All importers of medicine are hereby informed to submit following documents for the acceptance of sample import license applications of medicines.

1. Schedule XI

should comply with the Regulation 59(1) of the gazette No. 2145/1 and following should be included

• Actual manufacturing site address
• Importer with the address
• Correct generic name dosage from and strength
• Brand name (if any)
• Requested quantity
• Pack size & Pack type

Purpose of applying SIL should correctly selected should be originally signed by the applicant

2. Copy of company profile Approval Latter
3. Letter of Authorization
4. Price details
5. Registration Certificate (If applicable) (For Agency transferred, Site transferred or Existing products )
6. Agency Transfer Letter (If Applicable)
7. MEC approval letter for New Molecular Entities (This is mandatory to proceed the Sample License applications for NMEs)

(Date: 22 December 2022)

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