Supply and delivery of medical diagnostic agents and contrast media for the south african department of health (2027-2030)

Bidder must provide the following in PBD4.1: registered legal name (as on CSD), CSD number, vendor number, SBD1 form, postal address for contract enquiries, contract enquiries contact (title, surname, name, email, office telephone, cell number), orders enquiries contact (name, surname, email, telephone), and National Key Account Manager or Tender Manager (name, surname, email, office telephone, cell number).

Submit all returnable documents as specified in the tender. Complete PBD4.1 (Bidder Contact Details) in full, including: registered legal name (as per CSD), CSD number, vendor number, SBD1 form, and all required contact details for contract enquiries, orders, and tender management. Ensure accuracy to avoid disqualification.

Evaluation includes verification of: registration on the Central Supplier Database (CSD) with a valid CSD number; possession of a vendor number; legal entity registration (name must match CSD records); and provision of verifiable contact details for contract, orders, and tender management.

Returnable Documents: Bidders must mark with an X in the relevant cell to indicate the type of single bidding enterprise. Options include: Close Corporation, Company, Incorporated Joint Venture, or Listed Company.

Eligibility: Bidders must be legally registered entities (e.g., Close Corporation, Company, Incorporated Joint Venture, Listed Company). Director details required: full names, surname, nationality, ID/passport number (for foreigners), and declaration of executive/non-executive status. Conflicts of interest: Must declare if any director has ownership or directorship in related enterprises bidding for this tender.

Supply and delivery of diagnostic agents and contrast media to the Department of Health for the period 01 July 2027 to 30 June 2030. Items include: contrast media (barium sulfate suspensions/powders, iohexol injections, gadobutrol, gadopentetic acid, meglumine/amidotrizoate solutions), diagnostic strips (fluorescein sodium, LAM antigen, urine test strips for 10 parameters), and tuberculin PPD test kits. All items must meet specified volumes, concentrations, packaging, and performance requirements (e.g., ascorbic acid resistance, result timeframes).

Submit a completed bid response form with all required fields, including: item specifications, delivered prices in ZAR (two decimal places, not exceeding SEP), product registration details, manufacturer/distributor information, conformance declarations (Y/N with deviation details if applicable), barcode details (EAN 13, ITF14, 2D), API source information, and local content percentages. Ensure all returnable documents are included.

Evaluation is based on: legal status (registered entity with valid CSD number), compliance (products must be SA-approved/registered, manufacturers must hold valid licenses covering the tender period, ability to meet estimated quantities), technical capacity (demonstrated ability to supply within lead times of ≤14 days or ≤75 days for initial delivery, sufficient monthly batch capacity, compliance with packaging/barcoding standards), and financial capacity (competitive pricing within SEP limits).

Supply and deliver diagnostic agents and contrast media as per the following specifications: Barium sulfate 4.6% m/m suspension for CT scan examinations (225ml), Barium sulfate 96% powder for suspension for rectal use (prefilled enema kit with disposable tubing and tip, 397g), Barium sulfate 98% m/m powder for oral suspension (340g), Fluorescein sodium impregnated strips (sterile, dry, 1mg, 100's per pack), Fluorescein 100mg/ml injection (5ml), Gadobutrol 604.72mg/ml injection, Gadopentetic Acid 469.01mg/ml injection (20ml), LAM antigen urine test strips (25's with pipettes), Meglumine amidotrizoate/sodium amidotrizoate solutions (66g/10g per 100ml, 260mg/40mg per 250ml, 520mg/80mg per 20ml), Iohexol injections (300mg iodine/ml in 50ml and 100ml, 350mg iodine/ml in 50ml and 100ml), Tuberculin PPD liquid test (2tu/0.1ml, 1.5ml vial kit for intradermal Mantoux testing), and urine test strips for 10 parameters (glucose, protein, pH, nitrite, ketone, urobilinogen, bilirubin, blood, leukocytes, specific gravity; 100 strips per container, long handle, ascorbic acid-resistant, results in ≤3 minutes, interpretation guide on container).

Pricing must be in ZAR with two decimal places. Delivered price per unit and per shipper pack must not exceed the SEP (current listing). Provide a breakdown of the delivered price attributable to API, formulation, packaging, logistics, and gross margin. Specify percentages for local vs. imported content in each category. If pricing is in a currency other than ZAR, declare the currency used.

Bidders must provide: registered legal name, Central Supplier Database (CSD) number, product registration numbers, license to manufacture medicines (number and expiry date), and NAPPI codes. All products must conform to specifications (declare Y/N and detail deviations if any). Lead-time must not exceed 14 calendar days (or 75 days for initial delivery). Specify minimum order quantities, batch sizes, and monthly batch capacity for the contract duration. Declare local content percentages for API, raw materials, formulation, packaging, and logistics. If manufacturers or distributors are third parties, complete PBD1 form.

Closing date for submissions: 03 August 2026 at 11:00 SAST.

Supplier must provide:

• Queries contact: Telephone number and email for public sector queries (including returns).
• Debtors contact: Telephone number and email for the public sector debtors department.
• Physical and postal addresses as per the contract.

Note: No government-side contacts are specified in the document.

Returnable Documents: All invoices must include the following as per Annexure B:

• Invoice header: Must be one of: TAX INVOICE (original), COPY TAX INVOICE (supplier copy), or COPY TAX INVOICE (customer/facility copy).
• Supplier information: Logo, name (as per contract), NDoH Supplier Code, CSD registration number (MAAA), company registration number, VAT number, and authorised distributor name.
• Supplier contact details: Physical and postal addresses, queries contact number and email, debtors contact number and email.
• Deliver To information: Account number, facility name, demander code, MHFL code, delivery address, name/rank of delegated receiver, and facility phone number.
• Invoice details: Unique invoice number, invoice number barcode, invoice date, and page numbering (e.g., 'Page 1 of 3').
• Order details: Purchase Order number (one per invoice), PO barcode, order captured date, and special instructions (e.g., emergency orders).
• Invoice line items: Item barcode (EAN 13), generic product description, brand name, contract/addendum/item number (e.g., HP13-2013ARV_04_001), quantity ordered, quantity supplied, batch number (separate line per batch), expiry date (separate line per expiry), unit price (VAT incl., 4 decimal points), and total line price.
• Summary: Total Ex VAT (2 decimal points), VAT amount (2 decimal points), and total sum of Ex VAT + VAT (2 decimal points).
• Invoice To information: Pay office name, address, VAT number, and phone number.
• Goods Received By (Proof of Delivery): Date received, printed name, PERSAL number, signature, number of cartons received, facility stamp space, GRV number space, and claim reference number (if applicable).

All invoices must include the following minimum data as per Annexure B:

• Invoice header: TAX INVOICE (original), COPY TAX INVOICE (supplier), or COPY TAX INVOICE (customer).
• Supplier details: Logo, name, NDoH Supplier Code, CSD registration (MAAA), company registration, VAT number, and distributor name.
• Contact details: Physical/postal addresses, queries contact (phone/email), debtors contact (phone/email).
• Deliver To: Account number, facility name, demander code, MHFL code, delivery address, receiver name/rank, facility phone.
• Invoice details: Unique number, barcode, date, page count.
• Order details: PO number, PO barcode, order captured date, special instructions.
• Line items: Item barcode, generic/brand name, contract/addendum/item number, quantities ordered/supplied, batch number, expiry date, unit price (VAT incl.), line total.
• Summary: Total Ex VAT, VAT amount, total sum (Ex VAT + VAT).
• Invoice To: Pay office name, address, VAT number, phone.
• Proof of Delivery: Date, receiver name, PERSAL number, signature, cartons received, facility stamp, GRV number, claim reference.

Evaluation will consider:

• General Compliance:
• Valid NDoH Supplier Code and registration with the National Department of Health.
• Valid CSD registration number (MAAA).
• Legal company registration with valid Company Registration Number and VAT number.
• Authorised distributor details (if applicable).
• Technical Capability:
• Ability to generate compliant barcodes (EAN 13, 1D).
• Capacity to meet delivery timelines and Purchase Order specifications.
• Systems to track batch numbers and expiry dates per product.
• Financial Stability:
• Stable financial standing to handle public sector debtors and queries.
• Compliance with VAT and tax invoicing standards.

Supply and delivery of diagnostic agents and contrast media must comply with:

• Product specifications: Generic description, brand name, and contract/addendum/item number (e.g., HP13-2013ARV_04_001) as per Contract Circular and Purchase Order.
• Batch and expiry tracking: Each batch number and expiry date must appear on a separate invoice line with the corresponding quantity.
• Barcoding: Item barcode (EAN 13) and Purchase Order barcode (1D) must be included on invoices.
• Pricing: Unit price must include VAT and delivery, formatted to 4 decimal points.
• Delivery: Products must be delivered to the specified facility address with Proof of Delivery documentation.

Invoicing requirements:

• Pricing must include VAT and delivery costs, with unit prices to 4 decimal points.
• Invoices must break down: Total Ex VAT (2 decimal points), VAT amount (2 decimal points), and total sum (Ex VAT + VAT, 2 decimal points).
• Each invoice must reference a single Purchase Order number.
• Payment terms and guarantees are not specified in the provided document.

Mandatory compliance:

• CSD registration: Supplier must provide a valid CSD registration number (MAAA).
• Company registration: Supplier must provide company registration number and VAT number as per contract.
• NDoH Supplier Code: Must be included as per the contract circular.
• Proof of Delivery: Invoices must include Goods Received By information (date, name, PERSAL number, signature, cartons received, facility stamp, GRV number).

Supplier must provide contact details for:

• Public sector queries (including returns): Telephone number and email.
• Debtors department: Telephone number and email.
• Physical and postal addresses as per the contract.

Note: No government-side contacts are specified in the document.

The tender requires the supply and delivery of diagnostic agents and contrast media to the Department of Health for the period 01 July 2027 to 30 June 2030. Bidders must ensure all products meet regulatory standards, including valid SAHPRA-approved Medicine Registration Certificates (MRC) and compliance with Good Manufacturing Practice (GMP).

Submit all bid documents in the exact order listed in the tender. Mandatory documents must be included; if a document is not applicable, mark it as 'N/A' with justification. Failure to submit mandatory documents will disqualify the bid. Required mandatory documents: Covering Letter, PBD3 (Bid Signature Authorisation, original or certified copy), SBD1 (Invitation to bid), CSD Registration report, SARS Tax Clearance Pin, CIPC registration certificate, SBD4 (Declaration of interest), SBD6.1 (Preference Points Claimed), Valid B-BBEE Certificate (SANAS-accredited) or Sworn Affidavit for EME/QSE, PBD11 (Declaration of Financial Solvency and Business Rescue Status), PBD5 (GMP Compliance Declaration), SBD5 (National Industrial Participation Programme), Valid licences to manufacture/import (LICMI, LICM, LICCM, LICMD) with certified copies and annexures, MRC (Medicine Registration Certificates) with annexures, PBD8 (SRCC and GCC Compliance Declaration), SRCC and GCC copies (initial every page), and Signed Excel Bid Response (Pricing Schedule). Note: Unsigned Pricing Schedule will result in disqualification. Administrative documents: Bid/File Index, PBD4.1 (Contact Details of Bidder), CIPC notice of change in Directors, Proof of company changes (mergers, acquisitions, name changes), PBD9.1/9.2 (Entity Directors for single/multi-entity bids), Identification documents of Directors (certified copies), PBD1 (Third Party Authorisation Declaration), PBD1.1 (List of third-party products), PBD1.2 (Third-party undertaking), Package Inserts (original, with QR codes), Proof of sample submission, Bidder’s item list, and USB with digital copies (files named using index admin codes). All documents must be sorted, filed, and submitted in the exact order specified.

Evaluation will assess the following: Legal: Valid CIPC registration, SARS Tax Clearance Pin, and compliance with B-BBEE requirements (SANAS-accredited certificates where applicable). No business rescue status (PBD11). Technical: Valid licences to manufacture/import (LICMI, LICM, LICCM, LICMD), SAHPRA-registered products (MRC) with up-to-date annexures, and GMP compliance (PBD5). Financial: Declaration of financial solvency (PBD11) and signed pricing schedule. Operational: Ability to supply diagnostic agents and contrast media as per specifications, and compliance with the National Industrial Participation Programme (SBD5).

All products must comply with regulatory requirements, including: Valid Medicine Registration Certificates (MRC) issued by SAHPRA, with all annexures. Products must have approved Package Inserts (PI) with QR codes for professional information. Proof of sample submission may be required. Bidders must provide a list of products offered (Bidder’s item list). Products must meet Good Manufacturing Practice (GMP) standards. Valid licences to manufacture/import (LICMI, LICM, LICCM, LICMD) are mandatory, with preference for locally produced products.

Submit a signed Excel Bid Response (Pricing Schedule). Failure to sign the pricing schedule will result in disqualification. Declaration of financial solvency (PBD11) is mandatory.

Mandatory compliance documents: Valid CSD Registration report, SARS Tax Clearance Pin, CIPC registration certificate, Valid B-BBEE Certificate (SANAS-accredited) or Sworn Affidavit for EME/QSE, Declaration of Financial Solvency and Business Rescue Status (PBD11), GMP Compliance Declaration (PBD5), National Industrial Participation Programme (SBD5), Valid licences to manufacture/import (LICMI, LICM, LICCM, LICMD) with certified copies and annexures, MRC and MRC Annexures (SAHPRA), Variation Summary (VARSUM) for MRC changes (certified copies), SRCC and GCC Compliance Declaration (PBD8).

Preference points for specific goals are allocated under the Preferential Procurement Regulations, 2022. Bidders must meet the following B-BBEE criteria to qualify for preference points: QSEs (turnover R10M–R50M) and EMEs (turnover < R10M) must submit a correctly completed sworn affidavit. Large enterprises (turnover > R50M) must submit a valid SANAS-accredited B-BBEE certificate. Incorrectly completed QSE/EME sworn affidavits are deemed invalid, and no preference points will be awarded.

B-BBEE Compliance: Bidders must classify as either a Qualifying Small Enterprise (QSE) or Exempted Micro Enterprise (EME) to submit a sworn affidavit. QSE: Annual turnover between R10,000,000 and R50,000,000. EME: Annual turnover less than R10,000,000. Bidders with turnover exceeding R50,000,000 must submit a valid SANAS-accredited B-BBEE certificate and cannot use the EME/QSE affidavit. Sworn Affidavit Requirements: 1. Deponent’s full name and ID number as per identity document. 2. Designation (director, owner, or member) must be clearly indicated and underlined/circled. 3. Enterprise name (as per CIPC registration) and business address. 4. Percentage of black ownership, black female ownership, and designated group ownership. 5. Total revenue for the year under review, specifying if based on audited financial statements or management accounts. 6. Financial year-end as per enterprise registration documents. 7. B-BBEE Status Level of Contributor (only one level permitted). 8. Empowering supplier status (QSEs must specify the basis). 9. Deponent and Commissioner of Oaths’ signature dates must match. 10. Commissioner of Oaths cannot be an employee or ex-officio of the enterprise.

Preference points for specific goals are allocated under the Preferential Procurement Regulations, 2022. Incorrectly completed QSE/EME sworn affidavits are deemed invalid, and no preference points will be awarded.

Closing date: 03 August 2026 at 11:00. Non-compulsory online briefing session: 19 June 2026 at 10:00 via MS Teams. Bid validity period: 180 days.

Queries: Email [email protected]. Submission address: Dr AB Xuma Building, 1112 Voortrekker Road, Block A, Pretoria Townlands 351-JR, Pretoria, 0187. Pharmaceutical Tender Box in the reception area. For NIP Programme queries: Contact Ms R Muthan at (012) 394 1288, Mobile (066) 301 2051, or email [email protected].

Submit bids using the official forms provided (do not re-type). Deliver bids by the closing date and time (03 August 2026, 11:00) to: The Director-General: Health, Directorate: Affordable Medicines, Dr AB Xuma Building, 1112 Voortrekker Road, Block A, Pretoria Townlands 351-JR, Pretoria, 0187. Deposit bids in the Pharmaceutical Tender Box in the reception area. Late bids will not be accepted. Ensure bids are addressed and delivered to the correct location. Include all required documents as per the Bid Document Checklist (Paragraph 3) and Bid Documents (Paragraphs 4.1.1 to 4.1.7). Consortiums, joint ventures, and partnerships must comply with Paragraph 4.3. Submission requirements are detailed in Paragraphs 9 and 10.

Evaluation follows the 90/10 Preferential Procurement Regulations, 2022. 90 points are allocated for price (lowest price scores highest). 10 points are allocated for B-BBEE Status Level of Contributor. Points for B-BBEE are awarded as follows: Level 1 (10), Level 2 (9), Level 3 (8), Level 4 (6), Level 5 (5), Level 6 (4), Level 7 (3), Level 8 (2), Non-compliant (0). Valid SANAS-accredited B-BBEE certificates or sworn affidavits (for EMEs/QSEs) are required to claim points. Failure to submit proof results in zero preference points. Bids are open to all natural/juristic persons (local or foreign), but bidders must not be in the service of the state or have directors/members in state service. Bidders must declare compliance with Good Manufacturing Practice (GMP) and financial solvency.

Bid validity period: 180 days. Pricing must be submitted as per the official bid forms. Successful bidders with contracts exceeding R10 million must comply with the National Industrial Participation (NIP) Programme. This includes submitting a performance guarantee to the DTI, a business concept for approval, detailed business plans, and bi-annual progress reports. NIP obligations apply if imported content meets or exceeds US$10 million (or equivalent) under specific conditions. For contracts with imported content, submit details to the DTI within 5 working days of award.

Tax Compliance: Submit a Tax Compliance Status (TCS) PIN (via SARS e-filing) or a CSD registration number. Each party in a consortium/joint venture must submit separate TCS/CSD documentation. VAT registration details are required. B-BBEE: Submit a valid SANAS-accredited B-BBEE certificate or sworn affidavit (for EMEs/QSEs). Bidders must not be listed on the Register for Tender Defaulters or the List of Restricted Suppliers. Bidders must declare if they or their directors are employed by the state via SBD4. Foreign suppliers must complete the Questionnaire for Bidding Foreign Suppliers. Bidders must confirm financial solvency and absence of business rescue/liquidation via PBD11. Non-compliance with declarations or false information may result in disqualification, contract termination, reporting to National Treasury, or legal action.

Contract duration: 01 July 2027 to 30 June 2030. Successful bidders must sign a written contract (SBD7). Contracts exceeding R10 million must comply with the National Industrial Participation (NIP) Programme, including submitting a performance guarantee, business concept, and detailed plans to the DTI. Non-compliance with financial solvency declarations or false information may result in disqualification, contract termination, reporting to National Treasury, or legal action. Bidders must notify the Department within 5 working days of any material financial changes during the bid validity or contract term.

Evaluation is based on the 90/10 Preferential Procurement Regulations, 2022. 90 points are allocated for price (lowest price scores highest). 10 points are allocated for B-BBEE Status Level of Contributor, with higher levels receiving more points. Points are awarded as follows: Level 1 (10), Level 2 (9), Level 3 (8), Level 4 (6), Level 5 (5), Level 6 (4), Level 7 (3), Level 8 (2), Non-compliant (0). Valid B-BBEE certificates or sworn affidavits (for EMEs/QSEs) are required to claim points.

Bidders must categorise their multi-entity bidding enterprise as one of: Partnership, Joint Venture Unincorporated, Consortium, or Listed Company. Full details of all directors for each entity must be provided, including names, roles, and other directorships.

Submit the completed PBD9.2 form. Required details: all directors for each entity in the bidding enterprise must be listed with full transparency.

General: Must be a registered multi-entity bidding enterprise. All entities must have valid CSD registration (MAAA number). Must be able to supply diagnostic agents and contrast media as per the Department of Health's specifications. Directors: All directors must be disclosed with full names, surname, entity affiliation (A, B, or C), nationality, ID or passport number (for foreigners), appointment status (Y/N), executive/non-executive role, and any other directorships or ownership in other enterprises. Enterprise Type: Must categorise as one of: Partnership, Joint Venture Unincorporated, Consortium, or Listed Company.

Provide full details of all directors for each entity in the bidding enterprise, including: full names, surname, entity affiliation (A, B, or C), nationality, ID or passport number (for foreigners), director appointment status (Y/N), executive/non-executive role, and any other directorships or ownership in other enterprises.

CSD registration (MAAA number) required for each entity in the bidding enterprise. Enterprise must be categorised as one of: Partnership, Joint Venture Unincorporated, Consortium, or Listed Company.