Regulatory

Regulatory and Compliance.

Compliance as an operational discipline, embedded in every process.

DNH Logistics operates as a NSW wholesale-licensed distributor within a compliance framework built for regulated goods. Where market entry requires ARTG sponsorship and pharmacovigilance, we coordinate specialist partners rather than claim those legal roles ourselves — so the accountability sits where it legally belongs, and you deal with one coordinated arrangement. 

What we operate:

  • NSW wholesale drug licence — Schedules 2–8.
  • Good Wholesaling Practice (GWP) and Good Distribution Practice (GDP) aligned operations.
  • ISO 9001 certified quality management.
  • Quality & Technical Agreement execution with overseas manufacturers.
  • GMP evidence management and monitoring for manufacturers.
  • Recall management support and TGA notification coordination.
  • GS1 / National Product Catalogue readiness.

What we coordinate (through specialist partners)

ARTG registration and Australian sponsor-of-record.

Pharmacovigilance — an Australian pharmacovigilance contact, adverse-event reporting and safety reporting obligations.

Comparable Overseas Regulator (COR) pathway strategy for FDA/EMA-approved products.

Discuss a compliant operating model.
Talk to us