Commonwealth Consolidated Regulations

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS 1960 - REG 37H

         (1)   For paragraph 99ADC (1) (a) of the Act, the information to be provided for the supply of a listed brand of a pharmaceutical item for a reporting period is:

                (a)    the name of the responsible person; and

               (b)    the name of the drug in the pharmaceutical item; and

                (c)    the brand; and

               (d)    the form of the drug, including its strength; and

                (e)    the manner of administration of the form of the drug; and

                (f)    the number or quantity of units in a pack (for example, the number of tablets per pack); and

               (g)    the period to which the information relates; and

               (h)    for each period to which the information relates:

                          (i)    the sales revenue for the brand, excluding sales to public hospitals (expressed in Australian dollars, excluding GST and rounded to the nearest whole dollar, rounding 50 cents upwards); and

                         (ii)    the volume of the brand sold, based on the number of packs sold; and

                (i)    the kind of incentives (if any) given for the brand for the reporting period ; and

                (j)    the value of the incentives given for the brand for the reporting period (expressed in Australian dollars, excluding GST and rounded to the nearest whole dollar, rounding 50 cents upwards).

Note 1    The form issued by the Department for responsible persons to provide the information may include a list of different kinds of incentives (for example, rebates or cash backs) and the responsible person would fill in the values for the kind of incentives for which information is being provided.

Note 2    For  transitional arrangements, see Part 2 of the National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 5).

         (2)   However, for the first reporting period to which subregulation 37G (3) or (6) applies, the information mentioned in paragraph (1) (h) for the first month of the reporting period must be provided separately.

         (3)   If an incentive is given over a period of time or indirectly for a brand, the value of the incentive for the brand for the reporting period is the value apportioned to the brand for the reporting period.

Note    No methodology is prescribed for apportioning the value of incentives for a brand for a period. However, the methodology used by a responsible person should be reasonable and documented.

         (4)   If information must be provided under paragraph (1) (h), it must not also be provided under paragraph (1) (i) or (j).

         (5)   The information must relate to the period from the beginning of the reporting period to the end of the reporting period.

         (6)   For this regulation, incentives includes anything given as an incentive to take supply of the brand, whether given:

                (a)    before the supply of the brand, but on condition of taking supply; or

               (b)    at the time of the supply of the brand; or

                (c)    at a later date; or

               (d)    over a period of time; or

                (e)    directly for the brand; or

                (f)    indirectly for the brand (for example, for a group of brands or other products).