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Approval of forms for applications under section 23 of the Therapeutic Goods Act 1989 for registration of therapeutic goods

9 March 2018

I, Rochelle Christian, Assistant Secretary, Scientific Evaluation Branch in the Therapeutic Goods Administration and delegate under subsection 57(1) of the Therapeutic Goods Act 1989 (the Act) of the Secretary of the Department of Health, for the purpose of subsection 23(1) of the Act hereby:

  1. REVOKE the approval of Peter Bird dated 1 May 2014 of the forms for applications for the registration of therapeutic goods for the purpose of subsection 23(1) from the date of this approval.
  2. APPROVE the form Module 1.2.1: Application form to register or vary the registration of prescription medicines, dated January 2018 to be the form for the purpose of applications referred to in regulation 16C of the Therapeutic Goods Regulations 1990 (the Regulations) for an additional trade name for a medicine of a kind specified in Part 1 of Schedule 10 of the Regulations registered to the same sponsor, to the extent that it applies in relation to such applications.
  3. APPROVE the following to be the forms for the purpose of applications for or in relation to the registration of a medicine referred to in regulation 16C of the Regulations that is a product of a kind specified in Part 1 of Schedule 10 of the Regulations (other than applications referred to in paragraph 2):
    1. the Pre-submission planning form - Category 1 and Category 2 applications, dated April 2014 and described as Version 2.1; and
    2. for such applications to register a new chemical entity or a new generic medicine – the Prescription Medicines (PREMIER) Electronic Lodgement facility, accessible via the 'Prescription Medicines' link on the TGA eBusiness Services website (http://www.ebs.tga.gov.au); and
    3. for such applications other than applications to register a new chemical entity or a new generic medicine - the form Module 1.2.1: Application form to register or vary the registration of prescription medicines, dated January 2018, to the extent that it applies in relation to such applications.
  4. SPECIFY the following office of the Department as the office at which such applications must be delivered:
    • Therapeutic Goods Administration
      PO Box 100
      Woden ACT 2606
      Australia
    • OR
    • Therapeutic Goods Administration
      136 Narrabundah Lane
      Symonston ACT 2609

Note 1: The reference to applications referred to in regulation 16C of the Regulations means that only applications to which the 255 working day or 175 working day or 120 working day completion time for evaluation applies are covered by this determination i.e. Category 1 and Comparable Overseas Regulator (COR) report-based applications.

Note 2: The reference to Part 1 of Schedule 10 of the Regulations indicates that this form is not relevant to applications for registration made under section 23 of the Act for over-the-counter medicines or registered complementary medicines.

Rochelle Christian
Delegate of the Secretary

2 March 2018

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