Commonwealth Consolidated Regulations

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Process substantially transforming medicines in Australia

             (1)  For the purposes of paragraph 255(2)(c) of the Australian Consumer Law, this regulation prescribes a process that medicines have undergone in Australia to be substantially transformed in Australia.

             (2)  This regulation applies to medicines that are complementary medicines (within the meaning of the Therapeutic Goods Regulations 1990 ) and are either:

                     (a)  listed goods; or

                     (b)  registered goods.

             (3)  The process is the carrying out of the last step (except one covered by subregulation (4)) in the manufacture of the dosage form of medicines that:

                     (a)  occurs at premises in Australia; and

                     (b)  is authorised by a licence to occur in relation to those medicines at those premises.

             (4)  This subregulation covers the following steps:

                     (a)  covering of the dosage form of medicines in containers;

                     (b)  packaging of the dosage form of medicines;

                     (c)  labelling of the dosage form of medicines;

                     (d)  storage of the dosage form of medicines (whether in packaging or not);

                     (e)  testing of the dosage form of medicines;

                      (f)  release for supply of the dosage form of medicines.

             (5)  A term (except "process") used in this regulation and the Therapeutic Goods Act 1989 has the same meaning in this regulation as it has in that Act.

Note:          Terms whose meaning is affected include "containers", "dosage form", "labelling", "licence", "listed goods", "manufacture", "medicines", "packaging", "premises", "registered goods", "release for supply", "storage" and "testing".

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