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PB 65 of 2011 Determinations/Health as made
This instrument determines the pharmacy location rules against which most applications made by pharmacists under section 90 of the National Health Act 1953 must comply.
Administered by: Health
General Comments: Transitional: The National Health (Australian Community Pharmacy Authority Rules) Determination 2006, also known as Determination No. PB 23 of 2006, as in force immediately before 18 October 2011, continues to apply in relation to the consideration, by the Authority, of an application made before 18 October 2011.

For application, saving and transitional provisions relating to the repeal of this determination, see sections 12 and 13 of the National Health (Australian Community Pharmacy Authority Rules) Determination 2018 (PB 46 of 2018).
Registered 26 Sep 2011
Tabling HistoryDate
Tabled HR11-Oct-2011
Tabled Senate11-Oct-2011
Date of repeal 03 Oct 2018
Repealed by National Health (Australian Community Pharmacy Authority Rules) Determination 2018 (PB 46 of 2018)

Commonwealth Coat of Arms

I, NICOLA ROXON, Minister for Health and Ageing, make this Determination under subsection 99L (1) of the National Health Act 1953.

Dated 13 September 2011

 

NICOLA ROXON


Contents

Part 1                          Preliminary

                        1      Name of Determination                                                                       3

                        2      Commencement                                                                                  3

                        3      Revocation                                                                                         3

                        4      Transitional                                                                                         3

                        5      Interpretation                                                                                      3

                        6      Meanings of approved premises and redundant premises                       5

                        7      Meaning of commercial establishment                                                  6

                        8      Measurement of distance between premises                                        7

                        9      Information to be considered by Authority                                            7

Part 2                          Recommendations by the Authority

                       10      When Authority must recommend approval of applicant                        8

                       11      When Authority must recommend applicant not be approved                8

Schedule 1                  Kinds of applications, and requirements in relation to those applications 9

Part 1                             Applications involving cancellation of existing approval                        9

Part 2                             Applications not involving cancellation of existing approval                11

Schedule 2                  General requirements                                                                      13

Schedule 3                  Requirements for applications involving cancellation of existing approval            14

Part 1                             All applications                                                                                 14

Part 2                             Particular applications                                                                       15

 

 


Part 1                 Preliminary

  

1              Name of Determination

         (1)   This Determination is the National Health (Australian Community Pharmacy Authority Rules) Determination 2011.

         (2)   This Determination may also be cited as Determination No. PB 65 of 2011.

2              Commencement

                This Determination commences on 18 October 2011.

3              Revocation

                The National Health (Australian Community Pharmacy Authority Rules) Determination 2006 made by the Minister on 21 June 2006, also known as Determination No. PB 23 of 2006, is revoked.

4              Transitional

                The National Health (Australian Community Pharmacy Authority Rules) Determination 2006, also known as Determination No. PB 23 of 2006, as in force immediately before 18 October 2011, continues to apply in relation to the consideration, by the Authority, of an application made before 18 October 2011.

5              Interpretation

         (1)   In this Determination:

Act means the National Health Act 1953.

application means an application under section 90 of the Act referred to the Authority.

Note   This Determination divides applications for approvals in relation to proposed premises into 2 classes:

·      applications that involve the cancellation of an existing approval (see Part 1 of Schedule 1); and

·      applications that do not involve the cancellation of an existing approval (see Part 2 of Schedule 1).

approved premises has the meaning given by subsection 6 (1).

commercial establishment has the meaning given by section 7.

existing approval has the meaning given by paragraph 10 (a).

existing premises has the meaning given by paragraph 10 (a).

facility means:

                (a)    a small shopping centre; or

               (b)    a large shopping centre; or

                (c)    a large medical centre; or

               (d)    a private hospital.

full-time means:

                (a)    for a prescribing medical practitioner, providing the services of a prescribing medical practitioner for at least 38 hours each week; and

               (b)    for a PBS prescriber, providing the services of a PBS prescriber for at least 38 hours each week.

gross leasable area means:

                (a)    for a shopping centre — the total floor area of the shopping centre excluding loading docks and car parks; and

               (b)    for a supermarket — the total floor area of the supermarket excluding loading docks.

large medical centre means a medical centre that:

(a)    is under single management; and

(b)    operates for at least 70 hours each week; and

(c)    has one or more prescribing medical practitioners at the centre for at least 70 hours each week.

large shopping centre means a shopping centre that:

                (a)    has a gross leasable area of at least 5 000 m2; and

               (b)    contains a supermarket that occupies a gross leasable area of at least 1 000 m2; and

                (c)    contains at least 50 other commercial establishments; and

               (d)    has customer parking facilities.

pharmacy has the meaning given by subsection 90 (3AB) of the Act.

prescribing medical practitioner means a medical practitioner who provides general practice services to the community in which he or she practises, including the issuing of prescriptions for pharmaceutical benefits.

proposed premises, in relation to an application, means the premises at which an applicant proposes to supply pharmaceutical benefits.

shopping centre means a group of shops and associated facilities that is under single management.

single management, for a shopping centre or medical centre:

                (a)    means management of the centre as a whole:

                          (i)    by one manager, or by 2 or more managers working cooperatively under an agreement; and

                         (ii)    to encourage the use of the centre as a single integrated facility; and

                        (iii)    including management of the following matters for the centre:

                                   (A)     security;

                                   (B)     pedestrian and vehicular access;

                                   (C)     cleaning;

                                   (D)     signage;

                                   (E)     trading hours;

                                    (F)     marketing;

                                   (G)     maintenance of buildings, common areas and utilities; and

               (b)    does not include independent owners or tenants of premises in a building or centre that cooperate:

                          (i)    on particular occasions; or

                         (ii)    in relation to some, but not all, of the matters mentioned in subparagraph (a) (iii) in relation to the building or centre.

small shopping centre means a shopping centre that:

                (a)    has a gross leasable area of at least 5 000 m2; and

               (b)    contains a supermarket that occupies a gross leasable area of at least 2 500 m2; and

                (c)    contains at least 15 other commercial establishments; and

               (d)    has customer parking facilities.

supermarket means a retail store or market the primary business of which is the sale of a range of food, beverages, groceries and other domestic goods.

Note 1   Authority, PBS prescriber and pharmaceutical benefit are defined in subsection 84 (1) of the Act. Pharmacist and Secretary are defined in subsection 4 (1) of the Act.

Note 2   Medical practitioner and private hospital are defined in subsection 3 (1) of the Health Insurance Act 1973 and have the same meaning in the Act as in the Health Insurance Act 1973 — see subsection 4 (1A) of the Act.

Same town

         (2)   If proposed premises are required to be in the same town as an approved premises, the proposed premises are taken to be in the same town if they are located in the same town and postcode as the approved premises.

         (3)   If proposed premises are required to be in the same town as an existing premises, the proposed premises are taken to be in the same town if they are located in the same town and postcode as the existing premises.

6              Meanings of approved premises and redundant premises

         (1)   In this Determination, approved premises are premises, other than premises that are redundant under subsection (2):

                (a)    in relation to which an approval granted under section 90 of the Act is in force; or

               (b)    in relation to which the Authority has recommended an applicant be approved under section 90 of the Act.

         (2)   Premises are redundant if all of the following apply:

                (a)    the premises are existing premises in relation to an application;

               (b)    the Authority has recommended that the applicant who made the application be approved under section 90 of the Act in relation to the proposed premises;

                (c)    the pharmacist approved in relation to the existing premises has requested, in writing, that if the applicant is to be approved in relation to the proposed premises, the existing approval will be cancelled immediately before the approval in relation to the proposed premises is granted;

               (d)    the pharmacist approved in relation to the existing premises has ceased to carry on business as a pharmacist at the approved premises;

                (e)    the Secretary:

                          (i)    is aware of the cessation and of the reason for it; and

                         (ii)    has agreed to cancel the existing approval only in accordance with a request of the kind mentioned in paragraph (c).

Note 1   Under paragraph 90E (b) of the Act, references in the Act to an approval granted under section 90 of the Act include references to an approval treated as having been granted under section 90 by paragraph 90E (a) of the Act.

Note 2   Under paragraph 91 (7) (c) of the Act, references in the Act to an approval granted under section 90 of the Act include references to an approval treated as having been granted under section 90 by paragraph 91 (7) (a) of the Act.

7              Meaning of commercial establishment

         (1)   In this Determination, subject to subsection (2):

commercial establishment means premises:

                (a)    in a shopping centre; and

               (b)    occupied by, or likely to be occupied by:

                          (i)    a shop where goods, food or beverages are sold retail; or

                         (ii)    a bar, café, restaurant or takeaway; or

                        (iii)    a business that provides services to customers.

         (2)   For subsection (1), commercial establishment does not include:

                (a)    commercial office space; or

               (b)    premises occupied by an accountant, analyst, architect, engineer, lawyer, planner, stockbroker or surveyor, unless the premises are occupied as a shopfront; or

                (c)    premises occupied by a real estate agent or an insurance company, agent or broker, unless the premises are occupied as a shopfront for the real estate agent or insurance company; or

               (d)    a council office or government or statutory corporation office or shopfront, other than an Australia Post shopfront, an Australian Broadcasting Corporation shop or a Medicare or Centrelink shopfront; or

                (e)    a car wash or car parking facilities; or

                (f)    a library; or

               (g)    a kindergarten or preschool; or

               (h)    a child care centre or child minding facility, unless the centre or facility is regularly available for use by customers of the shopping centre while the customers are at the shopping centre; or

                (i)    a storeroom or storage area; or

                (j)    a temporary selling point; or

               (k)    an automatic teller machine or automatic dispensing machine.

         (3)   In working out the number of commercial establishments in a shopping centre:

                (a)    2 or more commercial establishments occupied by, or likely to be occupied by, one business are counted as one commercial establishment; and

               (b)    the maximum number of shopfronts for accountants, analysts, architects, engineers, lawyers, planners, stockbrokers or surveyors that can be counted towards the total number of commercial establishments in a shopping centre is:

                          (i)    for a small shopping centre — one; or

                         (ii)    for a large shopping centre — 2.

8              Measurement of distance between premises

         (1)   In this Determination, a reference to the distance between 2 premises in a straight line is a reference to the distance, measured in a straight line, from the centre, at ground level, of the public entrance of the first premises to the centre, at ground level, of the public entrance of the second premises.

         (2)   In this Determination, a reference to the distance between 2 premises by the shortest lawful access route is a reference to the distance, measured by following the shortest lawful access route between the 2 premises, from the centre, at ground level, of the public entrance of the first premises to the centre, at ground level, of the public entrance of the second premises.

         (3)   If either premises has more than one public entrance, a reference to the distance between the 2 premises is a reference to the shortest such measurement that can be made in relation to the 2 premises.

9              Information to be considered by Authority

                The Authority may consider information provided by an applicant only if:

                (a)    the information was given at the time the application was made; or

               (b)    the Authority requested the information.

Part 2                 Recommendations by Authority

  

10            When Authority must recommend approval of applicant

                The Authority must recommend that an applicant be approved under section 90 of the Act in relation to particular premises if:

                (a)    for an application that involves the cancellation of an approval (the existing approval) that is in force in relation to approved premises (the existing premises):

                          (i)    the application states that it is one of the kinds mentioned in column 2 of an item in Part 1 of Schedule 1; and

                         (ii)    all the requirements set out in column 3 of that item are met; and

                        (iii)    all the requirements set out in Schedule 2 and Part 1 of Schedule 3 are met; and

                        (iv)    for an application described in column 2 of an item of Part 2 of Schedule 3 — the requirement set out in column 3 of that item is met; and

               (b)    for any other application:

                          (i)    the application states that it is one of the kinds mentioned in column 2 of an item in Part 2 of Schedule 1; and

                         (ii)    all the requirements set out in column 3 of that item are met; and

                        (iii)    all the requirements set out in Schedule 2 are met.

11            When Authority must recommend applicant not be approved

                The Authority must recommend that an applicant not be approved under section 90 of the Act in relation to particular premises if a requirement, under paragraph 10 (a) or (b), that applies in relation to the application is not met.


Schedule 1        Kinds of applications, and requirements in relation to those applications

(section 10)

Part 1          Applications involving cancellation of existing approval

 

Item

Kind of application

Requirements

121

Expansion or contraction

The application:

   (a)  is of the kind mentioned in subsection 90 (3AE) of the Act; and

  (b)  has been referred to the Authority under subsection 90 (3AF) of the Act.

122

Relocation within a facility

The proposed premises are in the same facility as the existing premises.

123

Relocation within the same town (10 km)

1.   The proposed premises are in the same town as the existing premises.

2.   The proposed premises are at least 10 km, by the shortest lawful access route, from the nearest approved premises other than the existing premises.

124

Short distance relocation (1 km)

1.   The proposed premises are no more than 1 km, in a straight line, from the existing premises.

2.   Either:

   (a)  the existing premises are not in a facility; or

  (b)  the existing premises are in a facility and the proposed premises are at least 500 m, in a straight line, from all approved premises not located in the facility.

125

Short distance relocation (more than 1 km)

1.   The application was made before 16 April 2012.

2.   The proposed premises are more than 1 km, but not more than 1.5 km, in a straight line, from the existing premises.

3.   Either:

   (a)  if the existing premises are not in a private hospital or large shopping centre — the proposed premises must be at least 500 m, in a straight line, from all approved premises other than approved premises that are no more than 1 km, in a straight line, from the existing premises; or

 

 

  (b)  if the existing premises are in a private hospital or large shopping centre — the proposed premises must be at least 500 m, in a straight line, from all approved premises other than approved premises in the private hospital or large shopping centre.

4.   The Authority is satisfied that, before 18 October 2011, the applicant had a legal right to occupy the proposed premises on or after 18 October 2011.

126

Long distance relocation

1.   The application was made before 16 April 2012.

2.   The proposed premises are:

   (a)  at least 1.5 km, in a straight line, from the nearest approved premises; or

  (b)  if paragraph (a) does not apply — at least 2 km, by the shortest lawful access route, from each approved premises that is within 1.5 km, in a straight line, from the proposed premises.

3.   The Authority is satisfied that, before 18 October 2011, the applicant had a legal right to occupy the proposed premises on or after 18 October 2011.

127

Relocation to a population growth area

1.   The application was made before 16 April 2012.

2.   The proposed premises are at least 500 m, in a straight line, from the nearest approved premises.

3.   The Authority is satisfied that:

   (a)  the resident population of the catchment area for the proposed premises:

         (i)   is, for most of the year, at least 8 000; and

        (ii)   has grown by at least 5% in each of the 2 years before the day on which the application was made; and

  (b)  the catchment area for the proposed premises contains only one approved premises; and

   (c)  the applicant had, before 18 October 2011, a legal right to occupy the proposed premises on or after 18 October 2011.

Part 2          Applications not involving cancellation of existing approval

 

Item

Kind of application

Requirements

130

New pharmacy (at least 1.5 km)

1.   The proposed premises are at least 1.5 km, in a straight line, from the nearest approved premises.

2.   The Authority is satisfied that, at all relevant times, there is:

   (a)  within 500 m, in a straight line, from the proposed premises:

         (i)   at least the equivalent of one full-time prescribing medical practitioner; and

        (ii)   a supermarket with a gross leasable area of at least 1 000 m2; or

  (b)  within 500 m, in a straight line, from the proposed premises a supermarket with a gross leasable area of at least 2 500 m2.

3.   For this item, all relevant times means:

   (a)  on the day on which the application was made; and

  (b)  the day on which the application is considered by the Authority.

131

New pharmacy (at least 10 km)

The proposed premises are at least 10 km, by the shortest lawful access route, from the nearest approved premises.

132

New additional pharmacy (at least 10 km)

1.   The proposed premises are:

   (a)  located in the same town as an approved premises; and

  (b)  at least 200 m, in a straight line, from the nearest approved premises; and

   (c)  at least 10 km, by the shortest lawful access route, from any approved premises other than the approved premises mentioned in paragraph (b).

2.   The Authority is satisfied that, at all relevant times, located in the same town as the proposed premises are:

   (a)  at least the equivalent of 4 full-time prescribing medical practitioners practising; and

  (b)  one or 2 supermarkets which occupy a combined total gross leasable area of at least 2 500 m2.

3.   For this item, all relevant times means:

   (a)  on the day on which the application was made; and

  (b)  the day on which the application is considered by the Authority.

133

New pharmacy in a facility (small shopping centre)

1.   The proposed premises are in a small shopping centre.

2.   The proposed premises are at least 500 m, in a straight line, from the nearest approved premises.

3.   There are no approved premises in the small shopping centre.

134

New pharmacy in a facility (large shopping centre)

1.   The proposed premises are in a large shopping centre.

2.   There are:

   (a)  for a shopping centre that contains at least 50, but fewer than 100, commercial establishments — no approved premises in the shopping centre; or

  (b)  for a shopping centre that contains at least 100, but fewer than 200, commercial establishments — no more than one approved premises in the shopping centre; or

   (c)  for a shopping centre that contains at least 200 commercial establishments — no more than 2 approved premises in the shopping centre.

135

New pharmacy in a facility (private hospital)

1.   The proposed premises are in a private hospital.

2.   There are no approved premises in the private hospital.

3.   The hospital authority for the private hospital is not approved under section 94 of the Act.

4.   The private hospital is registered or licensed, under the law of the State or Territory in which the private hospital is located:

   (a)  to contain at least 150 beds to provide health services to patients; or

  (b)  to treat, accommodate or lodge at least 150 patients at any one time.

136

New pharmacy in a facility (large medical centre)

1.   The proposed premises are in a large medical centre.

2.   There are no approved premises in the large medical centre.

3.   The proposed premises are at least 500 m, in a straight line, from the nearest approved premises other than an approved premises in a small shopping centre, large shopping centre or private hospital.

4.   The Authority is satisfied that, at all relevant times, the number of PBS prescribers at the medical centre is equivalent to at least 8 full-time PBS prescribers, of which at least 7 PBS prescribers must be prescribing medical practitioners.

5.   For this item, all relevant times means:

   (a)  on the day on which the application was made; and

  (b)  at all times during the 2 months before the day on which the application was made; and

   (c)  at all times during the 2 months before the day on which the application is considered by the Authority.

6.   The Authority is satisfied that the applicant will make all reasonable attempts to ensure that the operating hours of the proposed premises will meet the needs of the patients of the medical centre.

Schedule 2        General requirements

(section 10)

  

Item

Requirements

211

The Authority is satisfied that:

   (a)  the applicant had, on the day the application was made, and has, on the day the Authority makes a recommendation in relation to the application, a legal right to occupy the proposed premises on or after the day the application was made; and

  (b)  the proposed premises, on the day the application was made and on the day the Authority makes a recommendation in relation to the application:

         (i)   could be used for the operation of a pharmacy under applicable local government and State or Territory laws relating to land development; and

        (ii)   would be accessible by members of the public at large; and

   (c)  within 6 months after the day on which the Authority makes a recommendation in relation to the application, the applicant will be able to begin operating a pharmacy at the proposed premises; and

  (d)  the proposed premises are not directly accessible by the public from within a supermarket.

 

Note   The requirement in subparagraph (b) (i) would be satisfied if, for example, planning approval for the proposed pharmacy has been obtained or, if this is not necessary in the State or Territory where the pharmacy would be located, the proposed premises are on land that is zoned so as to enable the operation of a pharmacy. An application to obtain a building works approval or a certificate of occupancy, or similar, is not required to satisfy this requirement. However, it may be needed for compliance with requirement (c), depending on the operation of applicable State or Territory land development laws.

212

The Authority is satisfied that, on the day on which the application is made, the proposed premises are not approved premises.

Schedule 3        Requirements for applications involving cancellation of existing approval

(section 10)

Part 1          All applications

 

Item

Requirements

311

The Authority is satisfied that:

   (a)  the pharmacist approved in relation to the existing premises has requested, in writing, that, if an approval is to be granted in relation to the proposed premises, the existing approval will be cancelled immediately before the approval is granted; and

  (b)  if the pharmacist approved in relation to the existing premises has ceased to carry on business as a pharmacist at the existing premises, the Secretary:

         (i)   is aware of the cessation and of the reasons for it; and

        (ii)   has agreed to cancel the existing approval only in accordance with a request of the kind mentioned in paragraph (a).

312

The Authority is satisfied that:

   (a)  on the day the application is made, one or more approvals in relation to the existing premises have been in force, immediately prior to the day the application was made, for a continuous period of at least 2 years; or

  (b)  if paragraph (a) does not apply:

         (i)   the proposed premises are in the same facility as the existing premises; or

        (ii)   the proposed premises are in the same town as the existing premises; or

       (iii)   the purpose of the application is to allow the pharmacy operated by the applicant at the existing premises to move to the proposed premises while the existing premises are renovated or refurbished; or

       (iv)   the proposed premises are renovated or refurbished premises that are the same, or substantially the same, premises previously occupied by the pharmacy operated by the applicant or by the previous owner of the pharmacy; or

        (v)   there are exceptional circumstances; or

       (vi)   both:

               (A)    the application involves the cancellation of an existing approval that was granted following an application of the kind mentioned in subsection 90 (3AE) of the Act; and

               (B)     the existing approval, and the approval the cancellation of which was involved in the application for the existing approval, have been in force for a total of at least 2 years; or

      (vii)   the application:

               (A)    is of the kind mentioned in subsection 90 (3AE) of the Act; and

               (B)     has been referred to the Authority under subsection 90 (3AF) of the Act.

Part 2          Particular applications

 

Item

Description of application

Requirement

313

An application:

   (a)  involving the cancellation of an existing approval that was granted:

         (i)   following an application of the kind mentioned in item 130 of Schedule 1; or

        (ii)   following an application:

                (A)    of the kind mentioned in subsection 90 (3AA) or (3AE) of the Act; and

                (B)    that involved the cancellation of an approval that was granted in the circumstances mentioned in subparagraph (i); or

       (iii)   following an application of the kind mentioned in Part 1 of Schedule 1 that involved the cancellation of an existing approval what was granted following an application of the kind mentioned in subparagraph (i) or (ii); and

  (b)  that is made within 5 years after the day on which the approval granted in the circumstance mentioned in subparagraph (a) (i) was granted.

The proposed premises are not more than 1 km, in a straight line, from the premises that were approved following an application of the kind mentioned in subparagraph (a) (i) of column 2.

 

314

An application:

   (a)  involving the cancellation of an existing approval that was granted:

         (i)   following an application of the kind mentioned in item 113 of Schedule 1 to National Health (Australian Community Pharmacy Authority Rules) Determination 2006 (No. PB 23 of 2006); or

        (ii)   following an application:

                (A)    of the kind mentioned in subsection 90 (3AA) or (3AE) of the Act; and

                (B)    that involved the cancellation of an approval that was granted in the circumstance mentioned in subparagraph (i); or

       (iii)   following an application of the kind mentioned in Part 1 of Schedule 1 that involved the cancellation of an existing approval that was granted following an application of the kind mentioned in subparagraph (i) or (ii); and

The proposed premises are not more than 1.5 km, in a straight line, from the premises that were approved following an application of the kind mentioned in subparagraph (a) (i) of column 2.

 

       (iv)   following an application of the kind mentioned in Part 1 of Schedule 1 to the National Health (Australian Community Pharmacy Authority Rules) Determination 2006 (No. PB 23 of 2006) that involved the cancellation of an existing approval that was granted following an application of the kind mentioned in subparagraph (i) or (ii); and

  (b)  that is made within 5 years after the day on which the approval granted in the circumstance mentioned in subparagraph (a) (i) was granted.

 

315

An application involving the cancellation of an existing approval that was granted:

   (a)  following an application of the kind mentioned in item 131 or 132 of Schedule 1; or

  (b)  following an application of the kind mentioned in item 114 of Schedule 1 to the National Health (Australian Community Pharmacy Authority Rules) Determination 2006 (No. PB 23 of 2006); or

   (c)  following a recommendation by the Authority:

         (i)   under paragraph 5 (b) of the Pharmaceutical Benefits Determination under subsection 99L (1) (No. PB 8 of 2006); or

        (ii)   under paragraph 5 (b) of the Pharmaceutical Benefits Determination under subsection 99L (1) (No. PB 8 of 2000); or

  (d)  following an application of the kind mentioned in Part 1 of Schedule 1 that involved the cancellation of an existing approval that was granted in a circumstance mentioned in paragraph (a), (b) or (c); or

   (e)  following an application of the kind mentioned in Part 1 of Schedule 1 to the National Health (Australian Community Pharmacy Authority Rules) Determination 2006 (No. PB 23 of 2006) that involved the cancellation of an existing approval that was granted in a circumstance mentioned in paragraph (b) or (c); or

   (f)  following a recommendation by the Authority under section 6 or 7, and in accordance with section 9, of the Pharmaceutical Benefits Determination under subsection 99L (1) (No. PB 8 of 2006) that involved the cancellation of an existing approval that was granted in a circumstance mentioned in subparagraph (c) (i) or (ii); or

The proposed premises are in the same town as the existing premises.

 

   (g)  following a recommendation by the Authority under section 6 or 7, and in accordance with section 9, of the Pharmaceutical Benefits Determination under subsection 99L (1) (No. PB 8 of 2000) that involved the cancellation of an existing approval that was granted in the circumstance mentioned in subparagraph (c) (ii); or

  (h)  following an application:

         (i)   of the kind mentioned in subsection 90 (3AA) or (3AE) of the Act; and

        (ii)   that involved the cancellation of an approval that was granted in a circumstance mentioned in paragraph (a), (b), (c), (d), (e), (f) or (g).

 

316

An application:

   (a)  involving the cancellation of an existing approval that was granted:

         (i)   following an application of the kind mentioned in item 133 or 134 of Schedule 1; or

        (ii)   following an application:

               (A)    of the kind mentioned in subsection 90 (3AA) or (3AE) of the Act; and

               (B)     that involved the cancellation of an approval that was granted in the circumstances mentioned in subparagraph (i); and

  (b)  that is made within 10 years after the day on which the approval granted in the circumstances mentioned in subparagraph (a) (i) was granted.

The Authority is satisfied that there are exceptional circumstances.

317

An application involving the cancellation of an existing approval that was granted:

   (a)  following an application of the kind mentioned in item 135 or 136 of Schedule 1; or

  (b)  following an application:

        (i)   of the kind mentioned in subsection 90 (3AA) or (3AE) of the Act; and

        (ii)   that involved the cancellation of an approval that was granted in a circumstance mentioned in paragraph (a).

The proposed premises are in the same facility in relation to which the existing approval was granted unless the Authority is satisfied that there are exceptional circumstances.


Note

1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.