Table of Contents
🌐 Introduction
Planning to import or distribute Ivermectin in your country? Whether you’re a pharmacy chain, hospital group, or government health buyer, registration is often required by the Ministry of Health (MOH) or national regulatory authorities.
This article outlines the standard process, documents, and tips for registering Ivermectin for sale in regulated and semi-regulated markets.
📄 Documents Required for Ivermectin Product Registration
To register Ivermectin in most countries, you’ll typically need:
- Product Dossier (CTD format) – full technical file including:
- Manufacturing process
- Quality specifications
- Clinical & stability data
- Packaging inserts/labels
- WHO-GMP or EU-GMP Certificate – issued by drug control authorities
- Certificate of Pharmaceutical Product (COPP) – in WHO format
- Free Sale Certificate (FSC) – showing legal sale in home country (India)
- Certificate of Analysis (CoA) – batch-specific test results
- Product Sample – for lab testing (often required by MOH)
- Power of Attorney (if using local agent)
🌍 Country-Specific Requirements (Examples)
Country | MOH Requirement | Notes |
Namibia | Dossier, COPP, WHO-GMP, Samples | Import permit may be issued without full registration for NGOs |
Ghana | CTD Dossier, FSC, CoA | Requires in-country lab testing |
Tanzania | Online TMDA submission + samples | New fast-track options for essential drugs |
Lebanon | COPP, Arabic labels | Local agent or distributor mandatory |
Trinidad | CARPHA approval needed | Shared regulation with Caribbean nations |
🧰 Do You Need to Register for Every Use?
Not always. Some countries allow:
- Import Permit without full registration (for institutional use)
- Special Access Scheme (SAS) or Named Patient Use
But full registration is needed for:
- Retail pharmacy sale
- Public hospital supply
- Government tenders
📦 Packaging & Labeling for Registration
- Must match submitted artwork
- Language: English / French / Arabic (as required)
- Batch No., Mfg Date, Exp Date must be printed
- Barcodes/QR codes may be required in regulated markets
🤝 Globalstar Registration Support Services
We support our B2B clients with:
✅ Product Dossier (CTD / ACTD formats)
✅ Label Design & Local Language Translation
✅ Sample Dispatch & Documentation
✅ WHO-GMP, COPP, FSC, and all MOH paperwork
✅ Dedicated export managers for Africa, LATAM, Middle East
📞 Need Ivermectin for Your Country?
Globalstar is a leading exporter of WHO-GMP certified Ivermectin tablets.
We help importers, government agencies, and private hospitals register and commercialize our products worldwide.
📩 Email: info@globalstarco.com
🌐 Website: www.globalstarco.com
Verify your Iverstar 12 product here: Check Code GS-IVM-12-2506B2