GlobalCOA – Libya (State of Libya) πŸ‡±πŸ‡Ύ

Certificate of Analysis (COA) Preparation, Review & Testing Services

Libyan-Compliant COAs. Regulatory-Ready. Export-Focused.

GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Libyan regulatory requirements for products manufactured, marketed, or exported to or from Libya.

The COA is a primary document required for both product registration (for health products/food) and the mandatory Certificate of Inspection (CoI) program for financed imports.

πŸ›οΈ Regulatory Framework – Libya

Libya's regulatory environment, while historically complex due to organizational restructuring, has two critical, mandatory documentation requirements for imports that rely heavily on the COA:

  • Mandatory Certificate of Inspection (CoI) for L/C Financing: Following Central Bank of Libya (CBL) Resolution NΒ° 96 of 2015, all goods imported under a Letter of Credit (L/C) financing must be accompanied by a Certificate of Inspection (CoI) (sometimes referred to as a Certificate of Conformity or CoC). This certificate is issued by an approved international inspection company and requires documentary verification, physical inspection, and lab testing (if necessary). The COA is the primary document used to confirm the quality and compliance of the goods against the agreed standards.

  • General Authority for Food and Drugs (GAFD) / Food and Drug Control Center (FDCC): The key body responsible for the oversight of Food Safety and Pharmaceutical Products (including licensing, inspection, and quality control). The GAFD sets food safety standards and inspects food products, while the FDCC performs the enforcement and verification.

  • Libyan National Centre for Standardization and Metrology (LNCSM): The national body responsible for developing and implementing Libyan National Standards. The LNCSM's standards (or adopted international/Codex standards in their absence) form the basis for the conformity assessment required for the CoI.

  • Traceability and Digital System:

    • Advanced Cargo Information (ACI) System: Since late 2024, Libya requires Advance Cargo Information through the ACI system (via the Nafeza platform), which requires the electronic submission of all shipment documents.

    • Pharmaceutical Serialization: Libya mandates GS1 DataMatrix serialization for pharmaceuticals and medical devices, requiring the GTIN, Serial Number, Batch/Lot number, and Expiry date on the packagingβ€”data points that must align with the COA.

  • International Standards: Libya recognizes international standards, especially for food and pharmaceuticals:

    • Codex Alimentarius: Generally accepted for food safety standards where a Libyan standard does not exist. Halal standards (often referencing SMIIC) are mandatory.

    • BP / USP / EP / Ph. Int.: Referenced for pharmaceutical quality, though the local registration process is often hindered by technical capacity.

πŸ”¬ Our GlobalCOA Services – Libya

We focus on preparing COAs that meet the dual, mandatory requirements of the CBL/CoI process and the GAFD/FDCC quality verification.

βœ… COA Preparation (Libyan-Compliant)

  • COA drafting aligned with GAFD/FDCC requirements for product compliance and mandatory LNCSM/CoI standards.

  • Compliance with international pharmacopoeias (USP / BP / EP) for drugs and Codex/LNCSM standards for food and general products.

  • COA must include specific details, including the Batch/Lot number and Expiry Date, to satisfy traceability (serialization and ACI) requirements.

  • Labeling requirements, which mandate Arabic labeling for key information (name, net weight, ingredients, dates), must be supported by the COA's details.

βœ… COA Review & Regulatory Compliance Assessment

  • Review of existing COAs for CBL CoI / GAFD / LNCSM compliance.

  • Identification and correction of non-compliance issues:

    • Missing mandatory testing parameters (e.g., confirmation of Halal compliance, absence of prohibited additives like potassium bromate).

    • Incorrect acceptance criteria or non-approved test methods, potentially leading to rejection during the CoI documentary verification.

  • Verification for CoI: Ensuring the COA is robust and authentic for submission to the authorized Inspection Bodies for the mandatory Certificate of Inspection (CoI).

βœ… Testing & Analytical Coordination (Libya)

  • Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally and acceptable to the inspection bodies issuing the CoI.

  • Method selection as per:

    • Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.

    • LNCSM Standards / Codex Alimentarius for food and other regulated products.

    • Validated in-house methods with appropriate documentation.

  • Support for the required Laboratory Testing when sampling is mandated by the CoI inspection agent.

πŸ“¦ Product Categories Covered – Libya

GlobalCOA provides COA services for highly regulated sectors:

  • πŸ”Ή Pharmaceuticals & Health Products: APIs, Finished Drugs, and Excipients (regulated by GAFD/FDCC).

  • πŸ”Ή Food & Beverages: All Food Products, Ingredients, and Feed (regulated by GAFD/FDCC).

  • πŸ”Ή General Imports: Goods subject to the mandatory CBL Certificate of Inspection (CoI) requirement for L/C financing.

🏭 Industries We Serve – Libya

GlobalCOA supports regulated industries targeting the Libyan market, including:

  • Pharmaceuticals & APIs Suppliers

  • Food & Beverage Exporters/Manufacturers

  • Trading and Export-Import businesses

🌟 Why Choose GlobalCOA for Libya?

  • **βœ” Deep understanding of the CBL Resolution NΒ° 96 and the mandatory Certificate of Inspection (CoI) process.

  • βœ” COAs aligned with LNCSM standards and the digital/serialization requirements of the ACI system.

  • βœ” Documentation suitable for both CBL L/C opening and GAFD/FDCC port clearance.

πŸ“ Regulatory & Export Support – Libya

GlobalCOA COAs support critical processes in the Libyan context:

  • Obtaining the mandatory Certificate of Inspection (CoI) from authorized inspection bodies.

  • Electronic submission of quality documents into the ACI/Nafeza customs system.

  • Customs clearance and quality verification by the FDCC/GAFD at ports of entry.

  • Supporting documentation for compliance with Halal and local labeling rules.

Our Libya-focused COAs ensure efficient regulatory passage for financed imports and compliance with strict quality mandates.

πŸ“ž Get Started with GlobalCOA – Libya

Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Libya, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.