Regulatory Guide: Importing Pharmaceuticals from Germany to Nigeria

All pharmaceutical products imported into Nigeria must be registered with the National Agency for Food and Drug Administration and Control (NAFDAC). The registration process verifies the safety, efficacy, and quality of the product.

Steps:

1. Confirm your company holds a valid Premises License from PCN and NAFDAC.
2. Obtain product dossier from the German manufacturer (CTD format preferred).
3. Submit online application via the NAFDAC Automated Product Administration and Monitoring System (NAPAMS).
4. Pay the applicable registration fees.
5. Await product evaluation (laboratory analysis, document review).
6. Respond to any queries from NAFDAC reviewers.
7. Receive NAFDAC Registration Number upon approval.

All goods entering Nigeria must clear through the Nigerian Customs Service (NCS). Pharmaceutical imports undergo additional scrutiny to prevent counterfeit medicines.

Key Steps:

1. Obtain Form M from your bank for foreign exchange allocation.
2. Arrange Pre-Arrival Assessment Report (PAAR) from NCS.
3. Submit Single Goods Declaration (SGD) electronically via NICIS II.
4. Present all shipping and product documentation at the port.
5. Undergo physical examination of goods if selected.
6. Pay applicable customs duties and Value Added Tax (VAT).
7. Obtain NAFDAC port clearance for pharmaceutical cargo.
8. Release goods upon final customs clearance.

Harmonized System (HS) codes classify pharmaceutical products for customs purposes. The correct code determines applicable duty rates and regulatory requirements.

Note: Duty rates are approximate and based on the ECOWAS CET. Always verify with the latest Nigerian Customs tariff schedule.

• NAFDAC Product Registration Certificate
• NAFDAC Import Permit
• Form M (Central Bank of Nigeria)
• Certificate of Analysis (CoA) from manufacturer
• GMP / WHO-GMP Certificate
• Commercial Invoice
• Packing List
• Bill of Lading / Airway Bill
• Certificate of Origin
• Insurance Certificate
• Phytosanitary Certificate (if applicable)
• Material Safety Data Sheet (MSDS)
• Pre-Arrival Assessment Report (PAAR)

Track your document progress in your Regulatory Checklist on the dashboard.

German pharmaceutical exporters must comply with EU and German national regulations:

• • EU GMP Compliance — Manufacturing must follow EU Good Manufacturing Practice guidelines.
• • BfArM Oversight — The Federal Institute for Drugs and Medical Devices oversees pharmaceutical product safety.
• • PEI Regulation — Paul-Ehrlich-Institut regulates vaccines and biologics.
• • EU Falsified Medicines Directive (FMD) — Serialization and tamper-evident packaging required.
• • BAFA Export Controls — Certain dual-use items require export permits from the Federal Office for Economic Affairs and Export Control.
• • WHO Pre-qualification — Many manufacturers seek WHO-GMP pre-qualification for exports to developing countries.

• • Counterfeit products — Always verify supplier certifications and request batch-level CoA.
• • Expired documents — Ensure all permits, GMP certificates, and registrations are current.
• • Incorrect HS codes — Misclassification can lead to penalties, seizure, or higher duties.
• • Cold chain breaks — Temperature-sensitive products (vaccines, biologics) require documented cold chain logistics.
• • Incomplete Form M — Failure to complete Form M correctly delays customs clearance and forex allocation.
• • NAFDAC port delays — Ensure NAFDAC clearance is pre-arranged to avoid demurrage charges.