Fiji Ministry of Health and Medical Services — Pharmacy and Therapeutics Section
Fiji PTS · Fiji · oceania
Fiji's Pharmacy and Therapeutics Section (under the Ministry of Health and Medical Services) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- oceania
- Country
- Fiji
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.health.gov.fj
Relevant Regulation Codes
- Fijian Medicinal Products Act and subsidiary regulations
- Fijian national medical device regulatory framework
Prescriber Requirements
- Fiji Medical Council–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Ministry of Health registration as applicable; English-language labelling. Standard cold-chain conditions, with logistical constraints typical for Pacific island states.
Import/Export Rules
Ministry of Health import authorisation; Biosecurity Authority of Fiji clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Not covered under public insurance schemes for leech therapy specifically.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. Pacific island regulatory frameworks often rely on regional harmonisation with Australia (TGA) and New Zealand (Medsafe); the exact mechanism has not been independently mapped by ASH.
Related Jurisdictions
TGA — Australia
Australia's therapeutic-goods regulator — medicinal leeches included in the Australian Register of Therapeutic Goods (ARTG) as Class IIa medical device with import permit oversight.
Medsafe — New Zealand
New Zealand's medicines and medical-devices regulator — operates under the Medicines Act 1981 with leech therapy regulated as a notified medical device and biosecurity-controlled import.
WHO — Global (United Nations specialised agency)
Global health authority — Hirudo medicinalis listed in the WHO Monographs on Selected Medicinal Plants (informational) and embedded in the Traditional Medicine Strategy 2014–2023 and 2025–2034 successor.
PNG NDoH-MC — Papua New Guinea
Papua New Guinea's National Department of Health, Medicines and Cosmetics Branch — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework as appropriate.