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NAFDAC has intensified enforcement against counterfeit and unregistered medical products, including blacklisting a pharmaceutical company, while also issuing guidance on handling Manufacturer Investigation Reports. These actions signal a stricter regulatory environment for pharmaceutical and medical device businesses, emphasizing the need for robust compliance and due diligence. Additionally, NEPC's fish farm registration guide highlights export opportunities for aquaculture SMBs.
Pharmaceuticals
Medical Devices
Healthcare
Aquaculture/Export
Handling Manufacturer Investigation Reports for Medical Devices and IVDs
NAFDAC
NAFDAC provides guidance on the proper handling of Manufacturer Investigation Reports (MIRs) for medical devices and IVDs to ensure patient safety and regulatory compliance.
Medical device and IVD manufacturers and importers must establish robust procedures for managing MIRs, including timely reporting and corrective actions, to avoid regulatory penalties.
Blacklisting of Onifam Laboratories Ltd
NAFDAC
NAFDAC blacklisted Onifam Laboratories Ltd and associated persons/entities from pharmaceutical business activities due to regulatory misrepresentation and improper use of approvals.
Pharmaceutical companies must ensure transparency and integrity in regulatory submissions; blacklisting can result in severe business disruption and reputational damage.
Public Alert No. 037/2026 – Alert on Suspected Counterfeit Pulmicort® (Budesonide) Inhalation Suspension
NAFDAC
NAFDAC alerts the public to suspected counterfeit Pulmicort® (Budesonide) inhalation suspension in the Nigerian market, infringing on AstraZeneca's marketing authorization.
Pharmacies and distributors must verify product authenticity and source from authorized suppliers to avoid selling counterfeit products, which could lead to legal action and health risks.
Public Alert No. 036/2026 – Alert on Suspected Counterfeit Products Mimicking Forxiga® (Dapagliflozin)
NAFDAC
NAFDAC warns of suspected counterfeit Forxiga® (dapagliflozin) products in the market, infringing on AstraZeneca's marketing authorization.
Healthcare providers and patients should be vigilant; businesses must enhance supply chain security to prevent infiltration of counterfeit medicines.
Public Alert No. 035/2026 – Alert on the Marketing and Sale of Unregistered Menofix Composition
NAFDAC
NAFDAC alerts the public about the marketing and sale of unregistered Menofix Composition, raising concerns about possible health risks.
Sellers and marketers must ensure all products are registered with NAFDAC before distribution; non-compliance can lead to product seizure and legal penalties.
SON rides on e-platform to facilitate international trade
Other
SON leverages an electronic platform to streamline international trade processes, improving efficiency for exporters and importers.
Businesses involved in trade should utilize SON's e-platform to expedite certifications and reduce delays, enhancing competitiveness.
How to Register Your Fish Farm with NEPC Nigeria: A Complete Export Guide
Other
NEPC provides a guide for fish farm registration to facilitate export, outlining steps and requirements for aquaculture businesses.
Fish farmers and exporters can leverage this guide to formalize operations and access international markets, boosting revenue.
Heightened scrutiny on pharmaceutical product authenticity and registration
Increased enforcement actions against non-compliant entities
Opportunities for aquaculture exports through NEPC registration
Digitalization of trade facilitation processes by SON
1
Review and strengthen MIR handling procedures for medical device/IVD products
2
Conduct due diligence on all suppliers and products to avoid counterfeit or unregistered items
3
Ensure all pharmaceutical products are properly registered with NAFDAC before distribution
4
For fish farms, follow NEPC registration guidelines to enable export
5
Utilize SON's e-platform for trade documentation to streamline operations