GlobalCOA – Tunisia (Republic of Tunisia) 🇹🇳
Certificat d'Analyse (COA) Preparation, Review & Testing Services
Tunisian-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services tailored to the specific technical control procedures required by Tunisian authorities for imported goods.
The COA is a highly critical, mandatory technical document required for both product registration (especially health products) and the technical control procedure at the border, without which goods cannot obtain clearance.
🏛️ Regulatory Framework – Tunisia
Tunisia maintains a strict technical control procedure for imports, enforced by various technical departments before final customs clearance, focusing heavily on quality, safety, and conformity with national standards.
1. Direction de la Pharmacie et du Médicament (DPM) / Ministry of Health
The DPM is the main authority regulating Medicinal Products, Medical Devices, and limited-sale cosmetics. The COA is mandatory at multiple stages:
Product Registration/Market Authorization (MA): All medicines must be registered. The dossier is submitted to the DPM and follows international best practices.
The DPM's National Laboratory of Medicinal Products Control (LNCM) is in charge of the chemical and pharmaceutical assessment (Quality) of the dossier. The COA provides the necessary specifications for this assessment.
Specific Products: All medical devices require Marketing Authorization (AMC - Autorisation de Mise à la Consommation) issued by the DPM.
Technical Control on Import: The DPM coordinates the technical control at the border for medicines, medical accessories, and limited-sale cosmetics. The COA is required to support the quality claims of the imported product.
2. Technical Control Departments (Ministry of Commerce)
For a wide range of consumer and food products, the Technical Control Procedure on Import is mandatory before customs clearance. The COA forms a core part of the Technical File submitted via the TTN (Tunisian TradeNet) platform.
Key Clearance Documents: The importer must submit a file to the relevant technical control department before the goods arrive, which includes the Purchase Invoice, Certificate of Origin, Packing List, and the Technical File.
The Technical File: Must include the Technical Sheet (fixing product composition, safety rules, etc.) and, crucially, the Certificate of Analysis or equivalent for quality verification.
Product Classification: The Department of Commerce classifies products for technical inspection into categories (A, B, C).
Authorization for Consumption (AMC) or Conditional Authorization (APE):
The Technical Department studies the file and may grant an AMC (Autorisation de Mise à la Consommation) based on the documentation (including the COA).
If the file is incomplete or suspect, a conditional APE (Autorisation Provisoire d'Enlèvement) may be granted, followed by an inspection, sampling, and laboratory analysis at the importer's depot to verify the COA's claims.
Special Certificates for Food/Agriculture: Products of animal or plant origin must be accompanied by a Health, Sanitary, or Phytosanitary Certificate and a Certificate of Non-Radioactive Contamination issued by the competent authorities in the country of origin. These are specialized forms of COA.
3. National Institute for Standardization and Industrial Property (INNORPI)
INNORPI is responsible for establishing national standards (Tunisian Standards - NT) and managing certification activities. The COA provides the technical evidence to demonstrate conformity to these national standards, a key part of the technical control process.
Language Requirement: Documentation, including the COA, is required or strongly preferred in French or Arabic to ensure efficient regulatory processing.
🔬 Our GlobalCOA Services – Tunisia
We specialize in preparing COAs that meet the documentary requirements for the Authorization for Consumption (AMC) process and the stringent needs of the DPM.
✅ COA Preparation (Tunisian-Compliant)
COA drafting aligned with DPM registration requirements and the specific data required for the Technical Control Procedure on imports.
Compliance with international pharmacopoeias for drugs and Codex Alimentarius / Tunisian Standards (NT) for food and general products.
Ensuring specific attestations, such as non-contamination by radioactivity and dioxin (particularly for food/feed and animal products), are covered by supporting test reports where required by the Technical Control Department.
Documentation prepared in French, Arabic, or English (submission in French or Arabic is highly preferred).
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs to verify compliance with the Technical File requirements for the AMC application.
Identification and correction of non-compliance issues (e.g., missing compositional data in the technical sheet, or insufficient coverage of mandatory safety parameters).
Verification for AMC: Ensuring the COA is robust and authentic to secure the Authorization for Consumption (AMC) and prevent mandatory port inspection and sampling.
✅ Testing & Analytical Coordination (Tunisia)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized by the Tunisian Accreditation Council (TUNAC) and accepted by the Technical Control Departments.
Method selection based on Pharmacopeial methods for drugs and Tunisian Standards (NT) / Codex Alimentarius for other regulated products.
📦 Product Categories Covered – Tunisia
GlobalCOA provides COA services for regulated sectors:
🔹 DPM Regulated: Pharmaceuticals, Medical Devices, and limited-sale cosmetics.
🔹 Technical Control/AMC Regulated: Food, Food Supplements, Animal and Plant Products (requiring Sanitary/Phytosanitary COAs), and a wide range of consumer goods (electronics, building materials, textiles, etc.).
🌟 Why Choose GlobalCOA for Tunisia?
**✔ Deep understanding of the Technical Control Procedure and the requirements for Authorization for Consumption (AMC).
✔ Expertise in preparing COAs that include the mandatory attestations for non-contamination (radioactivity/dioxin) for sensitive products.
✔ Documentation suitable for both Product Registration (DPM) and the critical Customs Clearance process.
📝 Regulatory & Export Support – Tunisia
GlobalCOA COAs support critical processes in the Tunisian context:
Product Registration Dossiers to the DPM (MA issuance).
Obtaining the Authorization for Consumption (AMC) for all controlled imports.
Customs clearance and verification by the Technical Control Departments.
Our Tunisia-focused COAs ensure products meet national quality benchmarks, minimizing the risk of delays, conditional clearance (APE), or destruction/rejection at the border.
📞 Get Started with GlobalCOA – Tunisia
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Tunisia, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.