Post Market Activity

• Advertising

Advertisements for therapeutic goods in Australia are subject to the requirements of the Therapeutic Goods Act and Regulations, the Trade Practices Act and other relevant laws. Advertisements directed to consumers must also comply with the Therapeutic Goods Advertising Code.   Advertising in print media, and on Television and Radio requires an advertising clearance number showing approval by the appropriate Advertising Services Manager of the relevant industry associations, before the advertising may take place.  Advantage MPC can assist you apply for Advertising approvals, responding to advertising complaints, ensuring that your Website meets the Advertising Code and regulations.  

• Complaints handling & Problem Reports

Advantage MPC can advise and assist you with your complaints handling procedures.  We can train staff  help with understanding of what, when & how reports need to be forwarded to the  TGA.    

• Recalls

The Uniform Recall Procedure for Therapeutic Goods (URPTG) defines the action to be taken by health authorities and sponsors when therapeutic goods for use in humans, are to be removed from supply or use, or subject to corrective action for reasons relating to their quality, safety or efficacy.  Advantage MPC can advise you or manage this process for you.

• Product Changes

Advantage MPC can advise and assist you with what changes may be implemented without prior approval and the changes that must be approved by the TGA or Medsafe prior to implementation.

• TGA Fees and Charges

Advantage MPC can assist with Low Turnover claims that allow minimisation of the Annual Charges for slow moving products or service lines that you carry in your inventory.

• Staff training

Advantage MPC can help with training of new staff with regulatory responsibilities.

Please complete and email or fax us the ADVANTAGE MPC  Free Online Consultation Form.