Commonwealth Consolidated Regulations

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PPI compulsory licences--labelling and marking of product

             (1)  For paragraph 136F(1)(c) of the Act, the pharmaceutical product must be labelled or marked in a way that:

                     (a)  clearly identifies the product as being exported from Australia under the PPI compulsory licence; and

                     (b)  distinguishes the product from:

                              (i)  the same pharmaceutical product as sold in Australia; and

                             (ii)  the same pharmaceutical product as exported other than under the licence.

             (2)  For subregulation (1), the labelling or marking must:

                     (a)  be applied to:

                              (i)  the immediate package containing the pharmaceutical product; and

                             (ii)  any other package containing that package (whether or not other packages are involved); and

                     (b)  remain clear and legible at all times while the product is being exported.

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