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NAFDAC has intensified enforcement against counterfeit and unregistered medical products, including blacklisting a pharmaceutical company and issuing alerts on suspected counterfeits. These actions signal a stricter regulatory environment for pharmaceutical and medical device businesses, emphasizing the need for robust compliance and due diligence. Additionally, initiatives like SON's e-platform and NEPC's fish farm registration guide highlight ongoing digitalization and export facilitation efforts, which SMBs should leverage for trade efficiency.
Pharmaceuticals
Medical Devices
Healthcare
Import/Export
Food and Agriculture
Handling Manufacturer Investigation Reports for Medical Devices and IVDs
NAFDAC
NAFDAC provides guidance on handling Manufacturer Investigation Reports (MIRs) for medical devices and IVDs, emphasizing their role in assessing complaints, adverse events, and quality issues.
Medical device and IVD manufacturers and importers must ensure proper documentation and response to MIRs to maintain compliance and patient safety.
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/certificates.
Pharmaceutical companies must ensure transparent regulatory practices; blacklisting can severely disrupt business operations and supply chains.
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 to avoid penalties and protect public health; consumers should be vigilant.
Public Alert No. 036/2026 – Alert on Suspected Counterfeit Products Mimicking Forxiga® (Dapagliflozin)
NAFDAC
NAFDAC alerts the public to suspected counterfeit Forxiga® (dapagliflozin) products in Nigeria, infringing on AstraZeneca's marketing authorization.
Healthcare providers and pharmacies should source from authorized distributors and report suspicious products to NAFDAC.
Public Alert No. 035/2026 – Alert on the Marketing and Sale of Unregistered Menofix Composition
NAFDAC
NAFDAC alerts the public about the unregistered Menofix Composition being marketed and sold, raising concerns about possible regulatory violations.
Marketers and sellers must ensure all products are registered with NAFDAC before distribution to avoid legal action.
SON rides on e-platform to facilitate international trade
Other
SON is leveraging an electronic platform to facilitate international trade, streamlining processes for exporters and importers.
SMBs engaged in international trade can benefit from faster and more transparent procedures, but should stay updated on current platform features.
How to Register Your Fish Farm with NEPC Nigeria: A Complete Export Guide
Other
A guide explains how to register fish farms with NEPC for export purposes, outlining steps for compliance and market access.
Fish farmers and aquaculture SMBs can expand into export markets by following NEPC registration requirements, enhancing revenue opportunities.
Increased enforcement against counterfeit and unregistered products in the pharmaceutical sector.
Stricter scrutiny of regulatory compliance for medical devices and pharmaceuticals.
Digitalization of trade facilitation processes by agencies like SON and NEPC.
Opportunities for compliant businesses to gain market trust and avoid penalties.
Need for robust supply chain due diligence to avoid counterfeit infiltration.
1
Verify all pharmaceutical and medical device products are NAFDAC registered and sourced from authorized distributors.
2
Implement robust documentation and reporting procedures for Manufacturer Investigation Reports (MIRs).
3
Conduct regular audits of supply chains to detect and report counterfeit products.
4
Stay informed about NAFDAC public alerts and blacklists to avoid dealing with sanctioned entities.
5
Utilize SON's e-platform and NEPC registration processes to streamline trade and export activities.