Compliance & Governance

The Med-ID Governance
& SOP Framework

A 130+ page regulator-ready governance system designed to support safe, pharmacist-controlled deployment — from regulatory submission through to daily operation.

Built to remove regulatory uncertainty — not just document it.

Framework Version
v2.2
Last Reviewed
February 2026
Documentation
130+ Pages

Regulatory basis

Med-ID has developed a comprehensive governance system designed to ensure each deployment is aligned with applicable legislation, regulatory expectations, and pharmacy practice standards across Australia.

Every Med-ID deployment is pharmacist-controlled, SOP-governed, and aligned to jurisdiction-specific legislation before activation.

All systems are designed to ensure there is:

  • no autonomous supply
  • no unsupervised dispensing
  • no reclassification as vending infrastructure

Professional pharmacy activities (including dispensing and clinical decision-making) remain clearly separated from logistical functions (including secure storage and collection), with control maintained at all times through pharmacist-led Standard Operating Procedures.

Applicable legislation and frameworks

National (Commonwealth) framework

  • Health Practitioner Regulation National Law
  • Therapeutic Goods Act 1989 (Cth)
  • Privacy Act 1988 (Cth)
  • Competition and Consumer Act 2010 (Cth) (Australian Consumer Law)

State and Territory legislation

Each deployment is aligned to the relevant medicines and poisons legislation, including:

  • NSW: Poisons and Therapeutic Goods Act 1966 (NSW)
  • QLD: Medicines and Poisons Act 2019 (Qld)
  • VIC: Drugs, Poisons and Controlled Substances Act 1981 (Vic)
  • WA: Medicines and Poisons Act 2014 (WA)
  • SA: Controlled Substances Act 1984 (SA)
  • TAS: Poisons Act 1971 (Tas)
  • ACT: Medicines, Poisons and Therapeutic Goods Act 2008 (ACT)
  • NT: Medicines, Poisons and Therapeutic Goods Act 2012 (NT)

Supporting Regulations

Each Act is supported by detailed Regulations governing supply, storage, record-keeping, and supervision. Med-ID systems are designed to align with these operational requirements through SOPs and pharmacist control.

Pharmacy Practice & Professional Standards

  • State-based pharmacy legislation (premises and ownership)
  • Pharmacy Board of Australia guidelines
  • PSA Professional Practice Standards

Additional Compliance Areas

  • Work Health & Safety (WHS)
  • Electrical and installation standards
  • Planning and landlord approvals (where required)
  • Privacy and data protection

Framework pillars

01
Regulatory Compliance
  • State-by-state regulatory assessment
  • Submission documentation
  • Approval pathway guidance
  • Ongoing compliance monitoring
02
Operational SOPs
  • Pharmacist loading procedures
  • Patient access protocols
  • Incident management
  • Audit and reporting requirements
03
Security & Access
  • PIN-based patient authentication
  • Physical security standards
  • CCTV and monitoring requirements
  • Tamper detection protocols
04
Training & Support
  • Staff training requirements
  • Pharmacist competency standards
  • Ongoing support obligations
  • Framework update notifications

Regulatory distinction by product

PharmaSelf24™ and MedyBOX™ operate under different regulatory frameworks. This distinction is fundamental to the Med-ID compliance model.

PharmaSelf24™
Post-Supply Authorisation Collection
Regulatory position

PharmaSelf24™ is not a dispensing system. It is a secure collection infrastructure for prescriptions that have already been dispensed and supply-authorised by the pharmacist. No dispensing, selection, or supply occurs at the point of collection.

Key compliance requirements
  • State pharmacy authority notification or approval (jurisdiction-dependent)
  • Pharmacist responsible for all dispensing decisions
  • Full audit trail for every collection event
  • Secure PIN-based patient authentication
  • Physical security and CCTV requirements
  • SOP documentation and staff training
MedyBOX™
Retail Health & Wellness Access
Regulatory position

MedyBOX™ provides access to non-scheduled retail products only. It does not handle scheduled medicines, pharmacist-only medicines, or any product requiring pharmacist involvement. It operates as a pharmacist-curated retail access point.

Key compliance requirements
  • Product selection limited to non-scheduled items
  • Pharmacist responsible for product curation and approval
  • Standard retail compliance (Australian Consumer Law)
  • POS system integration and transaction records
  • Physical security requirements
  • No scheduled or pharmacist-only medicines permitted

State-based regulatory pathway

Pharmacy regulation in Australia is state and territory-based. Med-ID assesses each deployment against the applicable jurisdiction's requirements and provides submission guidance and documentation support.

NSW
Pharmacy Council of NSW
Active deployments
QLD
Queensland Health
Active deployments
SA
Pharmacy Regulation Authority South Australia (PRASA)
Active deployments
VIC
Victorian Pharmacy Authority (VPA)
Under review
ACT
ACT Health
Under review
NT
NT Health
Under review
TAS
Pharmacy Board of Tasmania
Pathway available
WA
Pharmacy Board of WA
Pre-planning

* Regulatory status is subject to change. Med-ID provides current guidance at the time of each pharmacy's assessment. Contact us for the latest position in your jurisdiction.

Regulatory alignment and ongoing engagement

Med-ID actively works directly with relevant state and territory pharmacy regulatory authorities — including bodies such as the Pharmacy Council of NSW, the Victorian Pharmacy Authority (VPA), and the Pharmacy Regulation Authority South Australia (PRASA), as well as State and Territory Health Departments responsible for pharmacy regulation in their respective jurisdictions.

This includes:

  • direct engagement with regulators and authorities
  • formal submissions and supporting documentation
  • operational alignment prior to and during deployment

While there is clear alignment with existing legislative frameworks, Med-ID continues to work collaboratively with each state and territory body to ensure local requirements, interpretations, and expectations are fully met.

As regulatory frameworks continue to evolve in response to emerging pharmacy infrastructure, Med-ID remains committed to transparent collaboration, pharmacist-led control, and ongoing compliance.

For the most current regulatory position or jurisdiction-specific guidance, please contact our team directly.

Contact the team

Request the full Governance Framework

The 130+ page Med-ID Governance & SOP Framework is available to pharmacy owners and regulatory advisers on request. Book a Discovery Call to discuss your jurisdiction and implementation pathway.

Book a Discovery Call