澳洲tga人用药品报批指南.docVIP

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 TGAs attitude toward existing Section 19(5)/41HC