Assurances to accompany a L(A)1 application
Completing this form
This form must be completed and submitted for all L(A)1 applications in Module 1.5.7 of the application. Completing this form provides the assurances required to accompany a L(A)1 application.
- Enter the required administrative details in Section 1
- Select 'Yes' to provide the assurance or 'Not applicable' where appropriate (Do not select 'Not applicable' unless this option is available in the form).
- All assurances in this form must be provided. If you cannot provide all of the assurances, do not submit a L(A)1 application (as this is not the correct application level).
- Have the form signed by a person authorised to conduct business on behalf of the applicant. This person must be listed on the TGA Business Services client database, and may be a company employee or an agent.
- Giving information that is false or misleading in a material particular is an offence under the Therapeutic Goods Act 1989 (section 22A) and can give rise to civil penalties under the Act (section 22B).
- Under subsection 26AD(1) of the Act, an application for the listing of a medicine lapses if:
- it contains information that is inaccurate or misleading in a material particular
- information that is inaccurate or misleading in a material particular is given to the TGA in connection with the application, including information given for the purposes of section 31 of the Act.
- Following approval, medicines found not to comply with standard and specific conditions of listing could be subject to regulatory action.
This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.