NMRA current fee schedule, reviewed for 2026, in USD.
17 fee lines100% exact amountscurrency USDFX rates 2026-08-31reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| New application processing fee - foreign applicant | USD 1,000 | $1,000 | Per application | Verified |
| New application processing fee - local applicant Local Category A USD 750; Local Category B USD 250. | USD 250–750 | $250–$750 | Per application | Verified |
| Registration renewal after five years Foreign USD 750; Local Category A USD 500; Local Category B USD 200. | USD 200–750 | $200–$750 | Every 5 years | Verified |
| Certificate of registration valid for five years Foreign USD 400; Local Category A USD 200; Local Category B USD 100. A LKR 2,000 stamp duty applies to each certificate. | USD 100–400 | $100–$400 | Per certificate | Verified |
| Provisional registration certificate (maximum two years) Foreign USD 200; Local Category A USD 100; Local Category B USD 50. | USD 50–200 | $50.00–$200 | Per certificate | Verified |
| Additional data evaluation Foreign USD 500; Local Category A USD 200; Local Category B USD 100. | USD 100–500 | $100–$500 | Per evaluation | Verified |
| Variation that requires review | USD 200 | $200 | Per variation | Verified |
| Foreign manufacturing plant approval processing fee Additional data for plant evaluation: USD 300. | USD 1,500 | $1,500 | Per plant | Verified |
| Foreign GMP inspection SAARC countries USD 15,000; other countries USD 20,000. Air tickets, visa fees, and in-country transport are borne by the applicant. | USD 15,000–20,000 | $15,000–$20,000 | Per inspection | Verified |
| Local GMP inspection Manufacturing site Category A USD 300, Category B USD 100; packaging/repackaging site USD 100. | USD 100–300 | $100–$300 | Per inspection | Verified |
| Sample import licence | USD 100 | $100 | Per licence | Verified |
| Import licence | USD 100 | $100 | Per licence | Verified |
| Free-sale certificate | USD 50 | $50.00 | Per certificate | Verified |
| WHO GMP certificate | USD 100 | $100 | Per certificate | Verified |
| Clinical trial processing fee Industry sponsored USD 1,000; academic with international sponsorship USD 250; local investigator sponsored free of charge. | USD 0–1,000 | $0.00–$1,000 | Per trial | Verified |
| Agency transfer Charged per manufacturer and per new marketing-authorisation holder. | USD 1,000 | $1,000 | Per party | Verified |
| Advertisement processing fee (all categories) | USD 1,000 | $1,000 | Per advertisement | Verified |
Government fees only — service and testing costs are separate- NMRA fixes device fees in US dollars and republishes the schedule monthly with the LKR conversion at the Central Bank selling rate of the last working day of the preceding month; the USD amounts recorded here are the schedule's own base fees.
- Every line additionally carries 18% VAT and a 2.5% Social Security Contribution Levy, and registration certificates and licences carry a LKR 2,000 stamp duty.
- Formulation approval for local manufacturers and local investigator-sponsored clinical trials are stated free of charge.
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Exact amounts verified against the NMRA fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:sri-lanka:new-application-foreign