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Therapeutic Goods Regulations (Amendment)

Authoritative Version
  • - F1996B00411
  • No longer in force
SR 1992 No. 109 Regulations as made
These Regulations amend the Therapeutic Goods Regulations.
Administered by: Health
General Comments: This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003
Registered 01 Jan 2005
Tabling HistoryDate
Tabled HR29-Apr-1992
Tabled Senate29-Apr-1992
Gazetted 28 Apr 1992
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

 

 

 

 

 

 

 

Statutory  Rules  1992   No. 1091

__________________

 

 

Therapeutic Goods Regulations 2 (Amendment)

 

 

I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

 

          Dated 21 April 1992.

 

                                                                                         BILL HAYDEN

                                                                                        Governor-General

          By His Excellency’s Command,

 

 

PETER COOK

Minister of State for Industrial Relations

for and on behalf of the

Minister of State for Aged, Family

and Health Services

____________

 

1.   Amendment

1.1   The Therapeutic Goods Regulations are amended as set out in these Regulations.

 

[NOTE:  These Regulations commence on gazettal:  see Acts Interpretation Act 1901,

s. 48]

 


2.   Regulation 16C (Periods within which certain evaluations must be made)

2.1 Subregulation 16C (1):

Add at the end:

         “; and

               (c)  is not an application to which subregulation 16G applies.”.

 

2.2   Subregulation 16C (2):

Omit all the words from and including “the later” to the end of the subregulation, substitute “the day on which the Secretary sends a notification to the applicant under regulation 16B that indicates acceptance of the application in relation to the evaluation.”.

 

2.3   Paragraph 16C (4) (a):

Omit all the words from and including “marketing” to the end of the paragraph, substitute “marketing;”.

 

2.4   Subparagraph 16C (5) (b) (iii):

After “another report”, insert “(being an evaluation report)”.

 

2.5   Subregulation 16C (6) (definition of “acceptable country”):

Omit “Gazette, by a notice that states the relevant period in relation to the country,”, substitute “Gazette”.

 

 

3.   Regulation 16D (Periods within which certain applications must be decided)

 

3.1   Subregulation 16D (2):

Omit all the words from and including “the later” to the end of the subregulation, substitute “the day on which the Secretary sends a notification to the applicant under regulation 16B that indicates acceptance of the application.”.

 

3.2   Paragraph 16D (4) (a):

Omit all the words from and including “marketing” to the end of the paragraph, substitute “marketing;”.

 

3.3   Subparagraph 16D (5) (b) (iii):

After “another report”, insert “(being an evaluation report)”.


4.   New regulation 16G

4.1   After regulation 16F, insert in Part 3A:

 

Shorter evaluation period in certain cases

          “16G.  (1)  Subject to subregulation (2), this regulation applies to an application to register a drug that is a product of a kind specified in Schedule 10 if:

               (a)  the application is received by the Secretary on or after 1 July 1992; and

               (b)  the application requires an evaluation under section 25 of the Act; and

               (c)  the sponsor of the application holds a registration for a drug that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.

 

             “(2)  This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre-clinical or bio-equivalence data.

 

             “(3)  The provisions of subregulations 16F (3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.”.

 

 

____________________________________________________________

NOTES

 

1.      Notified in the Commonwealth of Australia Gazette on 28 April 1992.

 

2.      Statutory Rules 1990 No. 394 as amended by 1991 Nos. 84 and 485; 1992 Nos. 19 and 89.