GlobalCOA – Republic of Congo (Congo-Brazzaville) 🇨🇬

Certificat de Conformité (CoC) and Certificat d'Analyse (COA) Services

ACONOQ-Compliant Quality Documentation. Export-Focused.

For the Republic of Congo (ROC), the primary quality requirement is driven by a mandatory Pre-Shipment Verification of Conformity program.

🏛️ Regulatory Framework – Republic of Congo (ROC)

• Congolese Agency for Standardization and Quality (ACONOQ): ACONOQ is the authority responsible for standards and quality. It mandates the Congolese Conformity Assessment Programme (PCEC).

• PCEC & Certificate of Conformity (CoC): All regulated products imported into the Republic of Congo require a Certificate of Conformity (CoC), which is issued by an ACONOQ-authorized inspection body (e.g., Cotecna, Bureau Veritas).

• Role of the COA/Test Report: The COA is the primary technical document reviewed by the inspection body to determine if the product complies with applicable Congolese, regional, or international standards.

  • Documentary Verification: Exporters must provide Conformity Documents (Test Reports, Quality Certificates, Analysis Reports [COA], etc.). A valid COA from an ISO 17025 accredited laboratory is crucial for passing the documentary verification and avoiding mandatory physical inspection and testing.

• Direction de la Pharmacie et des Médicaments (DPM): The DPM, operating under the Ministry of Health, regulates Medicines, Medical Devices, and Health Products.

  • Market Authorization (MA): Medicine registration dossiers must be in CTD format and often in French. The COA is a mandatory technical component (Module 3 - Quality).

🔬 GlobalCOA Services – Congo-Brazzaville

• PCEC Compliance: Preparation and review of COAs that satisfy ACONOQ's PCEC requirements for the issuance of the mandatory CoC.

• DPM Dossier Support: Ensuring COAs for pharmaceuticals and health products meet the CTD requirements and are provided in the appropriate format (preferably French or English with translation).

GlobalCOA – Democratic Republic of Congo (DRC) (Congo-Kinshasa) 🇨🇩

Certificate of Inspection (BIVAC) and COA Services

OCC-Approved Quality Documentation. Import Control-Ready.

For the Democratic Republic of Congo (DRC), import control is primarily focused on pre-shipment inspection and quality verification by mandated agencies.

🏛️ Regulatory Framework – Democratic Republic of Congo (DRC)

• Congolese Control Office (OCC - Office Congolais de Contrôle): The OCC is the public institution responsible for inspection, certification, testing/analysis, and metrology of products (imports, exports, and local).

• Pre-Shipment Inspection (PSI) / BIVAC: The DRC mandates a pre-shipment inspection program for imports valued at USD 2,500 or more.

  • BIVAC Certificate: Importers must obtain a Bureau Veritas Certificate of Inspection (BIVAC Certificate) for customs clearance.

  • Role of the COA/Test Report: The COA is required by the inspection agent (Bureau Veritas/BIVAC) during the verification process to assess the quality, quantity, and value of the goods against the importer's declaration and national standards. Consignments arriving without a valid BIVAC certificate are subject to penalties.

  • OCC Levies: The OCC charges a fee (currently 1.5% of the CIF value) on imports, reflecting its responsibility for quality control and laboratory analysis. The COA provides the initial assurance needed to proceed with the BIVAC certification.

• Congolese Pharmaceutical Regulatory Authority (ACOREP): ACOREP, under the Ministry of Public Health, is the authority for regulating Medicines, Medical Devices, and Health Products.

  • Market Authorization: Medicines require registration. The quality part of the dossier requires the COA to confirm safety, efficacy, and quality standards.

  • Import Permits: ACOREP manages permit requests for importing medicines.

🔬 GlobalCOA Services – DRC

• BIVAC/PSI Compliance: Preparation and review of COAs that meet the quality verification criteria of the BIVAC/PSI process. The COA is essential for the inspection agent to issue the required Certification of Validation.

• ACOREP Dossier Support: Ensuring COAs for pharmaceuticals and health products meet the necessary quality parameters for registration and import permit applications.

• Documentation Language: Ensuring documents are available and preferably prepared in French.

📝 Combined Export Support – Congo (ROC & DRC)

Our COA services for both Congos are designed to streamline the mandatory quality verification checks required for customs clearance.

FeatureRepublic of Congo (Brazzaville) 🇨🇬Democratic Republic of Congo (Kinshasa) 🇨🇩Mandatory ProgramPCEC (Programme Congolais d'Evaluation de la Conformité)PSI/BIVAC (Pre-Shipment Inspection)Certifying BodyACONOQ-authorized partners (Cotecna, Bureau Veritas)OCC/Bureau Veritas (BIVAC)Required COA UseCrucial for Documentary Review to get the Certificate of Conformity (CoC).Essential for Value, Quantity & Quality Verification to get the BIVAC Certificate.Health AuthorityDirection de la Pharmacie et des Médicaments (DPM)Agence Congolaise de Réglementation Pharmaceutique (ACOREP)Preferred LanguageFrenchFrench

GlobalCOA ensures your Certificate of Analysis (COA) is technically sound, issued by an accredited laboratory, and formatted to expedite the mandatory conformity assessment in both countries.

📞 Get Started with GlobalCOA – Congo

Please specify whether your shipment is destined for Congo-Brazzaville (ROC) or Congo-Kinshasa (DRC) so we can provide tailored support for the specific regulatory requirements (PCEC/CoC or BIVAC).