Document ID: chunk:federal_register_of_legislation:F2024C00944:reg:6:p19
Version: federal_register_of_legislation:F2024C00944
Segment Type: reg
Provision Reference: reg 6 (pt 19/73)
Character Range: 201193–203913

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 with the authorisation of, the eligible importing country—the name and address of the person;
 (g) a description of the packaging (including colour, size and shape) and the labelling or marking of the pharmaceutical product.
 (2) For paragraph 136F(1)(d) of the Act, the shipment information must be made available for at least the duration of the licence.

12.2E  PPI compulsory licences—giving information to the Commissioner
 (1) This regulation sets out for paragraph 136F(1)(h) of the Act the information that a licensee must give to the Commissioner in relation to the licence.

Grant of licence
 (2) The licensee must give the Commissioner the following information in relation to the grant of the PPI compulsory licence:
 (a) the date of the PPI order;
 (b) the place at which the PPI order was made;
 (c) the name and address of the licensee;
 (d) the licensee's address for service;
 (e) the name of the pharmaceutical product;
 (f) the quantity of the pharmaceutical product that the Federal Court has determined may be manufactured for export;
 (g) the eligible importing country to which the pharmaceutical product is to be exported;
 (h) the duration of the licence;
 (i) the identity of the patent;
 (j) the address of the website on which the shipment information is to be made available.
 (3) The information mentioned in subregulation (2) must be given to the Commissioner:
 (a) in the approved form; and
 (b) within 1 month after the Federal Court makes the order requiring the grant of the licence.

Amendment of licence
 (4) If the licence is amended by order under section 136G of the Act, the licensee must give the Commissioner the following information in relation to the amendment:
 (a) the date of the amending order;
 (b) the place at which the amending order was made;
 (c) details of the amendment.
 (5) The information mentioned in subregulation (4) must be given to the Commissioner:
 (a) in the approved form; and
 (b) within 1 month after the Federal Court makes the order amending the licence.

Revocation of licence
 (6) If the licence is revoked by order under section 136H of the Act, the licensee must give the Commissioner the following information in relation to the revocation:
 (a) the date of the revocation order;
 (b) the place at which the revocation order was made.
 (7) The information mentioned in subregulation (6) must be given to the Commissioner:
 (a) in the approved form; and
 (b) within 1 month after the Federal Court makes the