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 TGA-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 TGA-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: