NMRA Monthly fee for Medical Device - 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 |
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Currency | Buying Rate (Rs.) | Selling Rate (Rs.) | ||||
Dollar (USA) | 182.1300 | 186.4500 | ||||
(I) Processing fee | ||||||
Type | Fee (USD) | Amount (Rs.) | VAT (Rs.) @ 8% | Stamp Duty (Rs.) | Total (Rs.) | |
New Application | Foreign | 1000 | 186,450.00 | 14,916.00 | - | 201,366.00 |
Local - Category A | 750 | 139,837.50 | 11,187.00 | - | 151,024.50 | |
Local - Category B | 250 | 46,612.50 | 3,729.00 | - | 50,341.50 | |
Application for Registration renewal after five 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 | 1500 | 279,675.00 | 22,374.00 | - | 302,049.00 | |
(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 Manufacturing Plant (MP) Evaluation | 300 | 55,935.00 | 4,474.80 | - | 60,409.80 | |
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 for Foreign Manufacturers | 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 |
Local Category B | 50 | 9,322.50 | 745.80 | 932.25 | 11,000.55 | |
Ammendment 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 for local manufacturer | Free of charge | |||||
Approval for Packaging / Repackaging | 50 | 9,322.50 | 745.80 | - | 10,068.30 | |
Submission/ Approval fee for waiver of registration | Invoice value USD 2000 or below | 50 | 9,322.50 | 745.80 | - | 10,068.30 |
Invoice value USD 2,000-USD 10,000 | 100 | 18,645.00 | 1,491.60 | - | 20,136.60 | |
Invoice value USD 10,000-USD 15,000 | 200 | 37,290.00 | 2,983.20 | - | 40,273.20 | |
Invoice value USD 15,000-USD 20,000 | 500 | 93,225.00 | 7,458.00 | - | 100,683.00 | |
Invoice value USD 20,000 or above | 750 | 139,837.50 | 11,187.00 | - | 151,024.50 | |
Any clarrification 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 | |
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 | |
Three tests or less than three tests | i). If all three tests are in categories (a), (b), (c) & (d) 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 than four tests are in the categories (a), (b), (c) & (d) 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) specified above | 175 | 32,628.75 | 2,610.30 | - | 35,239.05 |
(VIII) 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 | |
A Packaging/ Repackaging site | 100 | 18,645.00 | 1,491.60 | - | 20,136.60 | |
(IX) 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 | ||||||
(X) 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 | |
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. |