Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41AB

  (1)   If:

  (a)   a person is the holder of a licence; and

  (b)   the person has carried out, or is carrying out, one or more steps in the manufacture of therapeutic goods;

the Secretary may, by written notice given to the person, require the person to:

  (c)   give the Secretary information, or produce to the Secretary documents, relating to one or more of the following:

  (i)   the therapeutic goods;

  (ii)   if the therapeutic goods consist of a mixture of ingredients--those ingredients;

  (iii)   if the therapeutic goods consist of a mixture of ingredients--the suppliers of those ingredients;

  (iv)   if the therapeutic goods consist of a combination of component parts--those component parts;

  (v)   if the therapeutic goods consist of a combination of component parts--the suppliers of those component parts;

  (vi)   the containers or packages used, or proposed to be used, to contain the therapeutic goods;

  (vii)   the batch numbers of the therapeutic goods;

  (viii)   the expiry dates of the therapeutic goods;

  (ix)   the distribution of the therapeutic goods;

  (x)   the conformity of the therapeutic goods to a standard applicable to the goods;

  (xi)   the step or steps that the person has carried out, or is carrying out, in the manufacture of the therapeutic goods;

  (xii)   the premises used to carry out one or more steps in the manufacture of the therapeutic goods;

  (xiii)   the observance of the manufacturing principles;

  (xiv)   the names, qualifications and experience of individuals who have control of any of the steps that have been carried out, or are being carried out, in the manufacture of the therapeutic goods;

  (xv)   the measures for quality assurance and quality control employed in the taking of any of the steps that have been carried out, or are being carried out, in the manufacture of the therapeutic goods;

  (xvi)   compliance with the conditions of the licence;

  (xvii)   whether there are grounds for revoking or suspending the licence;

  (xviii)   any other matter that is prescribed by the regulations and that relates to the manufacture of the therapeutic goods; and

  (d)   do so:

  (i)   within such reasonable time as is specified in the notice; and

  (ii)   in such form as is specified in the notice.

  (2)   The time specified in the notice must not be shorter than 14 days after the notice is given.

  (3)   The rule in subsection   (2) does not apply if the Secretary is satisfied that, because of circumstances of urgency, the time specified in the notice should be shorter than 14 days after the notice is given.

  (4)   An approval of a form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements:

  (a)   on a specified kind of data processing device; or

  (b)   by way of a specified kind of electronic transmission.