(a) a person has made an application to carry out steps in the manufacture of therapeutic goods at one or more manufacturing sites; and
(b) the prescribed application fee has been paid; and
(c) any applicable prescribed inspection fees have been paid; and
(d) the applicant has complied with any requirements made by the Secretary under subsection 37(2) in relation to the application;
the Secretary must grant the applicant a licence covering one or more manufacturing sites specified in the licence unless the Secretary is satisfied that:
(e) the applicant will be unable to comply with the manufacturing principles; or
(f) one or more of the manufacturing sites identified in the application are not satisfactory for the manufacture of the goods; or
(fa) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)--the manufacture in Australia of the goods would contravene one or more of those prohibitions; or
(fb) if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions--the manufacture in Australia of the goods would contravene one or more of those conditions; or
(g) at least one of the following persons:
(i) the applicant;
(ii) a person (a manager ) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant's affairs;
(iii) if the applicant is a body corporate--a major interest holder of the body corporate;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against this Act or a corresponding State law; or
(v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or
(vii) 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
(viii) breached a condition of a manufacturing licence; or
(ix) had a manufacturing licence suspended or revoked; or
(x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies 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; or
(h) any other circumstances prescribed by the regulations for the purposes of this paragraph exist.
(1A) A reference in paragraph (1)(g) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914 ; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(1AA) Paragraph (1)(g) does not limit paragraph (1)(h).
(1B) In paragraph (1)(g):
"manufacturing licence" means:
(a) a licence granted under this Part; or
(b) a licence, granted under a law of a State or Territory relating to therapeutic goods, relating to manufacturing therapeutic goods.
Special circumstances justifying grant of licence
(2) Notwithstanding paragraph (1)(g), the Secretary may grant a licence to an applicant who, apart from this subsection, could not be granted a licence because of that paragraph if, in the opinion of the Secretary, special circumstances make it appropriate to do so.
(2A) The Secretary must have regard to the guidelines under section 38A in granting licences under this section.
What the licence authorises
(2B) For each manufacturing site covered by a licence, the Secretary must authorise, in the licence, the holder of the licence to carry out specified steps in the manufacture of specified therapeutic goods at that manufacturing site.
Note 1: For specification by class, see subsection 33(3AB) of the Acts Interpretation Act 1901 .
Note 2: Sections 40A and 40B deal with variation of authorisations.
Notice of decision
(3) Where the Secretary grants or refuses to grant a licence to an applicant, the Secretary must:
(a) give the applicant written notice of the decision; and
(b) in the case of a refusal--include in the notice the reasons for the refusal.
(4) Where the Secretary grants a licence, the Secretary must cause particulars of the decision to be published in the Gazette or on the Department's website as soon as is practicable after the decision is made.