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Therapeutic Goods Regulations (Amendment)

Authoritative Version
  • - F1996B00409
  • No longer in force
SR 1992 No. 19 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 HR25-Feb-1992
Tabled Senate25-Feb-1992
Gazetted 31 Jan 1992
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

 

 

 

 

 

 

 

Statutory  Rules  1992   No. 191

__________________

 

 

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 31 January 1992.

 

                                                                                         BILL HAYDEN

                                                                                        Governor-General

          By His Excellency’s Command,

 

 

 

BEN HUMPHREYS

Minister of State for Veterans’ Affairs

 for and on behalf of the

Minister of State for Aged, Family and Health Services

____________

 

1.   Commencement

1.1   Subject to subregulation 1.2, these Regulations commence on 1 February 1992.

 

1.2   Regulation 10 commences on 1 July 1992.


 

2.   Amendment

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

 

 

3.   Regulation 4 (This Part not to apply to advertisements directed at health professionals etc.)

3.1   After subregulation 4 (2), insert:

           “(2A)  For the purposes of subregulation (2), a person is taken to be a member of an Australian branch of one of those bodies if, and only if, the person has the qualifications and training that are necessary or appropriate for membership of the relevant body.”.

 

 

4.   New regulation 5A

4.1   After regulation 5, insert:

 

This Part not to apply to advertisements for exported goods

            “5A.  (1)  Subject to subregulation (2), this Part does not apply to advertisements solely for therapeutic goods that have been exported or are intended exclusively for export.

 

             “(2)  Regulation 7 applies to advertisements of that kind.”.

 

 

5.   Regulation 6 (Advertising offences)

5.1   Subparagraph 6 (1) (d) (ii):

Omit “authority,”, substitute “authority (including a foreign government or foreign government authority),”.

 

5.2   Subparagraph 6 (1) (d) (ii):

Add at the end “or a statement authorised or required by a government or government authority (including a foreign government or foreign government authority)”.

 

5.3   Paragraph 6 (1) (f):

Add at the end “other than goods of a kind mentioned in paragraph (g).”.

 


 

5.4   Subregulation 6 (1):

After paragraph (f), insert:

            “; or

               (g)  if the goods are therapeutic goods, or come within a class of therapeutic goods, that:

                           (i)  are exempt under subregulation 12 (1A) or regulation 12A from the operation of Part 3 of the Act; or

                          (ii)  have been approved under subsection 19 (1) of the Act for importation into, exportation from or supply within Australia.”.

 

5.5   Subregulation 6 (2):

Omit “subsection”, substitute “subregulation”.

 

 

6.   Regulation 12B (Exemptions for special and experimental uses)

6.1   Subparagraph 12B (1) (c) (iv):

Omit “therapeutic goods” (twice occurring), substitute “drugs”.

 

 

7.   Regulation 13 (Change of person in whose name goods are listed or registered)

7.1   After subregulation 13 (4), insert:

           “(4A)  If a person in relation to whom therapeutic goods are registered or listed:

               (a)  changes his, her or its name; or

               (b)  being a corporation, amalgamates with another corporation under a name that is different from the name of the person in the Register;

the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.

 

           “(4b)  The new name must be entered in the Register as the name of the person in relation to whom the therapeutic goods are registered or listed.”.

 

7.2   Subregulation 13 (5):

Omit “(4) (d),”, substitute “(4) (d) or subregulation (4A),”.


 

7.3   Subregulations 13 (6) and (7):

Omit “therapeutic goods”, substitute “therapeutic goods, or of the new name of a person and the circumstance giving rise to it,”.

 

 

8.   Regulation 15 (Application of registration or listing number to goods)

8.1   Paragraph 15 (c):

Before “in each case” (first occurring), insert “subject to subregulation (2),”.

 

8.2   Add at the end:

             “(2)  If the Secretary is satisfied that compliance with paragraph (1) (c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1) (c) (i) or (ii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.”.

 

 

9.   New regulations 16a to 16e (inclusive)

9.1   After regulation 16, insert:

 

PART 3A—APPLICATIONS FOR

EVALUATION OF CERTAIN DRUGS

 

Interpretation—working day

          “16A.  (1)   In this Part, ‘working day’ means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.

 

             “(2)  The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:

               (a)  the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; and


 

               (b)  the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and

               (c)  any other period to which the applicant or sponsor agrees in writing for the purposes of this subregulation.

 

Notification of acceptance or rejection of application

          “16B.  (1)  If the Secretary receives an application:

               (a)  under section 23 of the Act that requires an evaluation to which regulation 16C applies; or

               (b)  to which regulation 16D applies;

he or she must send a notification in writing to the applicant that states whether the application has been accepted or rejected.

 

             “(2)  A notification must be sent:

               (a)  if the application to which it relates is one that satisfies the conditions stated in subregulation 16(4) or 16(4)within 20 working days; or

               (b)  in any other case—within 40 working days;

of the day of receipt of the application.

 

Periods within which certain evaluations must be made

          “16C.  (1)  Subject to paragraph (4) (d), this regulation applies to an evaluation of a drug that is a product of a kind specified in Schedule 10 if the application in relation to the evaluation:

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

               (b)  requires an evaluation under section 25 of the Act.

 

             “(2)  A reference in this regulation to a period in relation to an evaluation to which this regulation applies is a reference to the period that commences on the later of:

               (a)  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; and

               (b)  the day on which the fee payable under subsection 24 (1) of the Act for the application is paid.


 

             “(3)  An evaluation to which this regulation applies must be completed within whichever of the following periods applies:

               (a)  if the evaluation satisfies the conditions stated in subregulation (4)—175 working days;

               (b)  in any other case—255 working days.

 

             “(4)  The conditions referred to in paragraph (3) (a) are:

               (a)  that the evaluation relates to a drug that, in each of 2 acceptable countries, has been approved for general marketing within the relevant period that applies in relation to those countries respectively; and

               (b)  that the formulation, directions for use and indications of the drug are identical to those evaluated and approved for marketing in those 2 countries; and

               (c)  that the Secretary has, in relation to the evaluation, 2 evaluation reports on the drug that satisfy the requirements of subregulation (5); and

              (d)  that the application is received by the Secretary on or after 1 September 1992.

 

             “(5)  The requirements referred to in paragraph (4) (c) for the evaluation reports (in this subregulation called ‘the relevant reports’) are:

               (a)  that the relevant reports were made respectively by a competent regulatory authority in each of the 2 countries referred to in paragraph (4) (b); and

               (b)  that neither of the relevant reports is, wholly or in part, based on:

                           (i)  the other relevant report; or

                          (ii)  any other evaluation report that is a report on which the other relevant report was based; or

                         (iii)  any other evaluation report that is based on another report if the other relevant report was based on that other report or any evaluation report that was based on that other report.

 

             “(6)  In this regulation:

acceptable country’ means a country that the Minister has notified in the Gazette, by a notice that states the relevant period in relation to the country, as an acceptable country for the purposes of this regulation;


 

‘evaluation report’ does not include a report prepared by or on behalf of the applicant or sponsor and submitted to a regulatory authority in connection with an application for registration of, or variation of information in a register about, therapeutic goods;

based on’, in relation to an evaluation report, includes compiled by reference to or in reliance on;

relevant period’, in relation to an acceptable country, means the period stated in relation to the country in a notice under the definition of ‘acceptable country’.

 

Periods within which certain applications must be decided

          “16D.  (1)  Subject to paragraph (4) (d), this regulation applies to an application (other than an application to which regulation 16f applies) concerning an evaluation of a drug that is a product of a kind specified in Schedule 10 if the application:

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

               (b)  asks the Secretary under subsection 32 (5) of the Act to vary the entry of the drug in the Register.

 

             “(2)  A reference in this regulation to a period, in relation to an evaluation of an application to which this regulation applies, is a reference to the period that commences on the later of:

               (a)  the day on which the Secretary sends a notification to the applicant under regulation 16B that indicates acceptance of the application; and

               (b)  the day on which the fee payable under Schedule 9 for the application is paid.

 

             “(3)  An application to which this regulation applies must be decided, and notification given to the applicant, within whichever of the following periods applies:

               (a)  if the application satisfies the conditions stated in subregulation (4)—175 working days;

               (b)  in any other case—255 working days.

 

             “(4)  The conditions referred to in paragraph (3) (a) are:

               (a)  that the application relates to a drug that, in each of 2 acceptable countries, has been approved for general marketing within the relevant period that applies in relation to those countries respectively; and


 

               (b)  that the formulation, directions for use and indications of the drug are identical to those evaluated and approved for marketing in those 2 countries; and

               (c)  that the Secretary has 2 evaluation reports on the drug that satisfy the requirements of subregulation (5); and

              (d)  that the application is received by the Secretary on or after 1 September 1992.

 

             “(5)  The requirements referred to in paragraph (4) (c) for the evaluation reports (in this subregulation called ‘the relevant reports’) are:

               (a)  that the relevant reports were made respectively by a competent regulatory authority in each of the 2 countries referred to in paragraph (4) (b); and

               (b)  that neither of the relevant reports is, wholly or in part, based on:

                           (i)  the other relevant report; or

                          (ii)  any other evaluation report that is a report on which the other relevant report was based; or

                         (iii)  any other evaluation report that is based on another report if the other relevant report was based on that other report or any evaluation report that was based on that other report.

 

             “(6)  The definitions in subregulation 16c (6) apply to this regulation.

 

Failure to decide an application within specified time

          “16E.  The failure to decide, within the relevant time stated in paragraph 16D (3) (a) or (b), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.”.

 

 

10.   New regulation 16F

10.1   After regulation 16E, insert:


 

Applications under subsection 32 (5) of the Act—periods within which certain decisions must be made

           “16F.  (1)  Subject to subregulation (2), this regulation applies to an application, in relation to a drug included in the Register that is a product of a kind specified in Schedule 10, to vary the information in the Register concerning the drug in relation to:

               (a)  the specifications for the active ingredient, finished product or excipients; or

               (b)  the method of manufacture of the active ingredient; or

               (c)  the manufacturing procedure for the finished product; or

              (d)  the site of manufacture of the active ingredient or the finished product; or

               (e)  the shelf life; or

               (f)  the storage conditions; or

               (g)  the labelling; or

               (h)  any other particular that is not a particular mentioned in subsection 16 (1) of the Act.

 

             “(2)  This regulation does not apply to an application that:

               (a)  in the opinion of the Secretary, needs to be supported by clinical, pre-clinical or bio-equivalence data; or

               (b)  applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16 (1) of the Act.

 

             “(3)  In the case of an application to which this regulation applies, the Secretary must:

               (a)  decide the application and notify the applicant of the decision; or

               (b)  raise an objection concerning the application;

within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.

 

             “(4)  If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.


 

             “(5)  If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.”.

 

 

11.   Regulation 22 (Transfer of licences)

11.1   After subregulation 22 (4), insert:

           “(4A)  If a person who is the holder of a licence:

               (a)  changes his, her or its name; or

               (b)  being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;

the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.

 

           “(4B)  The licence has effect as if it had been granted to the holder in the holder’s new name.”.

 

11.2   Subregulations 22 (5), (6) and (8):

Omit “(3) (b) or (4) (b),”, substitute “(3) (b), (4) (b) or (4A) (a) or (b),”.

 

 

12.   New regulation 43AA

12.1   After regulation 43, insert:

 

Fee for evaluation—reduction in certain circumstances

        “43AA.  (1)  The fee payable under Schedule 9 for an application to which regulation 16D applies is reduced by 25% if the Secretary does not notify the applicant of the decision on the application within the period specified in subregulation 16D (3) that applies to the application.

 

             “(2)  In the case of an application mentioned in subregulation (1):

               (a)  the amount payable on lodgment of the application is the amount of the fee reduced by 25%; and

               (b)  if the reduction mentioned in that subregulation does not apply, the remainder of the fee is payable on the notification of the decision on the application.”.


 

13.   Schedule 3 (Therapeutic goods required to be included in the Part of the Register for registered goods)

13.1   After the heading, insert:

 

PART 1—THERAPEUTIC DEVICES ATTRACTING A HIGHER FEE, AND DRUGS”.

 

13.2   Item 2:

Omit from paragraph (b) “5, 6, 8, 9, 10”, substitute “6, 8, 9”.

 

13.3   Item 2:

After paragraph (b), insert:

             “; or

                     (c)   referred to in item 1, 2 or 3 in Schedule 5A;”.

 

13.4   Item 3:

After “devices” (first occurring), insert “, other than devices of a kind mentioned in Part 2,”.

 

13.5   Item 3:

Omit from subparagraph (g) (i) “fats, waxes or varnishes”, substitute “waxes”.

 

13.6   Item 3:

Omit subparagraphs (g) (ii) and (iii).

 

13.7   Add at the end:

 

PART 2—THERAPEUTIC DEVICES ATTRACTING A LOWER FEE

 

1                          therapeutic devices, to which a standard determined under subsection 10 (1) of the Act applies, that are implantable bradycardia pacemakers, or implantable pacemaker leads (other than leads designed exclusively for non-bradycardia applications), connectors or adapters, if:

                                    (a) the therapeutic devices are constructed of materials used in the manufacture of devices that the Secretary has approved for inclusion in the Register; and

                                    (b)   the Secretary has approved for inclusion in the Register therapeutic devices that:

                                                     (i)   are made by the same manufacturer, have the same indications, and for which the same performance is claimed as the first-mentioned therapeutic devices; and

                                                    (ii)   consist of the same materials in parts of the devices that are intended to make contact with tissue as are contained in the corresponding parts of the first-mentioned therapeutic devices

2                          therapeutic devices, to which a standard determined under subsection 10 (1) of the Act applies, that are bedside or ambulatory infusion pumps”.

 

 

14.   Schedule 4 (Therapeutic goods required to be included in the Part of the Register for listed goods)

14.1   Part 1, item 2:

Omit “5, 6 or 7” from paragraph (b), substitute “ 6, 7 or 11”.

 

14.2   Part 1, item 2:

After paragraph (b), add:

             “; or

                     (c)   item 1 or 3 of Schedule 5A applies;”.

 

14.3   Part 1, item 4:

Omit the item, substitute:

4                        mother tinctures and homoeopathic preparations consisting of or containing a dilution of mother tincture not exceeding a 1 thousand-fold dilution of a mother tincture that:

                                    (a)   need not be sterile; and

                                    (b)   is not subject to a Schedule to the Poisons Standard otherwise than because of a component of a homoeopathic preparation that is more dilute than a 1,000-fold dilution of a mother tincture”.

 

14.4   Part 2:

After “Nicotinamide”, insert “Nicotinamide ascorbate”.

 

14.5   Part 2:

Omit “Panthenol”, substitute:

                     “d-Panthenol

                             dl-Panthenol”.

 

14.6   Part 2:

Omit “Retinol”.


 

14.7   Part 5:

After the entry commencing “Fish oils”, insert the following entry:

                     “Fish oils used as a source of vitamins”.

 

 

15.   Schedule 5

15.1   Item 1, paragraph (c):

Add at the end “or the drugs have been approved, or are included in a class of drugs that has been approved, under regulation 5 of the Customs (Prohibited Imports) Regulations for importation into Australia”.

 

15.2   Item 1, paragraph (d):

After “4”, insert “or Schedule 8”.

 

15.3   Item 2:

Add at the end:

          “; and

                     (c)   are not intended for use in clinical trials on humans”.

 

 

16.   Schedule 6 (Therapeutic devices prescribed for the purposes of paragraph 26 (1) (g) of the Act)

16.1   Item 3, paragraph (c):

Omit the paragraph, substitute:

              “(c)   bandages, dressings, adhesive tapes and similar products (other than casting materials);”.

 

16.2   Item 3, paragraph (f):

Omit item (iv).

 

 

17.   Schedule 7 (Therapeutic goods exempt from the operation of Part 4 of the Act unless supplied as pharmaceutical benefits)

17.1   Item 4,, paragraph (c):

Omit the paragraph, substitute:

              “(c)   bandages, dressings, adhesive tapes and similar products (other than casting materials);”.


 

17.2   Item 4:

Omit subparagraph (g) (iv).

 

 

18.   Schedule 9 (Fees)

18.1   Item 2, paragraph (a):

Add at the end “or an application for a therapeutic device of a kind mentioned in Part 2 of Schedule 3”.

 

18.2   Item 2, paragraph (b):

After “(i)”, insert “or (ii)”.

 

18.3   Item 4:

Omit paragraph (a), substitute:

              “(a)   human clinical information comprising:

                                     (i)   not more than 50 pages                                          3,000

                                    (ii)   more than 50 but not more than                           9,600

                                            200 pages                                                 

                                   (iii)   more than 200 but not more than                        21,600

                                            2,000 pages                                                                                                                                              (iv)                          more than 2,000 pages                         42,000”.

 

18.4   Item 4:

Omit “5,000” from the 3rd column of subparagraph (b) (i), substitute “6,000”.

 

18.5   Item 4:

Omit “18,000” from the 3rd column of subparagraph (b) (ii), substitute “21,600”.

 

18.6   Item 4:

Omit “2,900” from the 3rd column of subparagraph (c) (ii), substitute “3,480”.

 

18.7   Item 4:

Omit “6,400” from the 3rd column of subparagraph (c) (iii), substitute “7,680”.


18.8   After item 5, insert:

5A                     evaluation fee for the purposes of subsection 24 (1)                      

                            of the Act in respect of a therapeutic device of a                           

                            kind mentioned in Part 2 of Schedule 3                                  1,700”.

 

18.9   Item 9:

Omit from paragraphs (a) and (b) “represented, to be”, substitute “represented to be,”.

 

 

19.   New Schedule 10

19.1   Add at the end:

 

                                               SCHEDULE 10                Subregulations 16C (1),

                                                                                                                        16D (1) and 16f (1)

____________________________________________________________

Column 1          Column 2

                               

Item No.            Product

____________________________________________________________

 

1                          drugs containing chemical or biological entities not present in any therapeutic goods included in the Register

2                          medical gases

3                          drugs that:

                                    (a)   come within Schedule 4 or Schedule 8 to the Poisons Standard; or

                                    (b)   would come within 1 of those Schedules if marketed in a different pack size

4                          vaccines

5                          allergens

6                          biotechnology drugs

7                          immunoglobulins

8                          radio contrast agents

9                          radiopharmaceuticals

10                        dialysis solutions

11                        irrigation solutions

12                        special dosage forms such as transdermal systems and osmotic pumps

13                        drugs referred to the Drug Evaluation Branch of the Therapeutic                                                Goods Administration within the Department by the Compliance Branch                                 of that Administration”.

____________________________________________________________


 

NOTES

 

1.      Notified in the Commonwealth of Australia Gazette on 31 January 1992.

 

2.      Statutory Rules 1990 No. 394 as amended by 1991 Nos. 84 and 485.