4Definitions

4 Definitions

Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:

advertise;
device number;
listing number;
Register;
registration number;

(f) Secretary;
(g) therapeutic goods; and
(h) Therapeutic Goods Advertising Code.

In this instrument:

Act means the Therapeutic Goods Act 1989.

case means a case created by the Therapeutic Goods Administration:

(a) in response to a complaint; or

(b) following a decision of the Therapeutic Goods Administration to undertake an investigation on its own initiative, where it reasonably suspects that an advertisement or dissemination of generic information contravenes the Act, Regulations or Therapeutic Goods Advertising Code.

case number means any combination of numbers, symbols and letters assigned by the Therapeutic Goods Administration to a case.

complaint means a complaint alleging that an advertisement or the dissemination of generic information contravenes the Act, Regulations or Therapeutic Goods Advertising Code, which was:

(a) made by a person to the Therapeutic Goods Administration; or
(b) made by a person to the Complaints Resolution Panel and led to a recommendation being made by the Complaints Resolution Panel to the Secretary under regulation 42ZCAI of the old Regulations; or
(c) referred to the Therapeutic Goods Administration by a body or an authority.

Complaints Resolution Panel has the same meaning as in the old Regulations.

generic information has the same meaning as in section 42B of the Act.

old Regulations means the Therapeutic Goods Regulations 1990 as in force immediately before the commencement of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018.

Note: Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 commenced on 1 July 2018.

outcome means the outcome of a case, or subsequent related action or proceedings in relation to that case, including:

(a) a finding that there is no contravention of the Act, Regulations or Therapeutic Goods Advertising Code;