Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:2:p9
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 2 (pt 9/12)
Character Range: 47459–50194

trial.
quarter means a period of 3 months commencing on 1 January, 1 April, 1 July or 1 October in a year.
RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).
RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
RCM3 application means an application made under section 23 of the Act to register a complementary medicine, if:
 (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or
 (b) the application requires an independent evaluation of one of the following:
 (i) the safety of the medicine;
 (ii) the quality of the medicine;
 (iii) the efficacy of the medicine.
RCM4 application means an application made under section 23 of the Act to register a complementary medicine, if:
 (a) the application requires an independent evaluation of 2 of the following:
 (i) the safety of the medicine;
 (ii) the quality of the medicine;
 (iii) the efficacy of the medicine; or
 (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or
 (c) the application is for a medicine that is registered and is for one or more of the following:
 (i) an extension of indications of the medicine;
 (ii) new directions for use of the medicine;
 (iii) an increase in the target population for the medicine.
RCM5 application means an application made under section 23 of the Act to register a complementary medicine, if:
 (a) either:
 (i) the application requires an independent evaluation of the safety, quality and efficacy of the medicine; or
 (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and
 (b) the application is not an RCM1 application, an RCM2 application, an RCM3 application or an RCM4 application.
RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as