Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This regulation applies to an application under section 70 of the Act for an extension of the term of a standard patent for a pharmaceutical substance for which pre-TGA marketing approval has been given.
(2) For paragraphs 71(1)(b) and (c) of the Act, the application must be accompanied by:
(a) a written statement by the person who gave the approval showing:
(i) that approval has been given; and
(ii) the date of the first approval; or
(b) if the patentee does not have a written statement mentioned in paragraph (a)--information showing:
(i) that approval has been given; and
(ii) the date of the first approval.
Note: For providing a copy of a written statement mentioned in paragraph (2)(a), see the definition of document in subsection 71(1) of the Act.