Consultation: Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS)

15 February 2017

This consultation closes on 29 March 2017.

Invitation to comment

The TGA is seeking comments from interested parties on the proposed changes to the Special Access Scheme (SAS) and the Authorised Prescriber Scheme.

Consultation documents

How to access a pdf or Word document

Timetable

Documents released for consultation on Wednesday, 15 February 2017.

Interested parties should respond by close of business Wednesday, 29 March 2017.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

The TGA is proposing to implement changes that will improve access to unapproved therapeutic goods. The changes will apply to the Special Access Scheme and the Authorised Prescriber Scheme.

The attached consultation document describes the changes proposed and poses questions where feedback is being sought.

Background

The MMDR Review made three recommendations to improve access to unapproved therapeutic goods through changes to the SAS and Authorised Prescriber Schemes. These are outlined in recommendations 24, 25 and 26 of the document Review of Medicines and Medical Devices Regulation - Recommendations.

The recommendations made are to decrease duplication of work undertaken and to streamline access to unapproved therapeutic goods which are considered to have an established history of use.

Content of submissions

Submissions may address any, or all, of the proposals included in the Changes to Accessing Unapproved Therapeutic Goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS) consultation document.

How to submit

Complete the online Consultation submission form, upload your submission in either pdf or word format and click submit.

Consultation submission form

Alternatively, hardcopy submissions with a printed coversheet may be mailed to:

Reforms and Operations Section
Pharmacovigilance and Special Access Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

How to access a Word document

Enquiries

Any questions relating to submissions should be directed to the Reforms and Operations Section of the Pharmacovigilance and Special Access Branch by email to or by telephone to 02 6232 8063.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • Seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.