These forms are for the OTC medicines industry. For a complete list of forms, see: Forms

A C J N P R T

A

• Analytical validation summary form
  Use this form to summarise supporting validation data for each assay
• Assurances to accompany an OTC new medicine N1 application
  This form is to be submitted as part of an OTC New Medicine N1 application
• Assurances to accompany an OTC new medicine N2 application
  This form is to be submitted as part of an OTC New Medicine N2 application
• Australia-United States Free Trade Agreement
  The Australia-US Free Trade Agreement (the Agreement) came into force on 1 January 2005

C

• Consent to supply goods that do not conform with subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines - section 14/14A
• Consent to import, supply or export goods that do not comply with standards - section 14/14A

J

• Justification for a particular route of evaluation
  Use when an applicant wishes to have their product or substance evaluated by an area of the TGA other than as specified in Schedule 10 to the Therapeutic Goods Regulations

N

• Notification of a change in sponsorship
  Used to notify a change in sponsorship of an ARTG entry
• Notification of a new proprietary ingredient
  Use to supply TGA with information about a proprietary ingredient

P

• Proposal to amend the Required Advisory Statements for Medicine Labels (RASML)
  Use this form to propose an amendment to the Required Advisory Statements for Medicine Labels (RASML)
• Proposed Australian Approved Name (AAN) application form
  Use this form to apply for an Australian Approved Name

R

• Request to cancel an entry/entries from the Australian Register of Therapeutic Goods (ARTG)
  Use to request cancellation of the registration/listing/inclusion of medicines and/or devices on the ARTG

T

• TGA Business Services forms
  Forms for sponsors, agents and manufacturers to apply for access to TGA Business Services