GlobalCOA – Tanzania (United Republic of Tanzania) 🇹🇿
Certificate of Analysis (COA) Preparation, Review & Testing Services
Tanzanian-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services tailored to the mandatory requirements of the Tanzania Medicines and Medical Devices Authority (TMDA) and the Tanzania Bureau of Standards (TBS).
The COA is a highly critical, mandatory technical document required for both product registration and the Pre-Shipment Verification of Conformity (PVoC) process, without which goods face severe penalties or outright rejection at Customs.
🏛️ Regulatory Framework – Tanzania
Tanzania operates a comprehensive regulatory framework involving specialized agencies that strictly enforce quality requirements based on the COA.
1. Tanzania Medicines and Medical Devices Authority (TMDA)
The TMDA regulates the safety, quality, and effectiveness of Medicines, Medical Devices, Diagnostics, Food Supplements, and Cosmetics. The COA is mandatory at multiple stages:
Product Registration/Market Authorization: The COA is a core component of the registration dossier.
For Medicines, the application requires the COA for the Active Pharmaceutical Ingredient (API) and the Finished Pharmaceutical Product (FPP) (often for the batch used in stability studies).
For Sterile Medical Devices and Diagnostics, a COA is explicitly required to verify key quality parameters.
Import and Export Permit Application: An applicant requesting an import permit for pharmaceuticals must upload a Certificate of Analysis (CoA) for each product to be imported as a mandatory document. TMDA uses the COA to verify compliance before issuance of the permit and subsequent customs clearance.
Note: Food and Cosmetics registration/certification, formerly under the TMDA (formerly TFDA), has been largely transitioned to the TBS since July 2019.
Quality Surveillance: The TMDA's Quality Control Laboratory relies on the COA's specifications to test samples collected during market surveillance or import inspection.
2. Tanzania Bureau of Standards (TBS) – Pre-Shipment Verification of Conformity (PVoC)
The Tanzania Bureau of Standards (TBS) implements the mandatory Pre-Shipment Verification of Conformity (PVoC) program for most general imported goods (including food, construction materials, electronics, and general consumer items) to ensure they comply with Tanzanian standards before shipment.
Certificate of Conformity (CoC): Every consignment of PVoC-regulated products must be accompanied by a Certificate of Conformity (CoC) issued by a TBS-authorized PVoC partner (e.g., Intertek, SGS, Bureau Veritas).
Role of the COA/Test Report: The COA is the primary technical evidence reviewed during the PVoC process. Exporters must submit Conformity Documents (test reports, quality certificates, analysis reports, etc.) to the PVoC partner.
If the provided COA is satisfactory and from an accredited lab, a Documentary Check is passed. If insufficient, samples will be taken for control testing, leading to delays and costs.
Failure to obtain a CoC prior to shipment results in a penalty of 15% CIF value and mandatory destination inspection, or the consignment may be re-exported/destroyed at the exporter's cost.
Food and Cosmetics: Since 2019, TBS has taken over the primary responsibility for the registration and certification of imported food and cosmetics products, using the COA to attest to product safety and quality against Tanzanian Standards.
🔬 Our GlobalCOA Services – Tanzania
We focus on preparing COAs that satisfy the rigorous documentary verification requirements of both the TMDA (for health) and the TBS PVoC partners (for general goods).
✅ COA Preparation (Tanzanian-Compliant)
COA drafting aligned with TMDA's registration and import permit requirements.
Ensuring test parameters and acceptance criteria strictly meet the required Pharmacopeial standards (for TMDA) or Tanzanian Standards (for TBS/PVoC).
For PVoC regulated products, the COA is formatted to expedite the documentary review process by the authorized inspection agent (IAF).
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs to verify compliance with TMDA's specific format and content for API/FPP.
Verification that the COA is robust and authentic for submission to the PVoC agent to secure the CoC.
Ensuring the COA confirms a minimum remaining shelf life of six months for foodstuffs and medicines upon arrival at the port, a key import requirement.
✅ Testing & Analytical Coordination (Tanzania)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized by both TMDA and TBS/PVoC agents.
Method selection based on Pharmacopeial methods for drugs and Tanzanian Standards (TARS) / Codex Alimentarius for food and other regulated products.
📦 Product Categories Covered – Tanzania
GlobalCOA provides COA services across all regulated sectors:
🔹 TMDA Regulated: Medicines, APIs, Medical Devices, and Diagnostics.
🔹 TBS PVoC Regulated: Food and Agricultural Products, Cosmetics, Electrical/Electronic Products, Building Materials, and General Consumer Goods.
🌟 Why Choose GlobalCOA for Tanzania?
✔ Expertise in the Dual Compliance System: We meet the distinct documentary needs of both the TMDA (health) and the TBS PVoC (general imports) programs.
✔ PVoC/CoC Assurance: Our COAs are designed to pass the PVoC agent's documentary review, securing the mandatory Certificate of Conformity (CoC) and preventing customs penalties.
✔ Product Registration Support: Full COA compliance for the stringent registration dossiers for medicines and medical devices.
📝 Regulatory & Export Support – Tanzania
GlobalCOA COAs are engineered to support critical import milestones:
TMDA Product Registration Dossier (MA issuance).
TMDA Import Permit application for health products.
Obtaining the mandatory Certificate of Conformity (CoC) via the TBS PVoC program.
Customs Clearance against the submitted CoC, which is essential for TRA assessment.
Our Tanzania-focused COAs ensure efficient regulatory passage and verifiable adherence to national safety and quality standards.
📞 Get Started with GlobalCOA – Tanzania
Whether you are registering medicines or exporting consumer goods, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner for Tanzania.