Commonwealth Consolidated Regulations

PATENTS REGULATIONS 1991 - REG 12.2C

  (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.