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TGA Change Applications – Variations and Notifications

Making changes to products can be a simple process that only requires you to notify the Therapeutic Goods Administration (TGA), or it can be a complex one that requires a full assessment and approval by the agency. What’s more, sometimes a change in one area can mean changes are also required in another that take…


TGA/Medsafe Medicine Applications

When you’re dealing with the Therapeutic Goods Administration (TGA), even having a crack regulatory team is no guarantee of success. Up to 20% of OTC applications alone are withdrawn or rejected. Many more are delayed and suffer cost blowouts because they didn’t meet the TGA’s requirements. Without someone on your team who knows the system…


New Product Applications

The type of application you make depends on the type of product you have. Some products need to be ‘registered’ and undergo a full evaluation, while others fall within the ‘listed’ classification and can be self-assessed. Knowing the difference can save you a lot of time and money. We can advise you on which application…