Product information

2 June 2011

If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.

Restricted medicine specification 2011

The Restricted Medicine Specification 2011 lists the medicines or classes of medicine that are to be 'restricted medicines' for which a draft PI (product information) document is required as part of the submission dossier.

Approval of the form

Approval of the form, under subsection 7D(1) of the Therapeutic Goods Act 1989, for providing product information for a restricted medicine or other medicine in relation to which the secretary requires product information to be provided.

Form for providing product information

As a part of an application to register a restricted medicine, a draft product information document must be lodged in a form approved by the secretary under section 7D of the Therapeutic Goods Act 1989. This form is specified in Form for providing product information for a restricted medicine or other medicine in relation to which the secretary requires product information to be provided.

PI questions and answers

The TGA has developed a question and answer page to assist sponsors with the PI changes.