Forms for sponsors of prescription medicines

Prescription medicines forms

• Prescription medicine registration form & guide
  <http://www.tga.gov.au/docs/html/pmrvform.htm>
  Use to apply for registration or to vary the conditions of registration for prescription medicines in Australia
• Supply of information for the creation of a Provisional ARTG Record (PAR)
  <http://www.tga.gov.au/docs/html/forms/parform.htm>
  Use to apply to the Drug Safety and Evaluation Branch for the creation of a provisional ARTG record
• Summary of a bioavailability or bioequivalence study
  <http://www.tga.gov.au/docs/html/forms/pmbiosum.htm>
  Use to submit a summary of a bioavailability or bioequivalence study
• Notification of proposal to submit supplementary data and submission of supplementary data
  <http://www.tga.gov.au/docs/html/forms/suppdata.htm>
  Use to notify the TGA of a proposal to submit supplementary data and to submit supplementary data
• Report of the manufacture of exempt therapeutic goods
  <http://www.tga.gov.au/docs/html/forms/exempttg.htm>
  Used by sponsors of exempt therapeutic goods to inform the TGA of the details of the supply of such goods on a quarterly basis
• Therapeutic goods and use of human embryos or human embryonic stem cells or material derived therefrom
  <http://www.tga.gov.au/docs/html/forms/stemcell.htm>
  Use this form for products that are manufactured using a human embryo or a human embryonic stem cell, or any material sourced from a human embryo or human embryonic stem cell
• Justification for a particular route of evaluation
  <http://www.tga.gov.au/docs/html/forms/justsch10.htm>
  To be completed 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
• Notification of a proprietary ingredient
  <http://www.tga.gov.au/docs/html/forms/notifpi.htm>
  Allows proprietary ingredient formulations to be entered onto the ARTG

Related (general) forms

• Client details form
  <http://www.tga.gov.au/docs/html/forms/clientdt.htm>
  To be completed by or for each client involved with the supply of the therapeutic goods in Australia for which the TGA requires address details
• Australia-US Free Trade Agreement certificates
  <http://www.tga.gov.au/international/usfta.htm>
  The Australia-US Free Trade Agreement came into force on 1 January 2005
• Authorisation to cancel a product from the Australian Register of Therapeutic Goods
  <http://www.tga.gov.au/docs/html/forms/artg-cancel.htm>
  Use to request cancellation of the registration/listing/inclusion of medicines and/or devices on the ARTG
• Request to transfer the sponsorship of an ARTG entry - relinquishing company
  <http://www.tga.gov.au/meds/tsfrelinqco.htm>
  Used by the relinquishing company to request to transfer the sponsorship of an ARTG entry
• Request to transfer the sponsorship of an ARTG entry - accepting company
  <http://www.tga.gov.au/meds/tsfacceptco.htm>
  Used by the accepting company to request to transfer the sponsorship of an ARTG entry

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