澳洲TGA人用药品报批指南.pdf

Access to Unapproved Therapeutic Goods
- Authorised Prescribers
October 2004
INDEX
These guidelines 4
Introduction 6
The legal basis for supply of unapproved therapeutic goods 6
Promotion of unapproved therapeutic goods 8
Release of information 8
Basic principles governing the supply of unapproved products using the
Authorised Prescriber mechanism 10
Patient rights 10
Responsibilities of the prescriber 10
Responsibilities of the TGA 11
Rights and responsibilities of the sponsoring company (supplier) 11
Conditions of Authorisation 12
Other 12
The TGA's attitude toward existing Section 19(5)/41HC Authorisations when
another product is registered for treatment of the specific condition 13
How to become an Authorised Prescriber 14
Who can become an Authorised Prescriber? 14
Requesting an authorisation from TGA - the overall approach 14
The criteria used by delegates in deciding whether to give Authorisation 14
How TGA balances the criteria 17
The role of the ethics committee 19
Information required by the ethics committee when considering
endorsement of a medical practitioner as an Authorised Prescriber 19
Conditions may be imposed on the endorsement by an ethics committee 19
An ethics committee can withdraw its endorsement