Document ID: chunk:federal_register_of_legislation:F2024C00944:reg:6:p18
Version: federal_register_of_legislation:F2024C00944
Segment Type: reg
Provision Reference: reg 6 (pt 18/73)
Character Range: 198549–201427

as practicable after lodgement; and
 (b) lodge with the Registrar notice of the date when, and the place where, he or she complied with paragraph (a).
 (4) For subregulation (3), the applicant must serve the copy in accordance with Rules made by the Federal Court for the service of the application, as in force from time to time.

12.2B  PPI compulsory licences—notification requirements
 (1) This regulation sets out the notification requirements for paragraph 136E(1)(f) of the Act in relation to the importation of a pharmaceutical product into an eligible importing country.
 (2) Subregulation (3) applies if the eligible importing country is a WTO member.
 (3) The eligible importing country must have notified the Council for TRIPS in accordance with paragraph 2(a) of the Annex to the TRIPS Agreement.
 (4) Subregulation (5) applies if the eligible importing country is:
 (a) a least developed country; and
 (b) not a WTO member.
 (5) The eligible importing country must have given the Commissioner a written notice:
 (a) stating:
 (i) the name of the eligible importing country; and
 (ii) the name of the pharmaceutical product; and
 (iii) the expected quantity of the pharmaceutical product to be imported into the eligible importing country; and
 (b) confirming that, if the pharmaceutical product is patented in the eligible importing country, it:
 (i) has granted; or
 (ii) intends to grant;
  a compulsory licence that would accord with Articles 31 and 31bis of the TRIPS Agreement and the Annex to that Agreement if the Agreement and Annex applied to the eligible importing country.

12.2C  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.

12.2D  PPI compulsory licences—shipment information
 (1) For paragraph 136F(1)(d) of the Act, the following shipment information is prescribed in relation to each shipment of a pharmaceutical product:
 (a) the name of the pharmaceutical product;
 (b) the amount of the product in the shipment;
 (c) the name of the licensee;
 (d) the licensee's address for service;
 (e) the name of the eligible importing country;
 (f) if a person is importing the pharmaceutical product on behalf of, and