Approval of form in which information sufficient for determination of applications made under section 23 of the Therapeutic Goods Act 1989 for the registration of therapeutic goods

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 paragraph 23(2)(b) of the Act hereby:

1. REVOKE the approval of Peter Bird dated 1 May 2014 of the form in which information must be delivered for an application for or in relation to the registration of medicines listed in Part 1 of Schedule 10 of the Therapeutic Goods Regulations 1990 (the Regulations) for the purposes of paragraph 23(2)(b) from the date of this determination;
2. APPROVE, for the purposes of paragraph 23(2)(b) of the Act, for applications referred to in regulation 16C of 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, the following information, being such information as will allow the determination by the Secretary of an application for or in relation to the registration of medicines of that kind:
   1. the application in the form approved by the Secretary's delegate under the instrument Approval of forms for applications under section 23 of the Therapeutic Goods Act 1989 for registration of therapeutic goods for applications of that kind completed in accordance with the relevant instructions, and
   2. CTD Module 1: Administrative information and prescribing information for Australia dated February 2018 and described as Version 4.0, completed in accordance with relevant instructions; and
   3. any other information specified in the document Mandatory requirements for an effective application, dated February 2018 and described as Version 4.0, being required to be provided with an application of that kind in order for the application to be effective;
3. APPROVE, for the purposes of paragraph 23(2)(b) of the Act, for 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 or of the kind in relation to which the Secretary has made another determination under paragraph 23(2)(b) of the Act), the following information, being such information as will allow the determination by the Secretary of the application:
   1. for all such applications where a Pre-submission planning form has not been provided to the Secretary in relation to the application - a Pre-submission planning form, approved by the Secretary's delegate under the instrument Approval of form for applications under section 23 of the Therapeutic Goods Act 1989 for registration of therapeutic goods completed in accordance with relevant instructions (including any documentation required to be provided with that form), and
   2. where a Pre-submission planning form, has been provided to the Secretary in relation to the application:
      1. for such applications that are 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);
      2. for such applications other than applications to register a new chemical entity or a new generic medicine - the form Module 1.2.1: Application for the Registration, or to vary the Conditions of Registration, of Prescription Medicines dated January 2018, to the extent that it applies in relation to such applications, being the form approved by the Secretary's delegate under the instrument Approval of form for application under subsection 23 of the Therapeutic Goods Act 1989 for registration of therapeutic goods completed in accordance with relevant instructions (including any documentation required to be provided with that form);
      3. for all application covered by this paragraph, the following documents:
         • for applications received by the TGA from the date of this determination - CTD Module 1: Administrative information and prescribing information for Australia dated February 2018 and described as Version 4.0, completed in accordance with relevant instructions;
         • Module 2: being overviews, written summaries and tabulated summaries of the data contained in the Modules 3, 4 and 5 as described below completed in accordance with relevant instructions;
         • Module 3: ICH M4Q Common Technical Document for the Registration Of Pharmaceuticals For Human Use - Quality (CPMP/ICH/2887/99 Rev 1 Quality), completed, to the extent that it is applicable to a medicine of the nature and type of the medicine the subject of the application, in accordance with relevant instructions;
         • Module 4: ICH M4S Common Technical Document for the Registration of Pharmaceuticals for Human Use - Safety (CPMP/ICH/2887/99 Rev 1 Safety) completed, to the extent that it is applicable to a medicine of the nature and type of the medicine the subject of the application, in accordance with relevant instructions; and
         • Module 5: ICH M4E Common Technical Document for the Registration of Pharmaceuticals for Human Use - Efficacy (CPMP/ICH/2887/99 Rev 1 Efficacy), completed, to the extent that it is applicable to a medicine of the nature and type of the medicine the subject of the application, in accordance with relevant instructions; and
4. any other information specified in the document Mandatory requirements for an effective application, dated February 2018 and described as Version 4.0, being required to be provided with an application of that kind in order for the application to be effective.

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 ie 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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