Information updates

Important change to TGA Authorised Prescriber scheme

19 October 2020

The Therapeutic Goods Administration (TGA) has streamlined the Authorised Prescriber application process to access allergens for skin prick and intradermal testing, by removing the requirement for Human Research Ethics Committee (HREC) approval or specialist college endorsement. 

This change to the TGA Authorised Prescriber scheme will simplify access to skin testing reagents for ASCIA members, which was raised as one of ten main issues in the ASCIA Submission to the Parliamentary Inquiry on Allergies and Anaphylaxis. Access to skin testing reagents has been a major issue for ASCIA members since 2008, so this change is welcome news. 

The changes to the TGA Authorised Prescriber scheme (effective October 2020) will streamline the application process for medicines considered to have an established history of use in Australia.  The TGA list of ‘medicines’ with an established history of use includes:

  • Allergens for skin prick testing (SPT), including control solutions, for confirmation of suspected allergic reactions – TGA code AP3.
  • Allergens for intradermal testing (IDT), including control solutions, for confirmation of suspected allergic reactions – TGA code AP2.

The changes include removal of the requirement for HREC approval or specialist college endorsement to be submitted to the TGA in circumstances where a medical practitioner is applying to become an Authorised Prescriber of medicines with an established history of use, as specified in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990

A printable (pdf) version of the list is on the TGA website list of medicines with an established history of use and is also available here  pdfTGA-list-of-medicines-with-an-established-history-of-use-2020-October112.58 KB

The application process has now been updated for use under the new arrangements when renewal applications are due. The updated application form is available on the TGA website www.tga.gov.au/form/authorised-prescribers#apf and is also available here docxTGA-authorised-prescriber-scheme-application-form-201008144.64 KB

The above information and a list of allergen suppliers, is on the ASCIA website www.allergy.org.au/members/ascia-member-access-to-spt-reagents

To view the ASCIA Submission to the Parliamentary Inquiry on Allergies and Anaphylaxis and the Inquiry Report recommendations go to www.allergy.org.au/ascia-reports#s1 or click on the pdfs below:

pdfASCIA Submission Parliamentary Inquiry 

pdfWalking the allergy tightrope 

 

Mod ASCIA Member
Donate to AIFA
go to NAS website
Member Login
ASCIA Update

Information for the community about allergic diseases, immunodeficiencies and other immune diseases.
See latest edition here...
Join our mailing list:

About ASCIA

ASCIA is the peak professional body of clinical immunology and allergy in Australia and New Zealand
ASCIA promotes and advances the study and knowledge of allergy and other immune diseases

Quick Links

About ASCIA

ASCIA is a registered trademark of the Australasian Society of Clinical Immunology and Allergy. All content is subject to copyright for the Australasian Society of Clinical Immunology and Allergy. Read more...

The content for the website is developed and approved by ASCIA Committee and ASCIA Working Party Members. Read more...

Disclaimer I Privacy

The ASCIA website is intended for use by ASCIA members, health professionals and the general public. The content provided is for education, communication and information purposes only and is not intended to replace or constitute medical advice or treatments. Read more...

ASCIA respects your privacy. Read our privacy policy here...

Sponsors | Advertising

ASCIA does not endorse products from sponsoring organisations, nor is it influenced by sponsoring organisations with regard to the content of education programs and websites. 

The ASCIA website does not accept advertising. Any link to a third-party website does not imply any endorsement by ASCIA.

Accreditiation

healthdirect

This website is certified by Health On the Net Foundation. Click to verify. This site complies with the HONcode standard for trustworthy health information: verify here.