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 not been given.
(2) For paragraphs 71(1 )( b) and (c) of the Act, the application must be accompanied by:
(a) a certificate under paragraph 25(3 )( b) or subsection 26(4) or 26A(9) of the Therapeutic Goods Act 1989 stating the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or
(b) if the patentee does not have a certificate mentioned in paragraph ( a) -- information showing the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance.
Note: For providing a copy of a certificate mentioned in paragraph
( 2 )( a), see the definition of document in subsection 71(1) of
the Act.