Commonwealth Numbered Regulations

1992 No. 19 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 9

  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 16C (4) or 16D (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.".