Objectives

The primary objective of this tender is to procure a specialised radiopharmaceutical precursor for targeted alpha therapy at Inkosi Albert Luthuli Central Hospital. The procurement aims to secure a compliant, reliable supplier capable of delivering high-quality DOTATATE Peptide kits for laboratory labelling with Actinium-225, supporting advanced oncology treatments for patients with metastatic castration-resistant prostate cancer.

Scope

The scope covers the one-off supply and delivery of two kits of DOTATATE Peptide. Each kit contains five vials. The contract operates on a single delivery basis with a ninety-day pricing validity period. Evaluation follows a structured five-stage process encompassing administrative compliance, regulatory verification, technical specification alignment, competitive pricing, and socio-economic preference allocation. Top-scoring bidders may be required to submit physical samples for institutional testing prior to final contract award.

Technical Requirements

• Product Specifications: DOTATATE Peptide for 225Ac Labelling, supplied as a freeze-dried pharmaceutical. Strength must be 250 micrograms per vial, packaged in kits of five vials.
• Regulatory Compliance: Mandatory possession of a valid licence from the South African Health Products Regulatory Authority (SAHPRA) permitting the manufacture, import, export, wholesale, or distribution of relevant pharmaceutical/medical products.
• Quality & Shelf Life: All goods must be new, unused, and carry a minimum remaining shelf life of six months from the date of delivery. Expired or refurbished products are strictly rejected.
• Documentation: Complete submission of standard quotation forms, General and Special Conditions of Contract, Bidder Disclosure (SBD4), Preference Points Claim Form (SBD6.1), updated CIPC registration documents, B-BBEE verification certificate or sworn affidavit, and Central Supplier Database (CSD) compliance reports.
• Delivery & Logistics: All delivery costs must be included in the quoted price. Prices must remain firm throughout the contract period. Late submissions are automatically disqualified.

Skills Requirements

This tender does not mandate clinical, diagnostic, or professional healthcare skills, as it is strictly a commercial supply contract. However, bidders must demonstrate:

• Established pharmaceutical supply chain and logistics capabilities suitable for handling regulated, freeze-dried radiopharmaceutical components.
• Proven track record in public sector procurement compliance, including accurate completion of returnable documents and adherence to National Treasury supply chain management directives.
• Operational capacity to meet strict delivery deadlines and provide verifiable proof of product authenticity, regulatory licensing, and transformation status.

Explanation of Unusual or Complicated Terms

• DOTATATE Peptide for 225Ac Labelling: DOTATATE is a synthetic somatostatin analogue conjugated with a DOTA chelator. It acts as a molecular targeting vector that binds to somatostatin receptors commonly overexpressed in neuroendocrine and prostate cancers. "Labelling" refers to the chemical attachment of Actinium-225 (225Ac), a highly potent alpha-particle emitting radioactive isotope, to the peptide. The resulting compound is a targeted alpha therapy (TAT) radiopharmaceutical administered intravenously to treat advanced cancers unresponsive to conventional chemotherapy or radiotherapy.
• 80/20 Preference Point System: A South African public procurement evaluation model where eighty percent of total points are awarded based on price competitiveness, and twenty percent are allocated to designated socio-economic goals. In this tender, the full twenty points are reserved for enterprises owned by youth, verified through B-BBEE documentation or CSD records.
• SAHPRA Licensing: Regulatory clearance required by South Africa's health products authority. It ensures suppliers meet rigorous national standards for quality assurance, safety, storage conditions, and lawful distribution of pharmaceuticals and medical devices.