Commission of South Africa. (2019). Health Market Inquiry submission – MediKredit  [PDF]. ( compcom.co.za ) Futurelife®. (2025). Certification – NAPPI code  page. ( futurelife.co.za ) Petsana, V. (2025, Jun). The NAPPI® system: South Africa’s unsung hero in healthcare  [LinkedIn Article]. ( linkedin.com ) MediKredit. (2025). NAPPI® search facility . ( medikredit.co.za ) Need assistance preparing your NAPPI application? Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction What is an SmPC and Why Does Compliance Matter? Global Regulatory Framework SmPC Structure at a Glance Compliance Life-Cycle Frequent Deficiencies & How to Avoid Them MC Pharma’s SmPC Compliance Services References Frequently Asked Questions Introduction to The Summary of Product Characteristics (SmPC) The SmPC is a critical, scientific, regulator-approved document that defines every authorised medicine’s benefits, risks and conditions of use. The SmPC is synonymous with the South African Professional Information (PI) leaflet which is regulated in terms of Regulation 11 of Act 101/1965 (The Medicines and Related Substances Act).   The SmPC follows the format stipulated by the European Medicines Agency (EMA) Directive 2001/83/EC (2025). What is an SmPC and Why Does Compliance Matter? The SmPC is a critical (and legal) part of the registration application for every medicine. It is an integral part of the registration application and is presented in Module 1.3. of the Common Technical Document (the CTD).  The SmPC must be aligned and referenced against CTD Modules 2 -5 and SAHPRA’s Guidelines. The SmPC is subject to review and registration approval by SAHPRA.  It serves as the master document upon which patient leaflets and promotional claims are based. Non-compliant SmPCs will result in regulatory findings or even rejection of the medicine’s application. Global Regulatory Framework South Africa & SADC & the WHO SAHPRA adopts a tripartite model: SmPC (called the package insert), patient leaflet and outer labelling, aligned with a 13-section structure derived from EU rules. ( sahpra.org.za ). The WHO promotes reliance, harmonisation, and SmPC alignment across regions like SADC, EAC, and ZAZIBONA The European Union Directive 2001/83/EC (Article 11) lists the mandatory headings and legal status of the SmPC. ( eur-lex.europa.eu ) EMA’s Quality Review of Documents (QRD) template  sets standard wording ; v11 is now in public consultation (deadline 31 Aug 2025). The upcoming ePI system ( electronic Product Information) is a digital, standardised version of the SmPC, PIL (Patient Information Leaflet), and labelling—structured in machine-readable XML format instead of traditional PDFs or Word files. This XML format will allow for: Searchable and filterable content Integration into electronic health records (EHRs) Automated updates Accessibility for mobile and web applications SAHPRA has not yet aligned to the ePI, and may adopt similar digital standards over time . The United Kingdom The MHRA retains the EU QRD headings but applies its own labelling and packaging best-practice guidance post-Brexit. ( gov.uk ,   assets.publishing.service.gov.uk ) Approved UK SmPCs are published on the MHRA Product Information Portal. SmPC Structure at a Glance The SmPC Structure is  based on the EMA QRD template , widely adopted and adapted by SAHPRA and many WHO-aligned regulatory authorities: Section Title Purpose “Scheduling Status” to appear above Section 1 1 Name of the Medicinal Product Name, strength & dosage form 2 Qualitative and Quantitative Composition API content & excipients of known effect 3 Pharmaceutical Form Description (e.g., tablet, solution) & appearance 4.1 Therapeutic Indications Approved medical uses 4.2 Posology and Method of Administration Dosing regimen & administration instructions 4.3 Contraindications Conditions or factors that prohibit use 4.4 Special Warnings and Precautions for Use Key safety risks and precautions 4.5 Interaction with Other Medicinal Products and Other Forms Known or expected drug interactions 4.6 Fertility, Pregnancy, and Lactation Use considerations in these groups 4.7 Effects on Ability to Drive and Use Machines Safety information regarding psychomotor skills 4.8 Undesirable Effects (Adverse Reactions) Side effects with frequencies 4.9 Overdose Signs, symptoms, and management 5.1 Pharmacodynamic Properties Mechanism of action & therapeutic class 5.2 Pharmacokinetic Properties ADME profile (Absorption, Distribution, Metabolism, Excretion) 5.3 Preclinical Safety Data Toxicology and safety in animals 6.1 List of Excipients All non-active ingredients 6.2 Incompatibilities Known incompatibilities with other substances 6.3 Shelf Life Duration of product stability 6.4 Special Precautions for Storage Storage conditions (e.g., refrigeration) 6.5 Nature and Contents of Container Packaging material and configuration 6.6 Special Precautions for Disposal Safe disposal and handling instructions 7 Marketing Authorisation Holder (MAH) Name and address 8 Marketing Authorisation Number(s) Regulatory reference numbers 9 Date of First Authorisation/Renewal Historical regulatory data 10 Date of Revision of the Text Last update to SmPC 11 Dosimetry   (radiopharmaceuticals only) Radiation exposure details Compliance Life-Cycle SmPC (or Professional Information/PI in SAHPRA terms) compliance is not static—it's a life-cycle obligation that spans from product development to post-marketing. Here’s a structured view of the key compliance aspects throughout the SmPC life-cycle: Initial Registration & Approval SmPC must be technically validated and complete at submission. SAHPRA requires the SmPC (PI) to form the basis for the PIL. Scientific, unambiguous, and non-promotional language is mandatory. Excipient listings, shelf life, dosage forms, and manufacturer details must match other dossier modules. Post-Registration Maintenance (Variations & Updates) SmPC must be updated to reflect new safety data (e.g. pharmacovigilance, clinical literature). All clinical and safety updates (new indications, contraindications, adverse effects) require Type II variation applications. For reliance-based submissions, SmPC updates must align with recognised reference authorities. Renewals & Retention Renewal submissions must confirm that the SmPC remains current and accurate. Retention Requirements Retention of registration every five years includes compliance check of SmPC accuracy and consistency. Pharmacovigilance-Linked Obligations Adverse event trends must trigger updates in SmPC Section 4.8 (Undesirable Effects). Risk Management Plans (RMPs) Must inform and align with SmPC content (e.g. Section 4.4: Warnings and Precautions). Frequent Deficiencies & How to Avoid Them Deficiency Possible Root Cause Fix Safety class warnings missing Copy/paste from originator PI without updates or incorrect references used Requires a detailed review and a line-by-line gap analysis against the reference SmPC. Mis-aligned SPC/PIL text Different persons working of the document and no final document checks or validation. Maintain single‐source master documents and references in RIM tools Cross-referenced non-existing studies Poor document control List only peer-reviewed or regulator-accepted references.  MC Pharma’s SmPC Compliance Services Medical writing & SmPC authoring  – drafting de-novo or generic SmPCs against SAHPRA templates and guidelines. Regulatory gap analysis  – identifying wording misalignments and reference to approved Reference materials. Variation strategy  – classifying the variations and preparing the application and submission package Life-cycle maintenance  – continuous surveillance of literature and safety data to trigger timely updates. Frequently Asked Questions (FAQ) What is the legal status of an SmPC?   It is part of the marketing authorisation and its wording is legally binding. Do SAHPRA and EMA use the same headings? Yes – SAHPRA mirrors the EU QRD headings with minor local tweaks. When is a Type II variation required? For major safety or efficacy updates, new indications, posology changes, or new safety and efficacy data. How long does a Type IB variation take? 30 + 7 working days clock-in-hand, plus clock-stops if questions arise. Can marketing claims exceed the SmPC? No – promotional materials cannot go beyond the SmPC wording. How does MC Pharma support SmPC updates? We classify the variation, draft the updated text, submit through e-submission portals and track approval. Is the SmPC the same as the patient leaflet? No – the SmPC is for healthcare professionals; the PIL is derived from it for patients. References European Medicines Agency. (2025). Product-information (QRD) templates – draft v11 . ( ema.europa.eu ) European Medicines Agency. (2023). Electronic product information (ePI) pilot page . ( ema.europa.eu ) European Medicines Agency. (2024). ePI pilot report – lessons learned . ( ema.europa.eu ) European Medicines Agency. (2024). Assessment guide for SmPC Section 5.1 . ( ema.europa.eu ) European Commission. (2024). Draft Variations Classification Guideline . ( health.ec.europa.eu ) European Commission. (2009). Guideline on the SmPC (EudraLex Vol 2C) . ( health.ec.europa.eu ) Directive 2001/83/EC of the European Parliament and Council. (2001). Community code relating to medicinal products for human use . ( eur-lex.europa.eu ) Medicines and Healthcare Products Regulatory Agency. (2020). Best-practice guidance on labelling & packaging . ( assets.publishing.service.gov.uk ) GOV.UK . (2024). Medicines: Packaging, labelling and PIL  (MHRA overview). ( gov.uk ) Royal Pharmaceutical Society. (2025). Overview of SmPCs for trainee pharmacists . SAHPRA. (2022). Clinical Evaluation Guideline (SmPC equivalent) . ( sahpra.org.za ) SAHPRA / SADC. (2019). Draft Guideline on Product-Information & Labelling . ( sahpra.org.za ) World Health Organization. (2024). Contents & structure of a WHOPAR . ( extranet.who.int ) EMA PLM Portal. (2024). ePI user guide for applicants . ( plm-portal.ema.europa.eu ) Need a gap analysis or XML conversion for your next SmPC submission? Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction Registered Medicine vs Medical Device The Acid Test of Whether A Product Is A Medicine or Medical Device Registration as A Medicine | Classification of A Device Current Registration Requirements For The Product Registration Call-Up Plan For Medical Devices Borderline Products (Ref SAHPRA Guideline 2.45) Bonusing and Sampling – Sections 18A and 18B of Act 101/1965 SEP (Single Exit Pricing) Advertising Restrictions General Legislation of Application: Consumer Protection Act (No 68 of 2008): A Measure of Risk Summary - In Terms of Current Regulations Frequently Asked Questions References How MC Pharma Provides Services & Consulting Introduction The purpose of this communication is to help you differentiate important aspects that define what is a registered medicine and what is a combination medical device. Medical Device regulation and registration in South Africa and in fact Southern Africa is in its infancy and product registration policies are still being developed by the Regulators in these regions. This summary of regulatory requirements and conditions is a motivation in support of registered medicines and prepared in defense of routine therapeutic substitution of a combination medical device for a registered medicine. We argue that a registered medicine, with reference to its therapeutic indication, cannot be routinely substituted with a combination medical device. Registered Medicine vs Medical Device Let's Start With Definitions – Refer Act 101/1965: Definition of A Medicine (a) means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in— (i) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in humans; or (ii) restoring, correcting or modifying any somatic or psychic or organic function in humans. Definition of A Medical Device Means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, ..[…] (b) which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means; The intention of medical devices are for one or more of the following: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy or of a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices; or providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body. which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means. The Acid Test of Whether A Product Is A Medicine or Medical Device The acid test of whether something is or is not a medical device or an IVD is: what is it used for and how does it work? The "how" is important because for something to be a medical device, it cannot achieve its primary intended action by pharmacological, immunological or metabolic means (so a medical device is not a drug or vaccine, for instance). These processes could support the intended functioning of a medical device but would not be the main activity. This narrows down the possibilities somewhat, but the potential range is still extremely wide. If the function of an instrument, apparatus, implement, machine, implant, software and the like is intended by the manufacturer to diagnose, prevent, monitor, treat or alleviate disease, then it is a medical device. If it is intended to diagnose, monitor, treat, alleviate or compensate for an injury, it is a medical device. The same applies if it is intended to control conception, disinfect medical devices, or support or sustain life. It is also a medical device if it is meant to investigate, replace, modify or support the anatomy or a physiological process. All in all, the definition of a medical device is so wide that it has some industry watchers wondering whether it includes devices such as fitness trackers, which measure the wearer's personal fitness by monitoring various factors such as heart rate, steps walked, and calories consumed. Chances are that such items are not medical devices as long as they only provide data for the edification of the wearer. If used for any form of diagnostics or treatment, however, then it arguably crosses the line into medical device or IVD territory. An item that almost certainly is a medical device is a blood-glucose monitor that people with diabetes might use to inform them when to take their medication. Another example is an app that sends an emergency signal in the event of a stroke, heart attack or other health crisis. Registration as A Medicine | Classification of A Device Medicines in South Africa are subject to a system of scheduling on the basis of the active pharmaceutical ingredients that they contain. The primary consideration in scheduling a substance is its safety profile, in relation to the therapeutic indications for its use. Devices are a self-assessment by the licensed Applicant based upon a set of classification rules supplied by the Regulatory Authority, based on: the manufacturers or distributor’s intended use of the device or IVD; level of risk to patients, users and other persons (the probability of occurrence of harm and the severity of that harm); degree of invasiveness in the human body; and duration of use and exposure. The Regulatory Authority has the responsibility and authority to determine the final classification. According to SAHPRA Guidelines medical devices are classified into the following four risk classes, determined according to published classification rules: Class A – Low Risk Class B – Low-Moderate Risk Class C – Moderate-high Risk Class D – High Risk Where risk relates to the patient, user or to public health. The highest risk devices are those that are implantable or invasive and are used in the long term. Current Registration Requirements For The Product Registered Medicine Medicines are required to be fully registered with SAHPRA (South African Health Products Authority) before they are authorized for sale in South Africa. The SAHPRA registration process includes a scientific review of all aspects of quality, safety and efficacy for the product and marketing authorization is conditional on the Applicant meeting the strict SAHPRA Licensing standards for all partners in the supply chain, including Licensed Distributors/Wholesalers. The conditions of registration also include stringent product quality management control, such as pharmacovigilance, post-importation quality analysis, validation of transportation, on-going stability testing, the provision of product quality review reports etc. Medical Device At this moment, there is no registration procedure for medical devices – this is still in development with a call-up program imminent, based upon a risk assessment – which means that Class D medical Devices will be called up first. Registration Call-Up Plan For Medical Devices Although, the Medicines Act and General Regulations provides for the above, SAHPRA’s registration process is currently in development. To ensure its mandate that medical devices are safe, effective and of good quality, when SAHPRA registers medical devices, it must "call-up" specific products or product classes for registration by publishing a call-up notice in the Government Gazette. A draft call-up plan outlines the steps involved in this process. It explains that SAHPRA will use a risk-based approach in calling up medical devices for registration, prioritising the registration of more risky products and products of public health importance. Product call-ups will cover medical devices that are already on the market in South Africa as well as new medical devices that are being introduced. In the absence of medical device registration, SAHPRA has established several "quasi-registration" requirements as part of its medical device establishment licensing processes to enable oversight and control of medical devices used in South Africa. In March 2024, SAHPRA invited the industry to submit an Expression of Interest (EOI) to take part in a Feasibility Study (NOT PILOT STUDY) for the registration of medical devices. Borderline Products (Ref SAHPRA Guideline 2.45) “ Health products which cannot be classified as either a pharmaceutical, medical device, cosmetic, food supplement, or biocidal product because they are indistinguishable from one another are referred to as "borderline" products until SAHPRA determines their categorisation status and assigns them to a specific regulatory pathway. SAHPRA issued a [Borderline] guideline in 2017 to provide applicants with recommendations regarding the registration of borderline and combination products. However, the guideline, which proposes the framework discussed below, has not yet been finalised.” Determination of whether a product is a Medicine or Medical Device will consider the following: The primary mode of action (PMOA) means “the single mode of action of a borderline product that provides the most important therapeutic action of the borderline product.” The most important therapeutic action is the mode of action expected to make the greatest contribution to the overall intended therapeutic effect(s) of the borderline product. The claimed effect or purpose must be achieved by the most important therapeutic action. Where the primary intended mode of action is achieved by pharmacological, immunological or metabolic means, in or on the human or animal body, the borderline product is designated to be a medicine: Immunological  – understood as an action in or on the body by stimulation and/or mobilisation of cells and/or products involved in a specific immune reaction. Metabolic  – understood as an action which involves an alteration of the normal chemical processes participating in, and available for, normal body function. The fact that a product is itself metabolized does not imply that it achieves its principal intended action by metabolic means. Pharmacological  – understood as an interaction between the molecules of the substance in question and a cellular constituent, usually referred to as a receptor, which either results in a direct response, or which blocks the response to another agent and, for the purposes of this policy, includes anti-infective activity. Where the primary intended mode of action is achieved by pharmacological, immunological or metabolic means, and the action occurs in vitro, without reintroducing a modified cellular substance to the patient, the product will be designated to be a medical device. Where the primary intended mode of action by which the claimed effect or purpose is not achieved by pharmacological, immunological, or metabolic means, but may be assisted in that effect or purpose by pharmacological, immunological, or metabolic means, the borderline product (including a combination product) will be designated to be a medical device. A borderline product may be classified as a medicine or a medical device, even when no explicit therapeutic claim is made. A therapeutic claim may also be implicit. Both types of claims are considered when a product is classified. Explicit claims are stated with no ambiguity with regard to their meaning or intent. In contrast, implicit claims made in the representation of a product indirectly suggest a therapeutic benefit. Product representation includes the appearance, labelling, and advertising of a product. In the absence of either an explicit or implicit claim, a product may be classified (e.g., as a medicine or a medical device) if the intrinsic properties of the product are such that there is no other possible use. For example, acetaminophen (paracetamol) has no other use but as a medicine, so the absence of a claim will not change its classification as a medicine. In addition to the primary mode of action – the composition and form of the product and the therapeutic effect of the product may be considered to assist in the designation of the product. The composition and form of a product may help to distinguish a medicine from a medical device. A medical device exhibits structure in its final therapeutic form, that is, the structure of the product when it is achieving its effect. With a medical device, its structure contributes directly to its effect. In contrast, the physical structure of a medicine (that is, in its dosage form, such as a tablet or an ointment, not its chemical structure) does not usually contribute directly to its therapeutic effect. Consideration is also given to the therapeutic effect of a product and how this effect is achieved. In Act 101, as amended, the definition of a medicine and medical device differ respectively in whether a product is used to restore, correct or modify any somatic or psychic or organic function (as with a medicine) OR treat or alleviate a disease; treat, alleviate or compensate for an injury, or modify or support of the anatomy or of a physiological process (as with a medical device). Bonusing and Sampling – Sections 18A and 18B of Act 101/1965 Registered Medicine 18A. Bonusing:  Prohibits the supply of any medicine, medical device or IVD according to a bonus system, rebate system or any other incentive scheme. 18B. Sampling:  Prohibits sampling of any medicine, medical devices or IVD. “For the purposes of this section ‘sample’ means the free supply of products, medical devices or IVDs by a device or IVD establishment, manufacturer or wholesaler or its agent to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974.” This includes consignment stock. Medical Device Although Medical Devices are referred to in Sections 18A and 18B of Act 101/1965, Medical Devices currently have a temporary exemption from these sections in the Act, by means of a three-year Section 36 exemption notice. SEP (Single Exit Pricing) The Medicines Act provides for a transparent pricing system which incorporates a single exit price (SEP) for medicines and scheduled substances. The SEP is the price at which manufacturers (including importers) are required to sell medicines and scheduled substances to anyone other than the government. A pharmacy, wholesaler, distributor, or any person licensed under the Medicines Act is prohibited from selling a drug for more than the prescribed SEP. However, pharmacists may charge an appropriate dispensing fee based on the recommendations of the Pricing Committee. This is, however, regulated by Section 22C of the Medicines Act. Registered Medicine Applicable to Medicines - The pricing breakdown of medicines is transparent and is regulated. These prices are published on the Department of Health website. Annual increases are pre-set and pre-determined and published annually in the Government Gazette. Only one SEP increase is permitted annually. Medical Device Currently and temporarily not applicable to Medical Devices – temporary exemption granted. Medical Device prices may be fluctuated and changed according to market needs. There are no regulatory restrictions on the pricing of Medical Devices. Advertising Restrictions Registered Medicine S2 to S4 may only be advertised to the healthcare professions. Medical Device Class D may only be advertised to the Profession.  Medical devices are not permitted to market in South Africa unless they are listed in the South African Medical Device Register. The CPA predominantly sets out the requirements for advertising and marketing of products and services (general, medical or otherwise). The CPA requires that the advertising and marketing of goods is to be done in a manner that is not reasonably likely to imply a false or misleading representation concerning those goods and is not misleading, fraudulent or deceptive in any way. With respect to claims, suppliers are warned in the CPA that strict liability will be imputed onto producers, importers, distributors or retailers of any goods on which inadequate instructions or warnings are provided to the consumer relating to any hazard arising from or associated with the use of the goods. General Legislation of Application: Consumer Protection Act (No 68 of 2008): A Measure of Risk In South Africa, product safety in general is governed by the Consumer Protection Act (No 68 of 2008) (the CPA). The CPA provides for the promotion of a fair, accessible and sustainable marketplace for consumer products and services and for that purpose, establishes national norms and standards relating to consumer protection, provides for improved standards of consumer information, prohibits certain unfair marketing and business practices, promotes responsible consumer behaviour, and promotes a consistent legislative and enforcement framework relating to consumer transactions and agreements. This consequently creates an obligation on suppliers of products (from the beginning to the end of a supply chain) to provide healthcare products and medical devices free of defects. The CPA imposes strict liability on producers or importers, distributors or retailers for any harm caused by a product (which would include medical devices) caused wholly or partly as a consequence of: supplying unsafe goods; a product failure, defect or hazard in any goods; or inadequate instructions or warnings provided to the consumer pertaining to any hazard arising from or associated with the use of any goods, irrespective of whether the harm resulted from any negligence on the part of the producer, importer, distributor or retailer, as the case may be. Summary - In Terms of Current Regulations: Medical Device establishments are required to be SAHPRA Licensed. There is no formal SAHPRA registration procedure for medical devices as yet. A Borderline Medical Device containing active chemical substances: does not achieve its primary intended action by pharmacological means/action. The pharmacological action of active ingredients in borderline medical devices is secondary and auxiliary to the primary indication of hemostasis. Medicine is supported by vast clinical studies, experience and knowledge that backs the brand as well as the medicinal registration status. Quality and Efficacy of Medicines throughout the distribution chain is assured by means of comprehensive Quality Management systems that are SAHPRA audited. These systems require validation throughout manufacturing, stability, transportation, post-importation quality analysis, Release procedures, distribution, marketing/sales and pharmacovigilance. Frequently Asked Questions (FAQ) What is the primary difference between a medicine and a medical device? A medicine achieves its primary intended action through pharmacological, immunological, or metabolic means, while a medical device achieves its main effect through physical or mechanical means, potentially supported by pharmacological action. How are medicines regulated in South Africa? Medicines must be fully registered with SAHPRA, undergo scientific review for quality, safety, and efficacy, and comply with strict licensing, pharmacovigilance, and supply chain quality standards. How does SAHPRA classify medical devices? Medical devices are classified into four risk-based categories — Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk) — based on intended use, invasiveness, duration of use, and potential risk to the patient. Is pricing regulated for medical devices in South Africa? No. Medical devices are exempt from single exit price (SEP) regulations, meaning their prices can vary based on market factors without regulatory restrictions. What is a borderline product? A borderline product is one that cannot easily be classified as a medicine, medical device, cosmetic, food supplement, or biocidal product. SAHPRA determines its classification based on its primary mode of action and intended purpose. References Bowmans. South Africa: Regulation of Medical Devices is Set to Become a Reality in SA , Julie Oppenheim, 30 September 2020. - https://bowmanslaw.com/insights/regulation-of-medical-devices-is-set-to-become-a-reality-in-sa/ MCC (SAHPRA) Guideline 2.45 on Borderline Products, March 2017. - https://www.mbac.co.za/wp-content/uploads/2019/10/2.45-Borderline_Products_Feb17_v1_for_comment.pdf  ( mbac.co.za ) Regulations Relating to Medical Devices and In-vitro Diagnostic Medical Devices (IVDs), Government Gazette No 40480, 9 December 2016 (Regulation 11(1)). URL (Gazette reference provided via SAHPRA site): https://www.sahpra.org.za/medical-devices/  ( SAHPRA ) Medical Devices and Consumer Health Products 2021; Fasken Law Practice, 31 August 2021. (No current URL found—this appears to be a law firm publication not indexed publicly.) SAHPRA publication; ITG Meeting update, November 2021. Status of Guideline 2.45 (Borderline Products) – Comments under review. (No direct URL located; likely internal or unpublished doc.) SAHPGL-MD-04_v5 – Guideline for Classification of MD and IVDs. URL: https://www.sahpra.org.za/document/guideline-for-classification-of-medical-devices-and-ivds/  ( SAHPRA ) Essential Principle Compliance – Medical_Device_IVD_Essential_Principles_Nov19_v2 . URL: https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-guidelines/  (link includes Essential Principles doc) ( SAHPRA ) GUIDELINE FOR MEDICAL DEVICE VIGILANCE: Adverse Events Reporting – SAHPGL-MD-03_v4. URL: https://www.sahpra.org.za/document/guideline-for-medical-device-adverse-event-reporting/  ( SAHPRA ) SAHPGL-MD-11_v1 – Guideline for Completing Medical Device Adverse Event Form. URL: https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-guidelines/  (the listing page includes MD‑11 doc) ( SAHPRA ) GLF-MD-11A_v1 – Medical Device Adverse Event Reporting Form. URL: https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-guidelines/  ( SAHPRA ) Guideline for Completing Medical Device Adverse Event Form – SAHPGL-MD-11_v1. Medical Device Establishment Licence Renewal Process. - https://www.sahpra.org.za/document/md031-medical-device-establishment-licence-renewal-process/  ( SAHPRA ) How MC Pharma Provides Services & Consulting As a licensed Marketing Authorisation Holder (MAH)  under Section 22C of the Medicines and Related Substances Act, MC Pharma offers end-to-end regulatory consulting and compliance support for both medicines and medical devices in South Africa. Our services include: Regulatory Affairs Consulting  – Guiding clients through SAHPRA requirements, classification, and registration strategies. eCTD Dossier Management  – Compilation, publishing, submission, and lifecycle management of regulatory dossiers. Pharmacovigilance  – Monitoring, reporting, and managing adverse events to ensure ongoing safety compliance. Borderline Product Support  – Assisting with classification assessments and preparing submissions for SAHPRA determination. Import & Export Logistics  – Managing compliant movement of medicines and devices across borders, including post-importation quality testing. Quality Management Systems  – Developing, implementing, and auditing QMS to SAHPRA standards. Why Choose MC Pharma? MC Pharma combines over 26 years of regulatory experience  with a deep understanding of the South African pharmaceutical and medical device landscape to deliver compliant, efficient, and market-ready solutions for local and international clients. 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website