Namibian Healthcare Regulatory Compliance Checklist

This comprehensive checklist will help medical supply providers navigate the complex regulatory landscape in Namibia. Use it to ensure your products and operations meet all local requirements.

Ministry of Health and Social Services (MoHSS) Requirements

Product Registration

• Product classification determined (medical device, pharmaceutical, etc.)
• Complete product dossier submitted
• Certificate of pharmaceutical product (CPP) obtained (if applicable)
• Product samples submitted for testing (if required)
• Local agent/representative appointed
• Registration fees paid
• Product successfully listed in National Medicine Registry

Importer Registration

• Business registration completed
• Import license obtained
• Pharmaceutical premises licensed (if applicable)
• Good Distribution Practices (GDP) certification obtained
• Quality management system documented
• Key personnel registered with relevant authorities

Namibia Medicines Regulatory Council (NMRC) Requirements

Documentation Requirements

• Product information documents prepared in required format
• Stability data for relevant climate zones provided
• Manufacturing site certifications obtained (GMP/ISO)
• Bioequivalence studies completed (for generics)
• Packaging and labeling compliant with local requirements
• Patient information leaflets available in required languages

Ongoing Compliance

• Pharmacovigilance system established
• Periodic safety update reports schedule established
• Adverse event reporting system implemented
• Annual product quality reviews planned
• Change control procedures documented
• Recall procedures established and tested

Import Regulations

Customs Requirements

• HS codes identified for all products
• Import duties calculated and budgeted
• Customs broker appointed
• Import documentation templates prepared
• Shipping and storage requirements documented
• Temperature monitoring plan for cold chain (if applicable)

Special Categories

• Controlled substance permits obtained (if applicable)
• Hazardous materials handling procedures documented
• Special storage requirements implemented
• Transportation validation completed
• Insurance coverage adequate for product value

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This template serves as a starting point for regulatory compliance in Namibia’s healthcare sector. Requirements may change, so we recommend verifying current regulations with the appropriate authorities.