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Variation applications to the TGA or Medsafe

Existing products need to be changed from time to time and this usually requires an application to the TGA or Medsafe. Changes may be simple (e.g. only requiring notification to the agency) or complex (requiring the approval of the agency).

In either case you need to be sure that the change is accordance with all relevant legislation and guidelines. Sometimes a change in one area can reveal problems in another that can be difficult to resolve.

We can either help you to prepare an application or prepare and lodge it on your behalf. Our expertise can help you deal with difficult issues quickly and efficiently.

Contact us for more information.



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Archer Emery & Associates is a member of the
Australian Self-Medication Industry Inc
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