Proposed fees for natural health products: Annex C, International comparison of NHP regulation

Table 10: Comparison of fees by select NHP type, Canada, and other international regulators
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)
approx. $22,103 to $34,105 CAD
national level (ex. Ireland)

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),
approx. $0 to $32,881 CAD

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
Standard: 45 to 150 working days

Submission review (£517 to £1,312 depending on if components have already been assessed)
approx. $856 to $2,172 CAD

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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