Product Registration in Nepal (2080)

Before importing goods in Nepal, import-related rules and regulations are required to be fulfilled by the Ministry of Industry, Commerce and Supplies. Product Registration in Nepal prominently applies to Foods, Drugs, and other goods and services. Food Act 2023 and Drug Act 2035 are Nepal’s prevailing Drug and Food Product Registration Laws.

1. Food Product Registration in Nepal

Department of Food Technology and Quality Control, one of the departments under the Ministry of Agriculture and Livestock Development

1.1 License to be Obtained

Food Regulation 2027 B.S. has codified that a License is required for Processing and Producing Foods in Nepal.

Step 1: Obtain a Recommendation from the Central Food Laboratory

An Individual who intends to produce or process any Food in Nepal must first obtain a recommendation from the Central Food Laboratory in Nepal.

Step 2: Application Submission with Comprehensive Scheme

To secure the above recommendation, the individual must draft a comprehensive scheme detailing the following aspects of the intended industry and submit it to the central food laboratory:

  1. Type of industry
  2. Machinery required
  3. Technical skills
  4. Sanitation provisions
  5. Types of raw materials and their sources.

Step 3: Review of the Proposed Scheme

The central food laboratory will review the proposed food industry scheme, make necessary adjustments, execute a bond for compliance, and recommend issuing the industry establishment license.

Step 4: Payment

After the Food Industry has been successfully allowed from the Central Food Laboratory, they must pay NPR 200 before starting Food Production. A person who intends to produce, sell, or distribute food in more than one place must make a separate application and obtain the license, as referred to in this Chapter, for each place.

1.2 Terms and Conditions

The Terms and Conditions after the Product has been registered are as follows as provided in Food Rules:

  1. Not to engage anyone suffering from a communicable or contagious disease or is dirty in the production, storage, or sale of the food.
  2. To always keep the places for the production, storage, or sale of food clean and satisfactory; and there shall be separate places for a toilet, urinal, and collection of wastes or useless materials.
  3. The producers or whole sellers or sellers have to maintain and show, wherever required, a registration book indicating the quantity of the food they have produced, the quantity of food dispatched for sale or distribution, and the places where the food has been sold and distributed.
  4. Proper attention has to be paid to food hygiene, and a container of food prepared or held for sale has to be closed properly so that external elements cannot enter the container.

2. Drug Product Registration in Nepal

Drug Product Registration in Nepal is governed and regulated by the Department of Drug Administration under the Ministry of Health and Population. It deals with the Registration of Drugs, Registration of Pharmacies, Registration of Importers, and Registration of Domestic Industries related to Drugs.

The Process of Drug Product Registration in Nepal:

Step 1: Obtain a Recommendation Letter to Establish the Drug Industry

If a person intends to obtain a recommendation letter to establish a drug industry, such person shall make an application to the Department of Drug Administration if the Department finds it reasonable to issue a recommendation letter to establish that drug industry, it shall issue the recommendation letter to the applicant by collecting the Required Fees.

Step 2: Obtain a Product License to Manufacture Drug

A person who has already established a drug industry after obtaining the recommendation letter shall apply to the Department to obtain the product license to manufacture the drug. After an application, the Department shall make necessary inquiries into the matter, register such drugs in the registration book, and issue the production license to the applicant.

Step 3: Registration of Drugs for Sale and Distribution

An industry having obtained the production license shall make an application to the Department setting out the following details for the registration of the sale and distribution of such drug:

(a) Product specification of the manufactured drug,

(b) Method of analysis of the manufactured drug and test report conducted by a laboratory specified by the Department,

(c) A sample of the manufactured drug, along with the label indicating its price,

(d) Other matters specified by the Department.

If the Department deems it proper to sell and distribute the drug mentioned in the application, it shall register such drug and issue the drug sale and distribution registration certificate.

Step 4: Registration before the Importation of the Drug

A person who intends to import a drug shall make an application to the Department, setting out the following details of the drug that he intends to import for the drug import registration certificate:

(a) A certified copy of the certificate issued by an authentic body certifying that the manufacturer has followed good manufacturing practices,

(b) Product specification of the manufactured drug,

(c) Method of analysis of the manufactured drug and test report conducted by a laboratory specified by the Department,

(d) Pharmacopoeia standard,

(e) A sample of the manufactured drug,

(f) Other matters specified by the Department.

For Making an Application to import any Ayurvedic, Homeopathic, and other traditional drug, the following details shall be attached:

(a) Details mentioned in the book or literature,

(b) Product specification of the manufactured drug,

(c) Recommendation of the concerned body in the case of a patented drug,

(d) A sample of the manufactured drug

If the Department deems it proper to import the drug mentioned, it shall register such drug in the Format and issue the certificate by collecting the Drug Registration Fees.

2.1 Required Fees

The Product License Fees for Drug Product Registration in Nepal is NPR 200 As Initial Fees and NPR 50 as Renewal Fees according to the Drugs Regulation 2038.

3. Required Documents for Product Registration in Nepal

The Product Registration in Nepal for Import requires the Document listed below:

  1. Documents for Product Registration (Import) from India
  2. Customs Agent Authorization Letter
  3. Terminal Management Company (TMC) Delivery Order for Inland Clearance Depots (ICDs)
  4. Billing Statement
  5. Declaration from Nepalese Customs
  6. List of Packed Items
  7. Supplementary documentation for specialized cargo includes plant quarantine/health/phytosanitary certificates for plants, laboratory test reports for food products, chemical analysis reports, health certificates for raw wool, and veterinary certificates for animals, as required.

4. Documents for Product Registration (Import Via India)

The Documents required for Product Registration of Import Via India are as follows:

  1. Nepal Rastra Bank’s (Central Bank) BBN 4 Form
  2. Shipping Bill/Delivery Order
  3. Insurance Certificate
  4. Authenticated Copy of Letter of Credit (L/C) or Advance Payment
  5. Certificate of Origin (COO) – Not mandatory, except for imported goods eligible for special tariff concessions based on their origin
  6. Original Customs Transit Declaration (CTD)
  7. Terminal Management Company (TMC) Delivery Order for Inland Container Depots (ICDs)
  8. Enterprise Registration Certificate
  9. Commercial Invoice
  10. Customs Authority Authorization Letter
  11. Nepalese Customs Declaration (White Copy)
  12. Packing List
  13. Value Added Tax (VAT) Registration Certificate/PAN
  14. Wool Specification Test Report, if applicable
  15. Supplementary documentation for specific cargo includes plant quarantine/health/phytosanitary certificates for plants, laboratory test reports for food products, chemical analysis reports, health certificates for raw wool, and veterinary certificates for animals, as required.

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