Medicines

Australian Requirements

All medicinal products, Complementary, Over the Counter (OTC) and Prescription must be entered on the Australian Register of Therapeutic Goods (ARTG) before supply may commence.

ADVANTAGE MPC can assist you to quickly establish the specific requirements for your product. We can provide a complete application service, ensuring all your data meets the relevant guidelines; lodge applications; and liaise with the TGA throughout the evaluation process, allowing you to focus on your core business.

Australian Manufacturers must be appropriately licensed.  Overseas manufacturers must meet equivalent standards.  The TGA will not accept your application if your overseas manufacturer does not meet Australia's Standard of Good Manufacturing Practice.  If you consider your manufacturer meets this standard, please email a copy of your GMP Certificate and we can quickly tell you if it satisfies TGA requirements. If your manufacturer cannot provide suitable evidence of GMP, the products can not be supplied in Australia.

Other requirements include:

• All products to be entered on the ARTG must have a Sponsor in Australia.
• The labels must be in English and meet Australia's standard for medicines labelling.
•  For prescription medicines, data must be available for evaluation which satisfies the Australian Regulatory Guidelines for Prescription Medicines (ARGPM). Australia also requires data to be in Common Technical Document (CTD) format.
• For over the counter (OTC) medicines, data must be available for evaluation which satisfies the Australian Regulatory Guidelines for OTC medicines (ARGOM).
• Complementary medicines may be registered (higher risk) or listed (lower risk).
• • For registered complementary medicines data must be available for evaluation which satisfies the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) .
  • Listed complementary medicines are entered directly on the ARTG using the online Electronic Lodgement Facility (ELF). All ingredients must be eligible for listed medicines and labels must be in English and meet Australia's standards.

New Zealand Requirements

All prescription and OTC medicines require prior approval from MEDSAFE before supply in New Zealand.    The requiremenrts are outlined in New Zealand Regulatory Guideline for Medicines.  Applications for new medicines and related products and for notifying changes can be prepared and lodged with MEDSAFE.

New Zealand is in a time of transition for complementary medicines currently regulated as dietary supplements without claims. The Dietary Supplements Notification Database is being used to collect information about complementary medicines on the New Zealand market prior to the establishment of a trans-Tasman regulatory scheme. The information will be used to issue interim product licences when the scheme commences.

Getting Started...

To get started, ADVANTAGE MPC needs a list of the formulations you wish to import. You can use our Formulations Form to provide details of the product. Please complete and email or fax us the ADVANTAGE MPC Formulations Form and complete the Free Online Consultation Form.