Commonwealth Consolidated Regulations

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PATENTS REGULATIONS 1991 - REG 6.10

Application with pre-TGA marketing approval

             (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.



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