GlobalCOA – Mozambique (Republic of Mozambique) 🇲🇿
Certificado de Análise (COA) Preparation, Review & Testing Services
Mozambican-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Mozambican regulatory requirements for products manufactured, marketed, or exported to or from Mozambique.
The COA is a core quality document essential for two distinct, mandatory import control processes: the Conformity Assessment Programme (CAP) for general goods and the Clean Report of Inspection and Analysis (CRIA) for pharmaceuticals.
🏛️ Regulatory Framework – Mozambique
Mozambique enforces a rigorous, dual-track system of quality control for imports. The COA must meet the specific needs of the product category regulator:
Instituto Nacional de Normalização e Qualidade (INNOQ) – Conformity Assessment Programme (CAP): INNOQ, the National Institute for Standardisation and Quality, oversees the mandatory Conformity Assessment Programme (CAP) for most regulated imported products (including building materials, food products, cosmetics, electrical, and general consumer goods).
Certificate of Conformity (CoC): For regulated products, a Certificate of Conformity (CoC) is mandatory for customs clearance. This CoC is issued by an INNOQ-appointed inspection agent (currently Intertek). The COA (or valid test reports) is the primary technical document used by the inspection agent to verify the product's compliance with applicable Mozambican Standards, technical regulations, or approved international standards.
Autoridade Nacional Reguladora de Medicamentos de Moçambique (ANARME) / Ministério da Saúde: The key authority responsible for regulating Pharmaceuticals, Medical Devices, and Cosmetics.
Product Registration: The registration process for medicines is rigorous, requiring a comprehensive dossier (often aligned with the CTD format). The Analytical Bulletin (i.e., the COA) of the finished product is mandatory for the Chemical and Pharmaceutical Documentation part of the dossier.
Mandatory Pre-shipment Inspection & Testing (Pharmaceuticals): For imports from certain high-risk countries (e.g., India), a mandatory Pre-shipment Inspection and Testing Program is enforced (based on Ministerial Decree 2017). This requires obtaining a Clean Report of Inspection and Analysis (CRIA) from an appointed third-party inspector for every consignment. The exporter must upload the COA for each product and all its batches in the consignment for the CRIA process.
Language Requirement: Instruction manuals and key markings on product packaging must be provided in Portuguese (the official language). This requirement often extends to key documentation like the COA for official regulatory submission.
🔬 Our GlobalCOA Services – Mozambique
We offer complete lifecycle support for Certificate of Analysis documentation, ensuring compliance with the stringent requirements of the ANARME/CRIA process and the INNOQ/CAP/CoC verification.
✅ COA Preparation (Mozambican-Compliant)
COA drafting aligned with ANARME requirements for Registration and INNOQ/CAP specifications.
Compliance with international pharmacopoeias (USP / BP / EP) for drugs and Codex Alimentarius / Mozambican Standards for food and regulated products.
CRIA Readiness: For pharmaceuticals, the COA must be detailed, batch-specific, and suitable for direct upload to the CRIA inspection agent's system.
Documentation should be prepared with Portuguese language translations to aid in regulatory review (mandatory for instructions/labeling).
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for ANARME / INNOQ / CAP compliance.
Identification and correction of non-compliance issues:
Failure to provide the COA for each batch in the consignment (a CRIA requirement).
Missing required testing parameters based on the relevant Mozambican Standard (INNOQ) for CAP products.
Discrepancies between the COA and the registered product specifications.
Verification for CoC/CRIA: Ensuring the COA/Test Report is robust, authentic, and detailed enough to satisfy the inspection bodies (Intertek/Quntrol) to issue the mandatory CoC or CRIA.
✅ Testing & Analytical Coordination (Mozambique)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally and accepted by the regulatory authorities and inspection bodies.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.
INNOQ Standards / Codex Alimentarius for food and other regulated products.
Support for the required Pre-shipment testing and verification testing conducted during the CRIA and CAP assessment processes.
📦 Product Categories Covered – Mozambique
GlobalCOA provides COA services for highly regulated sectors:
🔹 Pharmaceuticals & Health Products: APIs, Finished Drugs, and Excipients (highly regulated by ANARME via the CRIA process for imports from certain origins).
🔹 Food & Beverages: Food products and other items in Phase I of the mandatory INNOQ CAP.
🔹 Industrial & Consumer Products: Goods subject to the mandatory INNOQ Conformity Assessment Programme (CAP) (Building Materials, Electricals, Toys, etc.).
🌟 Why Choose GlobalCOA for Mozambique?
**✔ Deep expertise in the mandatory ANARME Clean Report of Inspection and Analysis (CRIA) process for pharmaceuticals.
✔ COAs aligned with mandatory INNOQ Conformity Assessment Programme (CAP) documentation for general imports.
✔ Documentation suitable for both Product Registration and the critical, mandatory Customs Clearance Certificates (CoC/CRIA).
📝 Regulatory & Export Support – Mozambique
GlobalCOA COAs support critical processes in the Mozambican context:
Product Registration Dossiers to the ANARME (as the mandatory Analytical Bulletin).
Obtaining the mandatory Certificate of Conformity (CoC) via the INNOQ CAP.
Obtaining the mandatory Clean Report of Inspection and Analysis (CRIA) for pharmaceuticals.
Customs clearance via the electronic single window (JUE), which relies on the CoC/CRIA.
Our Mozambique-focused COAs ensure compliance with both the stringent health product regulations and the broad mandate of the national standardization body.
📞 Get Started with GlobalCOA – Mozambique
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Mozambique, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.