The Federal Government of Nigeria through the Ministry of Health set up the National Pharmaceutical traceability strategy to provide a universal benchmark and enforce pharmaceutical traceability in Nigeria. NAFDAC which is delegated to the regulation of distribution, sale and use of drugs, medical devices and other regulated products established a 5-year traceability implementation plan in-line with national techniques to achieve product transparency which can be tracked from manufacturer to final consumer and combat the menace of substandard medical products. The expected timeline for implementation in the Nigerian Pharmaceutical Supply Chain is end of 2024.
Nigeria has adopted the global GSI standards to identify and share information about pharmaceuticals at each point in supply chain through track and trace models with data collated in a centralised unit. Essential to this model is the availability of master, transaction and event data associated with the product at each point of the supply chain. This is to enhance coherence amongst trading partners from producers to end-users.
REQUIREMENTS TO SHARE MASTER DATA BY MARKETING AUTHORIZATION HOLDERS.
Master Data describes the unique features of a product created by its owner. Access to quality and consistent master data is key to traceability. In order to achieve the 2024 implementation date, all stakeholders and product proprietors are mandated to share legal, functional and location Master Data with the NAFDAC.
In compliance with global standards there is need for uniformity, consistency, accuracy and completeness of data so as to mitigate discrepancies in data for easy traceability in the supply chain, hence the need for this guidance document - Guidance on Master Data Attributes required for Implementation of Traceability for Pharmaceutical Products in Nigeria. This document highlights the necessary Master Data attributes required.
Brand name: a trademark used by a manufacturer to identify products distinctively from others
Functional name: the intent of the product to the consumer
Generic name: the official Active pharmaceutical ingredient
Product description: this contains the features of the product to eliminate ambiguity eg dosage strength, form and packaging.
Trade item description: same as above but for shippers to enable correct order and delivery in supply chain
Strength: the amount of active drug present
Active Ingredient: the biologically active ingredient contained in drug
Product form: accurately describes the product dispensing form like tablets, capsules, solutions etc
Route of Administration: classifies the location which the product is applied in the body
Shelf life: the length of time the product should be stored without degradation
Global Product Category Code: classifies product by grouping them based on GSI global classification
ATC code: assigned to products according to anatomical region it works
Pack size: the amount of product in a pack
Quantity: total amount contained in pack size
Unit of measurement: standard quantity of measurement of product either by law or convention eg ml,mg etc
Primary packaging material: material component that comes in direct contact with product
Packaging level: described by GTIN; a standard shipping unit of a product
Packaging type: describes material which envelopes product eg vial, blisters,caps etc
Label description: see attached link in original file
Net weight: the mass of product excluding packaging
Gross weight: the total mass of product including packaging
Directions for use: text; graphics or literature instructing product usage
NAFDAC Registration Number: number assigned to products on approval
Storage information: specified standard storage conditions
Company: legal owner of product brand
Address of Company: registered office of brand owner
Manufacturer: name of product manufacturer
Address of Manufacturer: Address of product manufacturer
GTIN for all trade item packaging levels: Unique number assigned to each packaging of a product for sale