Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This section is made for the purposes of subsection 99ADC(1) of the Act.
Prescribed information
(2) The responsible person must provide the following information in relation to the supply of a brand of a pharmaceutical item:
(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 sold;
(i) the revenue from sales of the brand, excluding GST;
(j) if any incentive is given in relation to the brand:
(i) the kind of incentive; and
(ii) the value of the incentive, excluding GST.
(2A) Subsection (2) does not apply to a supply of a brand of a pharmaceutical item during a data collection period for the brand if:
(a) the supply is to a public hospital; and
(b) the drug in the pharmaceutical item had not been on F2 for at least 42 months at the end of the previous data collection period for the brand.
(3) If information is provided under paragraph (2)(i), the information must not also be provided under paragraph (2)(j).
(4) The information referred to in each of paragraphs (2)(h), (i) and (j), to the extent that the information relates to the brand's initial month, must be provided separately.
(5) An amount provided under paragraph (2)(i) or (j) must be:
(a) expressed in Australian dollars; and
(b) rounded to the nearest whole dollar, rounding 50 cents upwards.
Prescribed person
(6) The responsible person must provide the information to:
(a) Australian Healthcare Associates Pty Ltd (ABN 82 072 790 848); or
(b) if the responsible person receives written notice from the Department to provide the information to the Secretary--the Secretary.
Prescribed manner and form
(7) The responsible person must provide the information in a form approved, in writing, by the Secretary.
(8) 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
(9) Subject to subsection (10), 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.
(10) 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.