How to Get Product Registration & EXIM Code in Nepal 2025

Product registration and import-export authorization represent critical requirements for businesses operating in Nepal’s regulated markets. Every product entering Nepal’s market must comply with specific registration requirements, while international trade requires proper EXIM code authorization.

Understanding Nepal’s Product Registration Framework

Product registration in Nepal operates through multiple specialized agencies, each governing specific product categories. Institutions charged with establishing standards include the Nepal Bureau of Standards and Metrology and the Department of Drug Administration, ensuring product safety and quality compliance.

Key Regulatory Authorities

Authority	Product Categories	Primary Functions
Department of Drug Administration (DDA)	Pharmaceuticals, Medical Devices	Drug registration, quality control, market surveillance
Department of Food Technology and Quality Control	Food Products, Beverages	Food safety standards, quality certification
Nepal Bureau of Standards and Metrology	Industrial Products, Consumer Goods	Standards development, conformity assessment
Department of Customs	Import/Export Goods	EXIM code issuance, trade facilitation
Ministry of Agriculture and Livestock Development	Agricultural Products, Seeds	Product approval, quality standards

EXIM Code Registration Process

Export Import (ExIm) code is registration required for the person importing or exporting goods from Nepal. ExIm code is issued by the Department of Customs, Ministry of Finance Government of Nepal.

EXIM Code Requirements and Eligibility

A company registered in Nepal with a minimum Paid up Capital up to 10 Lakh can apply for an EXIM Code, however for export purpose solely; no minimum Paid up Capital is required.

Capital Requirements for EXIM Code

Business Purpose	Minimum Paid-up Capital	Additional Requirements
Import Operations	NPR 10,00,000	Bank guarantee required
Export Operations	No minimum requirement	Company registration certificate
Import-Export Combined	NPR 10,00,000	Annual renewal with bank guarantee

Step-by-Step EXIM Code Registration

Phase 1: Pre-Registration Preparation

Before initiating EXIM code registration, businesses must complete several foundational requirements:

1. Company Registration
   • Valid company registration certificate
   • Tax registration (PAN/VAT)
   • Bank account establishment
2. Documentation Assembly
   • Company registration certificate
   • Tax clearance certificate
   • Bank recommendation letter
   • Authorized capital verification

Phase 2: Online Application Process

To register for an EXIM code in Nepal, you can follow these steps: Visit the website of the Department of Customs, Government of Nepal, and navigate to the ‘EXIM Code Registration’ section.

Required Documents for EXIM Code:

• Recommendation from the bank where the applicant has an account
• Company registration certificate
• Tax registration documents
• Authorized representative identification
• Business plan and product details

Phase 3: Processing and Approval

Processing timelines vary based on application completeness and documentation accuracy. Standard processing requires 7-15 working days for complete applications.

EXIM Code Renewal Process

The EXIM Code needs to be regularly updated on an annual basis with Bank Guarantee. Annual renewal maintains trading authorization and ensures continued compliance.

Product Registration by Category

1. Pharmaceutical Product Registration

Government of Nepal established Department of Drug Administration (DDA) in 1979 A.D (2036/07/01 B.S.) erstwhile under Ministry of forest & soil conservation and went under Ministry of Health and population after Poush, 2041 B.S.

Drug Registration Requirements

Pharmaceutical product registration demands comprehensive scientific documentation:

Essential Documentation:

• Product dossier with quality, safety, and efficacy data
• Manufacturing authorization certificates
• Good Manufacturing Practice (GMP) compliance
• Clinical trial data (if applicable)
• Product samples for laboratory testing

Registration Categories

Product Type	Processing Time	Validity Period	Renewal Requirements
Generic Medicines	90-180 days	5 years	Periodic safety updates
New Drug Applications	180-365 days	5 years	Post-marketing surveillance
Medical Devices	60-120 days	3-5 years	Technical documentation updates
Ayurvedic Medicines	45-90 days	5 years	Quality control certificates

2. Food Product Registration

Food product registration ensures consumer safety and maintains quality standards throughout the supply chain.

Food Registration Process

Documentation Requirements:

• Food product composition details
• Manufacturing process specifications
• Nutritional information analysis
• Packaging and labeling compliance
• Shelf-life study reports

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Food Safety Standards

Food product standards are generally set under the Food Act and Nepal Standard (Certification Mark) Act, ensuring comprehensive quality control measures.

3. Consumer Product Registration

Consumer goods require registration through the Nepal Bureau of Standards and Metrology for market entry authorization.

Standards Compliance

Products must demonstrate compliance with relevant Nepal Standards or international equivalents:

• Safety testing reports
• Performance evaluation certificates
• Environmental impact assessments
• Quality management system documentation

4. Agricultural Product Registration

Agricultural products, including seeds, fertilizers, and pesticides, require specialized registration through agricultural authorities.

Seed Registration Process

• Variety testing and evaluation
• Field trial documentation
• Genetic purity verification
• Disease resistance certification

Import Procedures and Requirements

Import Authorization Process

Submit goods to customs for clearance, including any applicable customs duties and taxes after completing necessary documentation requirements.

Pre-Import Requirements

1. EXIM Code Registration
   • Valid import authorization
   • Product-specific import permits
   • Quality standards compliance
2. Product Registration
   • Regulatory approval for controlled products
   • Standards certification
   • Safety compliance verification

Import Documentation

Essential Import Documents:

• Commercial invoice
• Packing list and bill of lading
• Import license (if required)
• Product registration certificates
• Standards compliance certificates
• Insurance documentation

Import Duty and Tax Structure

Product Category	Import Duty Rate	VAT Rate	Additional Charges
Raw Materials	0-10%	13%	Customs processing fee
Finished Goods	10-80%	13%	Service charges
Luxury Items	80-200%	13%	Excise duty applicable
Essential Goods	0-5%	13%	Minimal processing fees

Export Procedures and Requirements

Export Authorization Framework

Export procedures require coordination between multiple agencies ensuring product quality and regulatory compliance.

Export Documentation Process

Prepare export documentation, including the commercial invoice, packing list, export license (if required), and bill of lading.

Required Export Documents:

• Export permit (if required)
• Certificate of origin
• Quality inspection certificates
• Phytosanitary certificates (for agricultural products)
• Export invoice and packing list

Export Incentives and Support

Nepal provides various export promotion incentives:

• Cash incentive schemes
• Duty drawback provisions
• Export credit facilities
• Trade promotion support

Digital Trade Facilitation

Nepal has modernized trade procedures through digital platforms improving efficiency and transparency.

Nepal National Single Window (NNSW)

The integrated digital platform streamlines trade procedures by connecting multiple agencies through unified submission systems.

Digital Platform Benefits:

• Single-point application submission
• Real-time processing status tracking
• Reduced documentation requirements
• Faster approval timelines
• Electronic certificate issuance

Online Services Available

• EXIM code registration and renewal
• Import/export permit applications
• Product registration submissions
• Standards certification requests
• Customs clearance processing

Recent Regulatory Updates

Export and Import (Regulation) Act, 2025

The proposed bill, titled the Export and Import (Regulation) Act, 2025, includes measures to regulate the massive import of goods that negatively impact domestic industries and curb illegal trade practices.

Key provisions include:

• Enhanced domestic industry protection
• Stricter import regulation measures
• Improved quality control requirements
• Streamlined export promotion policies

Fee Structure and Costs

Product Registration Fees

Registration Type	Government Fee	Processing Fee	Annual Renewal
Drug Registration	NPR 5,000-25,000	NPR 2,000-8,000	NPR 2,000-10,000
Food Registration	NPR 2,000-10,000	NPR 1,000-5,000	NPR 1,000-5,000
Standards Certification	NPR 3,000-15,000	NPR 1,500-6,000	NPR 1,500-7,500
EXIM Code Registration	NPR 1,000-5,000	NPR 500-2,000	NPR 1,000-3,000

Professional Service Costs

Additional expenses typically include:

• Legal consultation fees: NPR 10,000-50,000
• Technical documentation preparation: NPR 5,000-25,000
• Laboratory testing charges: NPR 3,000-20,000
• Translation and notarization: NPR 500-3,000

Common Compliance Challenges

Documentation Issues

Incomplete or incorrect documentation represents the primary cause of registration delays:

• Insufficient technical documentation
• Missing quality control certificates
• Inadequate safety testing reports
• Incorrect application formatting

Inter-Agency Coordination

Multiple authority involvement creates coordination complexities:

• Different requirements from various agencies
• Communication delays between departments
• Conflicting approval timelines
• Inconsistent application procedures

Quality Standards Compliance

Meeting international quality standards requires significant preparation:

• Laboratory testing facility access
• Technical expertise requirements
• Equipment calibration needs
• Continuous compliance monitoring

Renewal and Maintenance Requirements

Registration renewal requirements vary by product type. Most registrations need renewal every 1-5 years, with pharmaceuticals typically requiring renewal every 5 years and food products every 1-2 years.

Renewal Timeline Management

Critical Renewal Periods:

• Submit renewal applications 90 days before expiry
• Maintain continuous registration validity
• Update technical documentation regularly
• Complete post-market surveillance requirements

Compliance Monitoring

Ongoing obligations include:

• Quality control maintenance
• Adverse event reporting
• Market surveillance cooperation
• Standards compliance verification

Penalties and Enforcement

Penalties include fines up to NPR 500,000, product seizure, business license suspension for non-compliance with registration requirements.

Violation Categories

Violation Type	Penalty Range	Additional Consequences
Unregistered product marketing	NPR 50,000-500,000	Product seizure
Quality standards non-compliance	NPR 25,000-250,000	Registration suspension
Documentation fraud	NPR 100,000-1,000,000	Criminal prosecution
Import without proper authorization	NPR 75,000-750,000	Trading license cancellation

Frequently Asked Questions (FAQs)

Conclusion

Successfully navigating Nepal’s product registration and import-export procedures requires comprehensive understanding of regulatory requirements across multiple agencies. The country’s evolving digital infrastructure continues improving process efficiency while maintaining strict quality and safety standards.

Businesses benefit significantly from professional consultation and careful compliance planning throughout registration processes. Proper documentation preparation, timeline management, and ongoing compliance monitoring ensure sustainable market access and operational success.

The regulatory framework continues modernizing through digital transformation initiatives and policy updates. Staying informed about current requirements and maintaining proactive compliance approaches ensures continued market participation and business growth opportunities.

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This comprehensive guide provides current information as of 2025. Regulatory requirements may change, and individual circumstances vary. Consult with qualified regulatory consultants and legal professionals for personalized guidance regarding specific registration requirements.