Instructions for completing a statutory declaration regarding 38(1)(g)

Statutory declaration information

In granting a licence under section 38 of the Therapeutic Goods Act 1989 (the Act), the Secretary must consider the criteria specified in subparagraphs 38(1)(e)-(h) of the Act. One of the things that the Secretary or delegate must consider is whether the applicant, or certain persons associated with the applicant, during a specified period, have been convicted of an offence against the Act or a corresponding State law. The Secretary or delegate within the TGA may refuse to grant a manufacturing licence if any of the criteria specified in paragraphs 38(1)(e) - (h) of the Act apply to a relevant person.

All applicants for a manufacturing licence are expected to self-assess whether the criteria in subparagraphs 38(1)(g)(i) - (x) of the Act apply to them or certain other persons associated with them, including a body corporate. This self-assessment can be undertaken by submitting a Commonwealth statutory declaration to the TGA.

Applicants seeking to transfer their licence are also expected to certify that the criteria in subparagraph 38(1)(g)(i) - (x) of the Act do not apply to them or certain persons associated with them. Again, this can be done by submitting a Commonwealth statutory declaration to the TGA.

The provisions of the Act can be viewed on the Federal Register of Legislation at Therapeutic Goods Act 1989. Further information regarding the Act is available on the TGA website.

Instructions for submitting a Commonwealth statutory declaration are outlined below.

Steps to submitting a valid Commonwealth statutory declaration form

1. Read and understand the relevant provisions

• Carefully review the legal requirements, specifically the subparagraphs from 38(1)(g)(i) to 38(1)(g)(x) of the Act.
• Make any necessary enquiries to ensure you can answer all matters required for declaration.

2. Complete a Commonwealth statutory declaration form

• For the statutory declaration to be valid, it must:
  1. be in the approved online Commonwealth statutory declaration form, available at Commonwealth statutory declaration form - to be made with a witness | Attorney-General's Department.
  2. be completed in the presence of an authorised witness. Additional guidance for witnesses is available at Information for witnesses | Attorney-General's Department.
• In section 2 that says "Set out matter declared to in numbered paragraphs (required)" the applicant should include:
  • the full name of the person making the declaration;
  • their position of the person making the declaration within the company making the application;
  • the name of the company making the application; and
  • the address of the company making the application.
  • the declaration should include all the requirements outlined in section 38(1)(g)(i) through 38(1)(g)(x) of the Act. This can be done by copying the information below into the declaration
• The information in the statutory declaration should declare the following:
  none of the following people:
  1. the applicant for the licence to manufacture therapeutic goods (the Applicant);
  2. a person who makes, or participates in making, decisions that affect the whole, or a substantial part, of the Applicant’s affairs;
  3. if the applicant is a body corporate - a major interest holder of the body corporate;
     1. has, within the 10 years immediately before this application:
  4. been convicted of an offence against the Act or a corresponding State law; or
  5. been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
  6. been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of the Act or a corresponding State law; or
  7. been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
  8. breached a condition of a manufacturing licence; or
  9. had a manufacturing licence suspended or revoked; or
  10. been a manager, or major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix), noted above, applied in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate.

3. Submit the completed Commonwealth statutory form

• Please send the completed Commonwealth statutory declaration form by email to GMP@health.gov.au. Please ensure that your email identifies the tracking number of the associated manufacturing licence application. If email delivery is not an available option, then the completed statutory declaration may then be submitted by fax to 02 6232 8426, or by post to the following address:
  
  The Licensing, Certification and Engagement Section
  Manufacturing Quality Branch
  PO Box 100
  Therapeutic Goods Administration
  Woden ACT 2606

Note the declarant must:

• if the applicant for a manufacturing licence is an individual, be that individual; or
• if the applicant for a manufacturing licence is a body corporate, hold a senior position in that body corporate (e.g. Chief Executive Officer or Managing Director) and be authorised to make the certification on behalf of the body corporate.

Where an application for a manufacturing Licence has already been submitted through the TGA’s eBusiness, Manufacturing Information System (MIS), applicants should also include, in their email or postal application, the relevant MIS application Tracking Number for that application.

Further information

Under paragraph 37(2)(a) of the Act the Secretary, or delegate, may, by written notice and within a reasonable period of time, require an applicant for a manufacturing Licence to give the Secretary, or delegate, further information concerning the application.

Special circumstances

Under subsection 38(2) of the Act the Secretary, or delegate, may consider additional information submitted by an applicant who is unable to satisfy the Secretary that they meet the matters in paragraph 38(1)(e)-(h) of the Act. The Secretary, or delegate, will consider this information and may decide to grant, or refuse to grant, a manufacturing licence or licence transfer depending upon the circumstances.

Providing a sufficient statutory declaration

Your statutory declaration might not be considered sufficient as a self-assessment if it:

• is not used;
• is incomplete;
• is unclear or ambiguous;
• has been submitted more than a month since the date of its signing.

Privacy information

For general privacy information, go to the TGA privacy web page.

Personal information in applications relating to manufacturing licences:

• The TGA collects personal information in applications for Australian manufacturing licences, and associated applications such as to vary existing manufacturing licences.
• The personal information is used to maintain a record of manufacturing licence applications, to consider applications, and to contact applicants about their application.
• Personal information provided in applications may also be used to contact sponsors or manufacturers of goods in the Register where there is a need to do so - for example, in the event of a safety, quality or efficacy issue concerning the manufacture of certain goods, or to administer fees and payments relating to the licence.
• Personal information relating to holders of licences to manufacture therapeutic goods may be disclosed where authorised or required by an Australian law, Court or Tribunal order; or with the consent of the person the information is about.

Note: A "major interest holder" of a body corporate means a person who;

1. is in a position to cast, or control the casting of, more than one-fifth of the maximum number of votes that might be cast at a general meeting of the body corporate; or

2. holds more than one-fifth of the issued share capital of the body corporate (excluding any part of that issued share capital that carries no right to participate beyond a specified amount in a distribution of either profits or capital).

Note: A holder of a manufacturing Licence on or after 1 December 2009 may be asked by the TGA to complete (by self-assessment) a statutory declaration to be used by the Secretary, or delegate, in deciding whether to revoke or suspend a manufacturing Licence, if the Secretary, or delegate, believes this is necessary.