Broad-Based Black Economic Empowerment Act (B-BBEE Act)
Act 53 of 2003
Provides the empowerment-compliance context often used in public-sector supplier evaluation.
Relevant because this is a South African public-sector procurement opportunity.
Issuing Organization
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITYLocation
Gauteng
Closed On
31 Mar 2026
Status: Closed — No Longer Accepting Submissions
This tender closed on 31 March 2026. Submissions are no longer accepted. The tender lifecycle continues — check the awards section for updates.
Tender Type
Request for Bid(Open-Tender)
Delivery Location
Loftus Park, Building A, 402 Kirkness St - Arcadia - Pretoria - 0083
Organization Type
GOVERNMENT
Published
08 Mar 2026
OCDS Reference
ocds-9t57fa-150205
Sahpra seeks a customizable off-the-shelf (cots) pharmacovigilance digitization solution to modernize its regulatory processes, including data collection, case management, signal detection, and reporting. The solution must support all health product categories (medicines, devices, veterinary, complementary) and integrate with global standards like e2b r3, meddra, and vigibase. The contract includes 36 months of maintenance and support with an option to renew for 24 months.
AI Document Analysis Stages
Request for Bid(Open-Tender)
Loftus Park, Building A, 402 Kirkness St - Arcadia - Pretoria - 0083
These references help suppliers understand the public-procurement framework around this opportunity. They are generated from the tender category, issuing organisation type and procurement context.
Bid Document-RFB006 _PHARMACOVIGILANCE DIGITIZATION SOLUTION.pdf
Date & Time
Tuesday, 31 March 2026 - 11:00
Venue
Link on the bid document
This briefing session took place during the tender period.
08 Mar
2026
Tender Published
Tender was published
31 Mar
2026
Closing Date
Tender closing date
Pending
Median Estimate
R 2 408 172
Range
Based on 25 comparable awarded tenders. Companies with similar profiles typically bid near the median.
* Estimates are based on historical data and do not guarantee actual award values.
We refine every tender document through these stages so you can brief your team and prepare your bid with confidence. Anything marked as "in progress" will be upgraded automatically — no action required from you.
AI Document Analysis Stages
We refine every tender document through these stages so you can brief your team and prepare your bid with confidence. Anything marked as "in progress" will be upgraded automatically — no action required from you.
Review in progress
The information shown on this card is preliminary. Our procurement team is currently finalising the submission guidelines, evaluation criteria, technical specifications, financial requirements, and compliance sections so you have a clean, bid-ready summary to work from. Document being finalised: Bid Document-RFB006 _PHARMACOVIGILANCE DIGITIZATION SOLUTION.pdf. You don’t need to refresh — this page will pick up the updated review automatically.
Important Dates
Source: Bid Document-RFB006 _PHARMACOVIGILANCE DIGITIZATION SOLUTION.pdfClosing date: 31 March 2026 at 11:00. Non-compulsory virtual briefing session: 12 March 2026, 11:00–12:00 via Microsoft Teams (link: https://teams.microsoft.com/meet/35227190612405?p=jrwIIiMN8UW37UdNXL; Meeting ID: 352 271 906 124 05; Passcode: BL9dB2Nr). Clarification queries deadline: 16 March 2026 (submit via email to [email protected]). Q&A responses published on SAHPRA website: 20 March 2026.
Contact Information
Source: Bid Document-RFB006 _PHARMACOVIGILANCE DIGITIZATION SOLUTION.pdfSCM contact for clarifications: Precious Mnguni, Email: [email protected]. Submission address: Loftus Park, Building A, 402 Kirkness St, Arcadia, Pretoria, 0083 (2nd floor, office hours 08:30–16:00).
Submission Guidelines
Source: Bid Document-RFB006 _PHARMACOVIGILANCE DIGITIZATION SOLUTION.pdfSubmit 1 original + 2 copies + 1 USB in a sealed envelope. Envelope must be marked with: bid number (SAHPRA/2026/PHARMACOVIGILANCE DIGITIZATION SOLUTION/RFB006), closing date/time (31 MARCH 2026 @ 11:00), and bidder’s name/address. Deliver to: Loftus Park, Building A, 402 Kirkness St, Arcadia, Pretoria, 0083. Deposit into tender box or hand in at 2nd floor during office hours (08:30–16:00, Mon–Fri). No posted, faxed, or emailed bids accepted. Late bids (even 1 second after 11:00) will be returned unopened. Official time source: Telkom (dial 1026). Bid validity: 90 days from closing date. Documents submitted on time will not be returned. Accept General Conditions of Contract (download from Treasury: http://www.treasury.gov.za/divisions/ocpo/sc/GeneralConditions/General%20Conditions%20of%20Contract.pdf).
Evaluation Criteria
Source: Bid Document-RFB006 _PHARMACOVIGILANCE DIGITIZATION SOLUTION.pdfEvaluation follows a 80/20 preference point system: Price 80 points, Specific Goals (B-BBEE) 20 points. Total scoring: 100 points (Functionality 40, Presentation 40, Price/Specific Goals 20). Compliance with minimum requirements is mandatory. Bids must meet all stipulated conditions to proceed to evaluation. Evaluation stages: 1) Compliance check (mandatory requirements), 2) Functional/technical assessment (40 points), 3) Presentation/clarity (40 points), 4) Price and preference points (20 points).
Technical Specifications
Source: Bid Document-RFB006 _PHARMACOVIGILANCE DIGITIZATION SOLUTION.pdfScope: Implement a Pharmacovigilance digitization solution (part of RIMeS ecosystem) with 36-month maintenance/support and option to renew for 24 months. Must include: COTS software customization, training (ToT), user manuals, and ongoing technical support. Functional requirements: 1) Data Collection: Multi-source (HCPs, patients, manufacturers, clinical trials, etc.) via mobile/web; support E2B R3, FDA3500A, IMDRF, VEDDRA, TGA formats; structured data entry with controlled vocabulary (IDMP, MedDRA, WHO-DD, VEDDRA). 2) Case Management: Triage, data quality review, assessment (seriousness, causality), workflow tracking, notifications, escalations. 3) AI Capabilities: Auto-coding (MedDRA, WHO-DD), narrative writing (NLP/ML), translation, trend analysis, image interpretation, document parsing (OCR/NLP). 4) Product/Event Dictionaries: Manage health products, substances, admin routes, MedDRA, IMDRF/UDI, VEDDRA. 5) Signal Detection: Biostatistical algorithms (PRR, ROR, EBGM, BCPNN, etc.) for all product types (orthodox, biological, medical devices, IVDs, veterinary, complementary). 6) Aggregate Reporting: Dashboards, configurable queries, templated reports (DSUR, PADER, CIOMS II), data filtering. 7) Vigilance Activities: PI/PIL, DHCPL, risk management plans, PSUR/PBRER, PV inspections, PSMF, QPPV info. 8) Regional Decentralization: Isolate ICSRs/data by region with access controls. 9) Interoperability: REST APIs (VigiMobile, MedSafety), MedDRA/SNOMED, WHO-DD, AMA, NDOH/NHI, IMDRF, VigiBase. Non-functional: Cloud hosting (SOC-3, ISO9001/27001, POPIA-compliant), security (GxP, CFR 21 Part 11, EU Annex 11), usability (PWA, multi-language, audit trails, e-signatures), performance (minimal latency). Modular implementation: Base platform (Modules 1–6) for all health product categories, with veterinary phase-in. Maintenance: 36-month Tier 3 support.
Financial Requirements
Source: Bid Document-RFB006 _PHARMACOVIGILANCE DIGITIZATION SOLUTION.pdfPricing: 80/20 preference point system (Price 80, Specific Goals 20). Total scoring: 100 points (Functionality 40, Presentation 40, Price/Specific Goals 20). Pricing schedule must be completed per Section B 5 (SBD 3.1) and included in sealed bid. Breakdown required: modular costing for base platform (Modules 1–6) and per health product category (orthodox/biological, medical devices/IVDs, veterinary, complementary). Include data standardization support (up to 60 hours/category). Detail project milestones, payment points, and modular approach. Maintenance/support costs for 36 months (Tier 3) must be itemized. No posted/email bids accepted; all pricing documents must be submitted physically with bid.
Compliance Requirements
Source: Bid Document-RFB006 _PHARMACOVIGILANCE DIGITIZATION SOLUTION.pdfMandatory compliance: Prevention and Combating of Corrupt Activities Act adherence. B-BBEE: Preference points (20) awarded per Preferential Procurement Regulations, 2022 (SBD 6.1 form required). Bid documents must include: SBD 1 (Invitation to Bid), SBD 4 (Declaration of Interest), SBD 6.1 (Preference Points Claim). Accept General Conditions of Contract (GCC). All bids must be originally signed in ink or certified copies. Documents must be stamped and signed by a commissioner of oaths where required. Bid validity: 90 days from closing date.
Tenders in this industry often require registration with these bodies.
Recommended Certifications
Having these can improve your winning chances: CA(SA) - Chartered Accountant, PMI-PMP (Project Management Professional), Prince2 Practitioner, Six Sigma Certification
These rules commonly apply to South African public-sector procurement.
Act 53 of 2003
Provides the empowerment-compliance context often used in public-sector supplier evaluation.
Relevant because this is a South African public-sector procurement opportunity.
Act 108 of 1996 (s217)
Sets the constitutional standard for fair, equitable, transparent, competitive and cost-effective public procurement.
Relevant because this is a South African public-sector procurement opportunity.
Act 5 of 2000
Covers preferential procurement and preference-point systems used in public tenders.
Relevant because this is a South African public-sector procurement opportunity.
Act 12 of 2004
Supports anti-corruption controls and supplier integrity in procurement processes.
Relevant because this is a South African public-sector procurement opportunity.
Act 28 of 2024
Provides the national framework for public procurement across government.
Relevant because this is a South African public-sector procurement opportunity.
Act 2 of 2000
Supports access to tender records, award decisions and public-sector procurement information.
Relevant because this is a South African public-sector procurement opportunity.
Act 3 of 2000
Supports lawful, reasonable and procedurally fair administrative tender decisions.
Relevant because this is a South African public-sector procurement opportunity.
This is general procurement context, not legal advice. Always verify requirements in the official tender documents and issuing authority notices.
To download these documents and access AI-powered analysis, visit the main tender page.
Awaiting Award of Contract
This tender has not yet been awarded. The contracting authority is expected to publish the award notice in due course.
31 Mar
2026
Submissions Closed
No further submissions were accepted after this date.
The Department of Health leads national health policy and supports provincial health systems across South Africa.
Contact Person
Precious Mnguni
Phone
+27 12 501 0300
[email protected]
Website
www.sahpra.org.za/
Address
Building A, Loftus Park, 402 Kirkness St, Arcadia, Pretoria, 0007, South Africa
Source confidence
High source confidence
Official source
eTenders.gov.za
Documents found
1
Last checked
05 Jun 2026
AI status
Enhanced
This tender has strong source evidence, including source metadata and supporting tender information synced from the government tender portal.
Tenders SA is not the issuing authority. All tenders are automatically synced from the official government tender portal. Always confirm final submission details, closing dates, briefing sessions, eligibility requirements, and documents on the official government portal before applying.
The Department of Health leads national health policy and supports provincial health systems across South Africa.
Data conflicts
None detected
Building A, Loftus Park, 402 Kirkness St, Arcadia, Pretoria, 0007, South Africa
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