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Technical Requirements for Pharmaceutical & Nutrition Products
Technical Requirements for Pharmaceutical & Nutrition Products
UNICEF’s 7th edition technical requirements document sets the specifications suppliers must meet to bid for the supply of pharmaceutical and nutrition products under UNICEF tenders. It applies globally to manufacturers, wholesalers, distributors and marketing license holders who can submit finished pharmaceutical products (FPPs) or nutrition products (parenteral nutrition products designed to prevent or treat nutrient deficiencies) that are registered and marketed in the country of origin. Products must comply with WHO normative standards, pharmacopoeial standards and good manufacturing practices (GMP), and must be WHO prequalified or registered by a Stringent Regulatory Authority (SRA) or WHO Listed Authority (WLA) for large biologicals. Suppliers must complete the Interagency Finished Pharmaceutical Product Questionnaire (IAFPPQ) and, where applicable, UNICEF technical questionnaires for manufacturers or wholesalers, and submit full documentation via UNICEF’s online repository. The document does not set a submission deadline; deadlines are specified in individual solicitations, LTAs or POs. For applicants, this document is a gatekeeper: only products and suppliers that meet these technical and regulatory requirements can be considered for UNICEF procurement, making compliance a prerequisite to participate in any UNICEF tender for medicines or nutrition products.
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Scope of Work
Supply of pharmaceutical and nutrition products that meet WHO normative standards and UNICEF technical requirements; manufacturers must provide full product dossiers, GMP evidence, and comply with packaging, labeling, stability and track-and-trace requirements.
Requirements & Qualifications
Suppliers must be manufacturers, wholesalers, distributors or marketing license holders; products must be registered/licensed and marketed in country of origin; Certificate of Pharmaceutical Product (CoPP/CPP) required; WHO prequalification or SRA/WLA registration for large biologicals; compliance with GMP and pharmacopoeial standards; completion of IAFPPQ and UNICEF technical questionnaires.
