Department of Drug Administration

Requirements for Registration of Ayurvedic and Homeopathic Products

1. Registration of Manufacturer:
Application for registration will be accepted only from the manufacturers that are WHO-GMP certified.

The following documents should be submitted through the authorized Nepalese importer for the company (manufacturer) registration.

1.	An application by the company for the company registration
2.	Letter of authority to the importer issued by the responsible person of the company
3.	Site Master File (as per PICS guidelines or guidelines provided by Department of Drug Administration, Nepal)
4.	Up-to-date manufacturing license issued by drug control authority
5.	List of products and dosage forms intended to be registered
6.	Letter of warranty (in format provided by Department of Drug Administration, Nepal)
7.	Latest GMP internal audit report
8.	Photocopy of wholesale registration of Nepalese importer
9.	A complete set of documents for at least one product needed for product registration, as mentioned below.

If the submitted documents are satisfactory, the company will be listed for the audit of manufacturing site. The company will have to pay USD 1500.00 (for the SAARC country) or USD 2500.00 (for countries other than SAARC) as inspection fee. The company will be audited after the decision of the Government of Nepal. If audit team is satisfied with GMP implementation status, the company will be registered on the payment of NRs 50000.00 (for the SAARC country) or NRs. 80000.00 (for countries other than SAARC). If the team is not satisfied about GMP implementation status, registration will not be granted and no process for re-audit will be initiated for at least two years.

After the company registration, this department can process for the product registration. The registration fee for the product registration is Rs. 2400 and Rs. 300 for import recommendation letter.

2. Registration of Product
The following documents should be submitted through the Nepalese importer for the product registration.

1.	Schedule 4 'Ga' Application form for product registration as per Registration Regulation of Drug Act 1978. (Available at the department and to be filled by Nepalese importer)

2.	Schedule 6 Application form for product recommendation letter as per Registration Regulation of Drug Act 1978. (Available at the department and to be filled by Nepalese importer)

3.	Attested copy of Valid Certificate of Pharmaceutical Products (CPP) as recommended by WHO (Attested by Drug Regulatory Authority or Notary Public).

4.	Detail formulation including excipients, color, flavor etc.
5.	Product specification
6.	Methods of analysis
7.	Samples of the product (2-unit pack), labels and carton.
8.	Analytical report from own lab and from any of the laboratories for the same batch: Government laboratory of the exporting country or Nepal, Nepalese Laboratories- FDC Laboratory Pvt. Ltd., Zest Laboratories Pvt. Ltd., Multi Pharmaceuticals Laboratories Pvt. Ltd. The above documents are to be indexed and submitted in an index file. The Product Registration Document for each product should be submitted in separate individual file.

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