Key Dates in Nigeria
May 2022 – The National Agency for Food and Drug Administration and Control (NAFDAC) has published a draft guideline on master data and enacted a consultation period to finalize it soon
End of 2024 – Full Track & Trace system is expected to be in place
The Federal Government of Nigeria through the Federal Ministry of Health, FMOH established the National Pharmaceutical Traceability Strategy to leverage global standards to establish and implement pharmaceutical traceability in Nigeria. Given the mandate of the National Agency for Food and Drug Administration and Control, NAFDAC, the burden of drug distribution, sale, use and security rests on the Agency. Hence, NAFDAC developed a 5-Year Traceability Implementation plan in line with the national strategy to achieve supply chain visibility and strengthen its pharmacovigilance activities against the scourge of Substandard and Falsified Medicines and Medical Devices. From this strategy document, it is expected that traceability becomes fully operational in the Nigerian Pharmaceutical Supply Chain by the end of the year 2024.
Companies looking to register their products with NAFDAC should follow the following steps:
- Submitting documents for registration and application letter in accordance with the issued guidelines at first instance for any of the service to be rendered by NAFDAC.
- Providing NAFDAC with the relevant information and description of the facility for inspection where it relates to registration and importation of NAFDAC regulated products.
- Providing samples of the products to be registered when notified by NAFDAC for laboratory analysis.
- Ensuring all payments are made when due
- Ensuring all documents are complete and with the appropriate description to prevent unnecessary delays.
Master Data describes attributes or characteristics of an item, entity or location that is created by the owner of that item or entity. Access to consistent, quality master data is necessary to enable traceability. To meet the 2024 implementation date, as part of regulatory compliance all stakeholders, particularly product brand owners, will be required to share legal, functional and location master data with the NAFDAC including a uniform list of attributes with their respective descriptions.
Traceability Implementation Strategy
NAFDAC aims to have full visibility over all products moving within the pharmaceutical supply chain in Nigeria and has proposed a traceability implementation strategy in line with the Nigeria National Traceability Strategy Policy document published by the Federal Ministry of Health in May 2020.
Their Traceability strategy like many other countries is based on creating an environment for:
- Providing visibility of product from plant to patient
- Promoting trust in the pharmaceutical sector and healthcare system
- Providing increased opportunity for trade of domestically manufactured pharmaceuticals
- Increasing quality of data to support pharmacovigilance
- Enabling efficiencies across the supply chain to increase patient safety
Proposed GS1 Standard
The methods of GS1 traceability are planned to be implemented and it will be mandatory for pharmaceutical suppliers, agents, and companies in Nigeria to supply pharmaceuticals with barcodes based on 2D Data Matrix and GS1 standards.
GS1 standard system includes Product Identification: GS1 identification number will make it possible to recognize products and locations by assigning unique identification globally. Capturing GS1 data carriers provide an array of choices for package types and products which help them with efficient sharing of information from trusted and authentic sources with GS1 standards implementation.
How Can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the Nigerian pharmaceutical serialization requirements as and when the regulations evolve.
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This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, partners and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions.
Source - NAFDAC – National Agency for Food & Drug Administration & Control