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Product Registration in Nepal – 2025 (Updated)

Before importing goods into Nepal, it is mandatory to comply with the relevant import-related regulations set by the Ministry of Industry, Commerce and Supplies. Product registration is especially crucial for items such as food, pharmaceuticals, and other goods and services. The Food Act 2023 and Drugs Act 2035 are the primary legal instruments governing food and drug product registration in Nepal.

1. Food Product Registration in Nepal

Step 1: Obtain Recommendation from the Central Food Laboratory

Individuals intending to process or manufacture food products in Nepal must first acquire a recommendation from the Central Food Laboratory.

Step 2: Submit Application with Detailed Scheme

To obtain the recommendation, applicants must submit a comprehensive scheme outlining key details of the proposed food industry to the Central Food Laboratory. This scheme should include:

1. Nature and type of the industry
2. Required machinery
3. Technical expertise involved
4. Sanitary and hygiene arrangements
5. Types and sources of raw materials

Step 3: Scheme Evaluation and Bond Execution

The Central Food Laboratory reviews the submitted scheme. Upon necessary modifications and execution of a compliance bond, it may issue a recommendation for establishing the food industry.

Step 4: Payment of Fees

Once the food industry receives approval, a fee of NPR 200 must be paid before commencing production. If the production, sale, or distribution is to occur at multiple locations, separate applications and licenses are required for each site.

1.1. Mandatory License

As per the Food Regulation 2027 B.S., anyone involved in food processing or production in Nepal must obtain an official license.

1.2. Terms and Conditions After Registration

According to the Food Rules, the following conditions must be met once a food product is registered:

1. Individuals with communicable or contagious diseases, or those lacking cleanliness, must not be employed in the production, storage, or sale of food.
2. The premises used for food production, storage, or sale must be kept clean and well-maintained. Separate facilities must be provided for toilets, urinals, and waste disposal.
3. Producers, wholesalers, and retailers must maintain a record book that tracks the quantity of food produced, dispatched, and its destination. This book must be available for inspection when requested.
4. Food hygiene must be prioritized. Containers holding food products for sale must be properly sealed to prevent contamination from external sources.

2. Drug Product Registration in Nepal

The process of drug product registration in Nepal is administered by the Department of Drug Administration (DDA) under the Ministry of Health and Population. This department is responsible for overseeing the registration of pharmaceutical products, pharmacies, importers, and domestic pharmaceutical industries.

Steps for Drug Product Registration in Nepal

Step 1: Obtaining a Recommendation Letter for Industry Establishment

Anyone wishing to set up a drug manufacturing industry must apply to the Department of Drug Administration. Upon evaluation and if the application is found to be valid, the Department issues a recommendation letter after collecting the required fees.

Step 2: Acquiring a Product License for Manufacturing

After receiving the recommendation and establishing the industry, the applicant must request a product license from the Department. Following a formal inquiry and review, the drug is registered in the official record, and the applicant is issued a license to begin manufacturing.

Step 3: Drug Registration for Sale and Distribution

Industries that have secured the product license must apply for a sale and distribution registration certificate, submitting the following information:

1. Detailed product specifications,
2. Analysis method and lab test report from a DDA-specified laboratory,
3. A sample of the drug along with labeling and pricing,
4. Any other requirements prescribed by the Department.

If the submission meets the Department’s standards, the drug is registered and approved for sale and distribution.

Step 4: Registration Prior to Importing Drugs

For importing pharmaceutical products, an application must be submitted to the Department including:

1. A certified copy confirming the manufacturer’s compliance with Good Manufacturing Practices (GMP),
2. Product specifications and lab test reports from a recognized facility,
3. Pharmacopoeia standards,
4. A sample of the drug,
5. Any additional details requested by the Department.

For importing Ayurvedic, Homeopathic, or Traditional Medicines, the following should also be included:

1. Literature or reference materials validating the drug,
2. Drug specifications,
3. Recommendations from the relevant authority for patented products,
4. A drug sample.

Once reviewed and approved, the Department registers the product and issues a Drug Import Registration Certificate after collecting applicable fees.

2.1 Applicable Fees

According to the Drugs Regulation 2038, the following fees apply for drug product registration in Nepal:

1. Initial product license fee: NPR 200
2. Renewal fee: NPR 50

3. Required Documents for Product Import Registration in Nepal

To register imported products, especially from India, the following documents are required:

1. Authorization Letter for Customs Agent
2. Delivery Order from Terminal Management Company (TMC) for Inland Clearance Depots (ICDs)
3. Billing/Invoice Statement
4. Customs Declaration from Nepalese Customs
5. List of Packed Items

For specific product categories (such as food, plants, raw materials, or animals), supplementary documents are also necessary, including:

1. Plant quarantine or phytosanitary certificates,
2. Laboratory test reports (for food),
3. Chemical analysis reports,
4. Health certificates (for raw wool),
5. Veterinary certificates (for animals).

4. Documents Required for Product Registration (Import via India)

For importing goods into Nepal through India, the following documents are necessary for product registration:

1. BBN 4 Form issued by Nepal Rastra Bank (the Central Bank of Nepal)
2. Shipping Bill or Delivery Order
3. Insurance Certificate
4. Authenticated Copy of Letter of Credit (L/C) or evidence of Advance Payment
5. Certificate of Origin (COO) – Required only for goods eligible for special tariff benefits based on their origin
6. Original Customs Transit Declaration (CTD)
7. Delivery Order from Terminal Management Company (TMC) for Inland Container Depots (ICDs)
8. Enterprise Registration Certificate
9. Commercial Invoice
10. Authorization Letter from the Customs Authority
11. White Copy of Nepalese Customs Declaration
12. Packing List
13. VAT Registration Certificate or Permanent Account Number (PAN)
14. Wool Specification Test Report, if applicable

Additionally, for specialized types of cargo, the following supplementary documents may be required:

1. Plant quarantine/health/phytosanitary certificates for plant-based items
2. Laboratory test reports for food products
3. Chemical analysis reports, as applicable
4. Health certificates for raw wool
5. Veterinary certificates for animals