Overview:
NAFDAC is striving to attain comprehensive oversight of all products circulating within Nigeria's pharmaceutical supply chain. To realize this goal, it intends to establish and enforce regulations and guidelines. The agency anticipates that traceability will be fully operational throughout the Nigerian pharmaceutical supply chain by the conclusion of 2024.
The strategy adopted by NAFDAC (NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL) for implementing traceability aligns with the Nigeria National Traceability Strategy Policy document, which was issued by the Federal Ministry of Health in May 2020. Additionally, it corresponds with the "Africa Strategy for Pharmaceutical Traceability" initiative, endorsed by 25 African regulatory agencies and six health financing and donor organizations.
NAFDAC has formulated a five-year traceability implementation plan to enhance supply chain visibility and bolster its pharmacovigilance efforts against substandard and falsified medicines and medical devices by the end of 2024.
Key Highlights:
- Given the Nigerian context and the objectives of Nigeria's traceability implementation, a centralized model will be adopted. Under this model, event data from all entities within the supply chain will be stored in a single central repository. This repository will oversee data authentication between users and the system. All processes of event storage and retrieval will be managed by a distinct service within the central repository.
- A global standard will be used by all trading partners, from manufacturer to dispenser to identify, capture, and share information about the pharmaceutical unit as it moves in the supply chain.
- Products and locations will be globally uniquely identified
- Data will be encoded into the data carrier.
- When items and locations are uniquely identified, information about these items and locations must be shared across the supply chain to enable traceability - master data, transaction data, and event data.
TRACEABILITY OF PHARMACEUTICAL PRODUCTS REGULATIONS, Nigeria
Composition of the unique identifier:
- The unique identifier shall be constructed according to the globally accepted GS1 Specifications.
- The unique identifier shall be a sequence of numeric or alphanumeric characters that is unique to a given packaging level.
- The unique identifier of the secondary and tertiary package shall consist of the following data elements:
- Global Trade Item Number
- Batch or lot number
- Expiry date
- Serial number
- The combination of the GTIN and Serial Number shall be unique to a pharmaceutical product.
- Unique identification shall be assigned to all package label levels.
- Logistic units shall be identified with a Serial Shipping Container Code.
- A Serial Shipping Container Code may be re-used as indicated in the GS1 General Specifications.
- The relationship between the unique identifiers of the different packaging levels shall be captured in the manufacturer’s electronic internal systems.
- The data elements of the unique identifier encoded within the data carrier shall be printed on the secondary and tertiary label or package as Human Readable Interpretation (HRI) containing Global Trade Item Number, Batch or lot number, Expiry date and Serial number following the rules and recommendations of GS1 General Specifications and as may be specified by the Agency.
- The manufacturer shall share product master data with the Agency for drug and related product trade items and logistics items as may be required by the Agency.
- All supply chain stakeholders as required by these Regulations shall obtain a Global Location Number (GLN), to identify their organizations and important locations, including locations where items are manufactured and orders are received and distributed.
Data Carrier:
- The unique identifier of the secondary package shall be encoded in a GS1 Data Matrix.
- The unique identifier of the tertiary package shall be encoded in a GS1 Data Matrix, or GS1-128 Linear Barcode.
- The unique identifier of the logistics unit with a Serial Shipping Container Code shall be encoded as stated in the GS1 General Specifications.
- If the required unique identifier is only the Global Trade Item Number, the appropriate data carrier according to the GS1 General Specifications shall be used.
Data Capture and Share:
- The manufacturer or supplier shall share the data for the unique identifier of the product with the Agency before placing the pharmaceutical product on the market.
- All pharmaceutical supply chain stakeholders shall electronically capture and share with the Agency, the unique identifier with associated traceability information when they receive and distribute the product.
Data aggregation: The manufacturers shall aggregate batch numbers or serial numbers to establish a parent-child relationship between a serialized, uniquely identified parent (which effectively serves as a container), and one or more objects, that are contained.
Compliance
It is important for pharmaceutical companies to work closely with their supply chain partners and technology vendors to ensure that their serialization solutions comply with Nigerian regulations and meet the required deadlines. Non-compliance with serialization requirements can result in penalties and delays in product registration and market access.
Reference - NAFDAC – National Agency for Food & Drug Administration & Control
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 Nigeria pharmaceutical serialization requirements.
Our team of experts strategizes and plans end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences, and brand integrity.
Disclaimer
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, 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. Please use the references below to follow the updates at the source.
