NMRA Monthly fee for Medicines - Effective from 01/11/2020 to 30/11/2020
Dollar rates are converted at the selling rate on last working day of the preceding month (29.10.2020) which was published by the Central Bank of Sri Lanka.
| Daily Exchange Rates | 2020/10/29 | |||||
| Currency | Buying Rate (Rs.) | Selling Rate (Rs.) | ||||
| Dollar (USA) | 182.1300 | 186.4500 | ||||
| (I) Processing Fees | ||||||
| Type of evaluation | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| New Molecule Entity (NCE) | Part 1-Initial decision on application (process or decline) | 500 | 93,225.00 | 7,458.00 | - | 100,683.00 |
| Part 2 - Evaluation (if accepted) | 1500 | 279,675.00 | 22,374.00 | - | 302,049.00 | |
| New Dosage Form | 1000 | 186,450.00 | 14,916.00 | - | 201,366.00 | |
| New Product (Existing chemicals) | Foreign | 750 | 139,837.50 | 11,187.00 | - | 151,024.50 |
| Local - Category A | 500 | 93,225.00 | 7,458.00 | - | 100,683.00 | |
| Local - Category B | 200 | 37,290.00 | 2,983.20 | - | 40,273.20 | |
| New Combination Product | 1500 | 279,675.00 | 22,374.00 | - | 302,049.00 | |
| Therapeutic Biological and Biotechnological Product | 2000 | 372,900.00 | 29,832.00 | - | 402,732.00 | |
| Application for Registration renewal after 5 years | Foreign | 750 | 139,837.50 | 11,187.00 | - | 151,024.50 |
| Local - Category A | 500 | 93,225.00 | 7,458.00 | - | 100,683.00 | |
| Local - Category B | 200 | 37,290.00 | 2,983.20 | - | 40,273.20 | |
| Application for Manufacturing Plant (MP) approval - Foreign | 2000 | 372,900.00 | 29,832.00 | - | 402,732.00 | |
| (II) Fees for additional data evaluation | ||||||
| Type of evaluation | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| Additional data evaluation | Foreign | 500 | 93,225.00 | 7,458.00 | - | 100,683.00 |
| Local - Category A | 200 | 37,290.00 | 2,983.20 | - | 40,273.20 | |
| Local - Category B | 100 | 18,645.00 | 1,491.60 | - | 20,136.60 | |
| Additional data for MP Evaluation | 500 | 93,225.00 | 7,458.00 | - | 100,683.00 | |
| Variations that require review | 200 | 37,290.00 | 2,983.20 | - | 40,273.20 | |
| (III) Processing fees for Clinical Trial | ||||||
| Type of Evaluation | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| Industry Sponsored | 1000 | 186,450.00 | 14,916.00 | - | 201,366.00 | |
| Local Investigator Sponsored | Free of Charge | |||||
| Academic with International Sponsorship | 250 | 46,612.50 | 3,729.00 | - | 50,341.50 | |
| Amendments that require review | 250 | 46,612.50 | 3,729.00 | - | 50,341.50 | |
| (IV) Fees for Certificates of Registration | ||||||
| Types of Registration Certificates | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| Certificate of Registration for five years | Foreign | 400 | 74,580.00 | 5,966.40 | 2,000.00 | 82,546.40 |
| Local Category A | 200 | 37,290.00 | 2,983.20 | 2,000.00 | 42,273.20 | |
| Local Category B | 100 | 18,645.00 | 1,491.60 | 1,864.50 | 22,001.10 | |
| Provisional Registration (may be issued for a maximum of two years) | Foreign | 200 | 37,290.00 | 2,983.20 | 2,000.00 | 42,273.20 |
| Local Category A | 100 | 18,645.00 | 1,491.60 | 1,864.50 | 22,001.10 | |
| Local Category B | 50 | 9,322.50 | 745.80 | 932.25 | 11,000.55 | |
| Duplicate Copy of Registration Certificate | 250 | 46,612.50 | 3,729.00 | 2,000.00 | 52,341.50 | |
| Amendement of Registration Certificate | 100 | 18,645.00 | 1,491.60 | 1,864.50 | 22,001.10 | |
| (V) Fees for License | ||||||
| Types of licenses | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| Sample Import License | 100 | 18,645.00 | 1,491.60 | 1,864.50 | 22,001.10 | |
| Import License | 100 | 18,645.00 | 1,491.60 | 1,864.50 | 22,001.10 | |
| Manufacturing License (Local) | Category A | 100 | 18,645.00 | 1,491.60 | 1,864.50 | 22,001.10 |
| Category B | 50 | 9,322.50 | 745.80 | 932.25 | 11,000.55 | |
| Amendment of License | 100 | 18,645.00 | 1,491.60 | 1,864.50 | 22,001.10 | |
| (VI) Fees for Other Approvals | ||||||
| Type of Approval | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| Formulation Approval of local manufacturer | 25 | 4,661.25 | 372.90 | - | 5,034.15 | |
| Approval for Packaging / Repackaging | 50 | 9,322.50 | 745.80 | - | 10,068.30 | |
| Submission/ approval fee for Waiver of Registration | Invoice value USD 2,000 or below | 50 | 9,322.50 | 745.80 | - | 10,068.30 |
| Invoice value USD 2,000-USD 15,000 | 100 | 18,645.00 | 1,491.60 | - | 20,136.60 | |
| Invoice value USD 15,000 or above | 200 | 37,290.00 | 2,983.20 | - | 40,273.20 | |
| Any Clarification Letter | 10 | 1,864.50 | 149.16 | - | 2,013.66 | |
| WHO GMP certificate | 100 | 18,645.00 | 1,491.60 | 1,864.50 | 22,001.10 | |
| Certificate of Pharmaceutical Product (COPP) | 50 | 9,322.50 | 745.80 | 932.25 | 11,000.55 | |
| Free Sale Certificate | 50 | 9,322.50 | 745.80 | 932.25 | 11,000.55 | |
| Agency Transfer per each party | Manufacturer | 1000 | 186,450.00 | 14,916.00 | - | 201,366.00 |
| Each new marketing authorization holder | 1000 | 186,450.00 | 14,916.00 | - | 201,366.00 | |
| (VII) Fees for Analysis | ||||||
| Analysis | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| Biological Test | 250 | 46,612.50 | 3,729.00 | - | 50,341.50 | |
| Microbiological Test | 250 | 46,612.50 | 3,729.00 | - | 50,341.50 | |
| Assay Test (Chemical, Microbiological, Biological) | 250 | 46,612.50 | 3,729.00 | - | 50,341.50 | |
| Limit Test (performed using Analytical Equipment - HPLC,AAS etc.) | 250 | 46,612.50 | 3,729.00 | - | 50,341.50 | |
| Dissolution Test | 250 | 46,612.50 | 3,729.00 | - | 50,341.50 | |
| Three tests or less than three tests | i). If all three tests are in categories (a), (b), (c), (d) & (e) specified above | 750 | 139,837.50 | 11,187.00 | - | 151,024.50 |
| (ii). Otherwise | 500 | 93,225.00 | 7,458.00 | - | 100,683.00 | |
| Four tests or more than four tests | (i). If all four tests or more thanfour tests are in the categories (a), (b), (c), (d) & (e) specified above | 1500 | 279,675.00 | 22,374.00 | - | 302,049.00 |
| (ii). Otherwise | 1000 | 186,450.00 | 14,916.00 | - | 201,366.00 | |
| Single Test | Test other than the categories (a), (b), (c), (d) & (e) specified above | 175 | 32,628.75 | 2,610.30 | - | 35,239.05 |
| (VIII) Fees for License to deal in Medicines in Retail Pharmacies, Wholesale Establishments and Transporting of Medicines | ||||||
| Type | Fee (USD) | Amount in (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| Wholesale License | 60 | 11,187.00 | 894.96 | 1,118.70 | 13,200.66 | |
| Retail License | 45 | 8,390.25 | 671.22 | 839.03 | 9,900.50 | |
| Transport License | 30 | 5,593.50 | 447.48 | 559.35 | 6,600.33 | |
| Amended License | 30 | 5,593.50 | 447.48 | 559.35 | 6,600.33 | |
| (IX) Fee for Good Manufacturing Practice Inspection (GMP) - Local | ||||||
| Type | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| A Manufacturing site | Category A | 300 | 55,935.00 | 4,474.80 | - | 60,409.80 |
| Category B | 100 | 18,645.00 | 1,491.60 | - | 20,136.60 | |
| Repackaging site | 100 | 18,645.00 | 1,491.60 | - | 20,136.60 | |
| (X) Fee for Good Manufacturing Practice Inspection (GMP) - Foreign | ||||||
| Country | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| SAARC Countries | 15000 | 2,796,750.00 | 223,740.00 | - | 3,020,490.00 | |
| Other Countries | 20000 | 3,729,000.00 | 298,320.00 | - | 4,027,320.00 | |
| * Air Tickets, Visa fees and transport cost within that country should be borne by the Applicant | ||||||
| (XI) Fee for sample import license for clinical trials | ||||||
| Category | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| Fee for sample import license for clinical trials | 100 | 18,645.00 | 1,491.60 | 1,864.50 | 22,001.10 | |
| (XII) Fee for Advertisement | ||||||
| Advertisement | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
| Processing fee for Advertisement (All categories) | 1000 | 186,450.00 | 14,916.00 | - | 201,366.00 | |
| * Separate Applications should be submitted for each advertisement. | ||||||