Commonwealth Consolidated Regulations

[Index] [Table] [Search] [Search this Regulation] [Notes] [Noteup] [Previous] [Next] [Download] [Help]

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.


AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback