Proposed fees for natural health products: Annex C, International comparison of NHP regulation
NHP product | Canada (CAD) | Australia (AUD) CAD/AUD 0.91 | UK (GBP) CAD/GBP 1.66 | EU (EUR) CAD/EUR 1.43 | US (USD) CAD/USD 1.36 |
---|---|---|---|---|---|
Herbal remedies | NHP – Class II | Listed medicine | Traditional herbal remedy | Herbal medicinal product | Dietary supplement-drug |
Submission review $2,761 | Submission review ($1,129 to $25,240 AUD) approx. $1,027 to $22,968 CAD Standard: 45 to 150 working days |
Submission review (£2,423 to £7,269) approx. $4,013 to $12,038 CAD Processing time: 150 days |
Scientific opinion (€15,400 to €23,700) Submission review (€3,370 to €5,495) approx. $4,837 to $7,887 CAD Processing time: 210 days |
N/A | |
RTS ($542) | Annual charge ($1,200 AUD) approx. $1,097 CAD | Periodic (annual) fee (£76) approx. $126 CAD | Annual fee (€125) approx. $179 CAD | N/A | |
SL ($4,784 application, up to $23,071 annual) | Manufacturing licence ($841 AUD initial + $4,945 AUD annual) approx. $769 CAD initial + $4,521 CAD Inspection fee ($1,047 AUD/hour/inspector) approx. $957 CAD Processing time: up to 12 months |
Manufacturer's licence (£183 to £3,143 initial +£468 annual) approx. $303 to $5205 + $775 annual CAD Inspection fee (£295 to £1,615/day) $489 to $2,675 CAD Processing time: 90 days |
Manufacturer's authorization (€2,080 initial + €4,500 to €22,000 annual) approx. $2,985 initial + $6,459 to $31,575 CAD Processing time: not available |
Facility fee ($0 to $24,178 USD annually), Processing time: not available |
|
Homeopathic medicines | NHP Class I | Listed medicine | Homeopathic medicine | Homeopathic medicine | Drug |
Submission review ($1,124) Standard: 60 calendar days |
Submission review ($1,129 to $25,240 AUD) approx. $1,027 to $22,968 CAD |
Submission review (£517 to £1,312 depending on if components have already been assessed) Processing time: 150 days |
National level (ex. Ireland) Submission review (€510 to €1,685) approx. $732 to $2,291 CAD Processing time: 210 days |
Processing time: 10 months |
|
RTS ($542) | Annual charge ($1,200 AUD) approx. $1,097 CAD | Periodic (annual) fee (£76) approx. $126 CAD | Annual fee (€60) approx. $86 CAD | N/A | |
SL ($4,784 application, up to $23,071 annual) | Manufacturer's licence ($841 AUD initial +$4,945 AUD annual) approx. $769 CAD initial + $4,521 CAD Inspection fee ($1,047 AUD/hour/inspector) approx. $957 CAD Processing time: up to 12 months |
Manufacturer's licence (£183 to £3,143 initial +£468 annual) approx. $303 to $5,205 + $775 annual CAD Inspection fee (£968 to £2,655/day) approx. $1,603 to $4,397 CAD Processing time: 90 days |
Manufacturer's authorization (€2,080 initial + €1,125 annual) approx. $2,985 initial + $1,615 CAD Processing time: not available |
Facility fee ($24,178 USD annually) approx. $32,881 CAD Processing time: not available |
|
Traditional medicines | NHP Class I | Listed medicine | Traditional herbal medicine | Herbal medicinal product | Dietary supplement-Drug |
Submission review ($1,124) Standard: 60 calendar days |
Submission review ($1,129 to $25,240 AUD) approx. $1,027 to $22,968 CAD Standard: 45 – 150 working days |
Submission review (£2,423 to £7,269) approx. $4,012 to $12,038 CAD Processing time: 150 days |
National level (ex. Ireland) Submission review (€3,370 to €5,495) $4,837 to $7,887 CAD Processing time: not available |
N/A | |
RTS ($542) | Annual charge ($1,200 AUD) approx. $1,097 CAD | Periodic (annual) fee (£76) approx. $126 CAD | Annual fee (€125) approx. $179 CAD | N/A | |
SL ($4,784 application, up to $23,071 annual) |
Manufacturer's licence ($841 AUD initial +$4,945 AUD annual) approx. $769 CAD initial + $4,521 CAD Inspection fee ($1,047 AUD/hour/inspector) approx. $957 CAD Processing time: up to 12 months |
Manufacturer's licence (£183 to £3,143 initial +£468 annual) approx. $303 to $5,205 + $775 annual CAD Inspection fee (£295 to £1,615/day) approx. $457 to $2,503 CAD Processing time: 90 days |
Manufacturer's authorization (€2,080 initial + €4,500 to €22,000 annual) approx. $2,985 initial + $6,459 to $31,575 CAD Processing time: not available |
Facility fee ($0 to $24,178 USD annually) approx. $32,881 CAD Processing time: not available |
|
Sterile Saline Mist | NHP – Class III | Registered medicine | Medicine | Medicine | Dietary supplement - drug |
Submission review ($7,209) Standard: 180 calendar days |
Application and evaluation fees ($585 to $3,047 AUD + $3,355 to $38,988 AUD) approx. $535 to $2,773 CAD + $3,053 to $35,479 CAD Standard: 45 – 210 working days |
Submission review (£2,564 to £92,753) approx. $4,246 to $153,607 CAD Processing time: 150 days |
Scientific opinion (€15,400 to 23,700) approx. $22,103 to $34,105 CAD National level (ex. Ireland) Authorization (€6,120 to €51,000) approx. $7,895 to $65,790 CAD Processing time: 210 days |
N/A | |
RTS ($542) | Annual charge ($1,580 AUD) approx. $1,445 CAD | Periodic (annual) fee (£307 to £2,428) approx. $508 to $4,021 CAD | Annual fee (€730) approx. $1,044 CAD | N/A | |
SL ($4,784 application, up to $40,071 annual) |
Manufacturer's licence ($841 AUD initial + $4,945 AUD annual) approx. $769 CAD initial + $4,521 CAD Inspection fee ($1,047 AUD/hour/inspector) approx. $957 CAD Processing time: up to 12 months |
Manufacturers licence (£183 to £3,143 initial +£468 annual) approx. $303 to $5,205 initial + $775 annual CAD Inspection fee (£968 to £2,655/day) approx. $1,500 - $4,115 CAD Processing time: 90 days |
Manufacturer's authorization (€2,080 initial + €4,500 to €22,000 annual) approx. $2,985 initial + $6,459 to $31,575 CAD Processing time: not available |
Facility fee ($0 to $24,178 USD annually) approx. $32,881 CAD Processing time: not available |
|
Vitamins and Minerals | NHP – Class I | Listed medicine | Food supplement | Food supplements | Dietary supplement |
Submission review $1,124 Standard: 60 calendar days |
Submission review ($1,129 to $25,240 AUD) approx. $1,027 to $22,968 CAD Standard: 45 to 150 working days |
N/A | N/A | N/A | |
RTS $542 |
Annual charge ($1,200 AUD) approx. $1,097 CAD |
N/A | N/A | N/A | |
SL $4,784 application, up to $23,071 annual | Manufacturer's licence ($841 AUD initial +$4,945 AUD annual) approx. $769 CAD initial + $4,521 CAD Inspection fee ($1,047 AUD/hour/inspector) approx. $957 CAD Processing time: up to 12 months |
N/A | N/A | N/A |
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