Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This section is made for the purposes of subsection 99AEKF(1) of the Act.
Prescribed information
(2) The responsible person for a brand of a pharmaceutical item must provide the following information in relation to the quantity of the brand of pharmaceutical item kept in stock in Australia:
(a) the start and end dates of the period to which the information relates;
(b) the name of the brand;
(c) the name of the responsible person;
(d) the name of the drug in the pharmaceutical item;
(e) the form of the drug, including its strength;
(f) the manner of administration of the form of the drug;
(g) the number or quantity of units in a pack (the number of tablets in a pack, for example);
(h) the number of packs held in stock at the end of each month in the period.
Prescribed person
(3) The responsible person must provide the information to the same person to whom the responsible person must give information under subsection 85(6).
Prescribed manner and form
(4) The responsible person must provide the information in a form approved, in writing, by the Secretary.
(5) The completed form must:
(a) include all the statements and information required by the form; and
(b) be signed (or authorised for electronic transmission) by a person who is authorised by the responsible person to provide the information.
Prescribed times
(6) Subject to subsection (7), the responsible person must provide the information:
(a) for each period between 1 April and 30 September in a year--before the end of 11 November in that year; and
(b) for each period between 1 October and the next 31 March--before the end of the next 12 May.
(7) However, for the period between a brand's start day and the next 31 March or 30 September, whichever is the sooner, the responsible person must provide the information:
(a) if the start day happens between 1 April and 30 September in a year--before the end of 11 November in that year; or
(b) if the start day happens between 1 October and the next 31 March--before the end of the next 12 May.