Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 38B

  (1)   This section applies if a licence (the old licence ):

  (a)   either:

  (i)   was in force under this Part   immediately before the commencement of this section; or

  (ii)   was suspended under this Part   immediately before that commencement; and

  (b)   related to premises that comprise 2 or more sites (the old sites ).

  (2)   As soon as practicable after the commencement of this section, the Secretary must:

  (a)   by writing, revoke the old licence; and

  (b)   on the day that the Secretary revokes the old licence, grant new licences (each of which is a new licence ) to the holder of the old licence which, when considered together, cover the old sites.

The Secretary must give the holder written notice of the revocation and grant.

Note:   Subsections   (5) and (6) deal with when each new licence commences and when the old licence ends.

Guidelines

  (3)   The Secretary must have regard to the guidelines under section   38A in granting licences under this section.

Application of this Part

  (4)   Subject to this section, subsections   38(2B) and (4) and sections   39 to 41A apply to a new licence in the same way as they apply to a licence granted under section   38.

Note:   This means, for example, that:

(a)   the Secretary must give a manufacturing site authorisation under subsection   38(2B) in relation to each manufacturing site covered by a new licence; and

(b)   the Secretary may impose conditions on a new licence under subsection   40(1) and the statutory conditions under subsection   40(4) will apply to a new licence; and

(c)   the Secretary may revoke or suspend a new licence under section   41.

Commencement of new licence

  (5)   The day specified under subsection   39(1) for the commencement of each new licence granted to the holder of the old licence must be the day (the transition day ) after the day each new licence is granted.

Note:   Subsection   (7) deals with suspending a new licence from the transition day.

When revocation of old licence takes effect

  (6)   The revocation of the holder's old licence takes effect immediately before the start of the transition day.

Suspension of new licence

  (7)   If:

  (a)   subparagraph   (1)(a)(ii) applies in relation to an old licence; and

  (b)   the period of suspension of the old licence is due to end at the end of a day (the relevant day ) after the transition day;

the Secretary may, on the day that the Secretary grants a new licence to the holder of the old licence and by notice in writing given to the holder, suspend the new licence for a period starting on the transition day and ending at the end of the relevant day.

  (8)   Subsection   41(2) does not apply in relation to a suspension under subsection   (7) of this section. However, subsections   41(4) to (6) do apply in relation to the suspension.

  (9)   To avoid doubt, subsection   (7) does not prevent subsection   41(1) from applying in relation to a new licence.

Licence charges

  (10)   Subsection   4(2) of the Therapeutic Goods (Charges) Act 1989 does not apply in relation to a new licence for the financial year in which the new licence is granted.

No review of revocation of old licence

  (11)   The revocation of the old licence is taken not to be an initial decision for the purposes of section   60.