Tga Sas Portal

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Updated: April 12, 2022

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Tga.gov.au

FAQs

1

What is SAS medication?

The Special Access Scheme (SAS) allows certain health practitioners to access therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) for a single patient.
2

What is a SAS form?

The FORMS procedure produces labels for envelopes, mailing labels, external tape labels, file cards, and any other printer forms that have a regular pattern. For each observation in the input SAS data set, PROC FORMS prints data in a rectangular block called a form unit.
3

How do I get TGA approval?

Here are the 6 steps involved
  1. Check if your product is a therapeutic good.
  2. Decide whether you want to have it approved in your name to supply it in Australia.
  3. Find out what type of therapeutic good the product is and review the relevant guidelines.
  4. Understand the legal requirements for your product to be approved.
4

What does it mean to be TGA approved?

The 'TGA assessed' claim (symbol and/or statement) shows that the Therapeutic Goods Administration (TGA) has assessed the medicine's indications (conditions the medicine says it will treat) and found they are supported by scientific evidence. This is also called an 'efficacy' assessment.

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