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Requirements
for Registration of Modern Medicines |
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1. Registration of Manufacturer:
The following documents should be submitted through the authorized
Nepalese importer for the company (manufacturer) registration.
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| 1.
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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 PIC/S
guidelines or guidelines provided by Department
of Drug Administration, Nepal) |
| 4. |
Up-to-date manufacturing licence
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
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| 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. |
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If the submitted
documents are satisfactory, 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). The company
will be audited on the payment of USD 1500.00 for SAARC country
or USD 2500.00 for other than SAARC countries. Audit will
not be done for the industries situated in USA, Canada, European
Union, Australia and New Zealand or for re-audit of products
to be exported to those countires.
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.
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2. Registration of Product
The following documents should be submitted through the Nepalese
importer for the product registration. |
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| 1.
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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) |
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| 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) |
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| 3. |
Attested copy of
Valid Certificate of Pharmaceutical Products (CPP)
as recommended by WHO (Attested by Drug Regulatory
Authority or Notary Public). |
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| 4. |
Detail formulation including
recipients, color, flavor etc. |
| 5. |
Product specification |
| 6. |
Methods of analysis |
| 7. |
Samples of the product (2-unit
pack), labels and cartoon |
| 8.
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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 |
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9. |
Real time stability study report for at least 2
years or for shelf life period if less than two
years. |
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If the product
has to be registered as per the article 2 of the “Requirements
for Registration of Foreign Pharmaceutical Manufacturer to
Export their Products to Nepal “ section, product registration
certificate of the importing country has to be submitted.
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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