The Therapeutic Goods Act and Good Manufacturing License requirements are the prime legislation that covers the requirements for the manufacture and supply of medicinal products – which includes the full range of medical gases supplied by BOC Healthcare.
The Therapeutic Goods Act and Therapeutic Goods Regulations cover requirements for the licensing and registering of medicinal products and define Good Manufacturing Practices (GMP) to control their manufacture. The regulations are designed to protect patient safety, ensuring that the products are safe, efficacious and of an appropriate level of quality.
Medicinal products are classified when registered to define the control required when supplying the patient, ranging from those products available over the counter (OTC) without a prescription, to those which can only be supplied under prescription to a named patient.