(1) This instrument is the National Health (Australian Community Pharmacy Authority Rules) Determination 2018.

(2) This instrument may also be cited as Determination No. PB 46 of 2018.

(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	3 October 2018.	3 October 2018

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under section 99L of the National Health Act 1953.

4 Schedules

Each instrument that is specified in Schedule 3 to this instrument is amended or repealed as set out in the applicable items in that Schedule, and any other item in that Schedule has effect according to its terms.

5 Definitions

Note 1: A number of expressions used in this instrument are defined in the Act, including the following:

(a) pharmacist;

(b) premises;

Note 2: For the definition of medical practitioner and private hospital, see subsection 4(1A) of the Act and subsection 3(1) of the Health Insurance Act 1973.

In this instrument:

Act means the National Health Act 1953.

all relevant times, in relation to an application, means:

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

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

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

Note: This instrument divides applications for approvals in relation to proposed premises into 2 kinds:

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

(b) 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).

Authority has the same meaning as in Part VII of the Act.

commercial establishment has the meaning given by section 7.

designated complex means:

(a) a small shopping centre; or

(b) a large shopping centre; or

(d) a large private hospital.

existing approval has the meaning given by subsection 10(1).

existing premises has the meaning given by subsection 10(1).

full‑time means:

(a) for a prescribing medical practitioner—providing the services of a prescribing medical practitioner for 38 hours in a week; or

(b) for a PBS prescriber—providing the services of a PBS prescriber for 38 hours in a week.

gross leasable area means:

(a) for a group of shops and associated facilities—the total floor area of the group, excluding loading docks and car parks; or

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

Note: Paragraph (a) of this definition is relevant to large shopping centres and small shopping centres, which are groups of shops and associated facilities that meet certain conditions (see the definitions of large shopping centre and small shopping centre in this section).

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 of the hours each week that the medical centre operates.

large private hospital means a private hospital that can admit at least 150 patients at any one time in accordance with the private hospital’s licence or registration under the law of the State or Territory in which the private hospital is located.

large shopping centre means a group of shops and associated facilities that:

(a) is under single management; and

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

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

(e) has customer parking facilities.

PBS prescriber has the same meaning as in Part VII of the Act.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

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 the medical practitioner practises, including the issuing of prescriptions for pharmaceutical benefits.

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

same town:

(a) in relation to approved premises—proposed premises are in the same town as approved premises if the proposed premises are in the same town and postcode area as the approved premises; and

(b) in relation to existing premises—proposed premises are in the same town as existing premises if the proposed premises are in the same town and postcode area as the existing premises.

single management, for a small shopping centre, a large shopping centre or a large medical centre:

(a) means an arrangement in which a single entity, or 2 or more entities working cooperatively under an agreement, are responsible for marketing, maintenance and administration for the centre as a whole; 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 paragraph (a) in relation to the building or centre.

small shopping centre means a group of shops and associated facilities that:

(a) is under single management; and

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

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

(e) has customer parking facilities.

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

6 Meaning of approved premises

(1) In this instrument, approved premises are premises (other than premises that are redundant under subsection (2)) in relation to which:

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

(b) the Authority has recommended an applicant be approved under section 90 of the Act and the Secretary has not yet made a decision on the application.

(2) For the purposes of subsection (1), 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 and the Secretary has not yet made a decision on the application;

(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 the Act, references to an approval granted under section 90 of the Act may include references to other approvals treated as having been granted under section 90. For example, see subsection 91(7) of the Act.

(3) Despite paragraph (1)(b), if:

(a) premises relate to an application made by an applicant under Part 1 of Schedule 1; and

(b) the Authority has recommended the applicant be approved under section 90 of the Act;

the premises are taken not to be approved premises for the purposes of items 132, 134 and 134A of Part 2 of Schedule 1.

7 Meaning of commercial establishment

(1) In this instrument, subject to subsection (2), commercial establishment means premises that are occupied by, or likely to be occupied by:

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

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

(2) For the purposes of 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 childcare centre or child minding facility, unless the centre or facility is available exclusively for use by customers of the small shopping centre or the large shopping centre while the customers are at the small shopping centre or the large 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 for the purposes of identifying a small shopping centre or a large shopping centre or for the purposes of determining whether item 134A of Part 2 of Schedule 1 applies:

(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 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 instrument, 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 instrument, 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 applicant be approved

Applications involving the cancellation of an existing approval

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

(a) the application is of a kind mentioned in column 1 of an item in Part 1 of Schedule 1; and

(b) the following requirements are met in relation to the application:

(i) the requirements in column 2 of that item;

(ii) the requirements in subsection (3);

(iii) the requirements in Part 1 of Schedule 2;

(iv) if a minimum gross leasable area of a group of shops and associated facilities, or of a supermarket, is relevant—the requirements in subsection (4);

(v) if the application is of a kind mentioned in column 1 of an item of Part 2 of Schedule 2—the requirement in column 2 of that item.

Note: For example, for the purposes of subparagraph (1)(b)(iv), minimum gross leasable area is relevant to an application for proposed premises in a large shopping centre. This is because the definition of large shopping centre requires the group of shops and associated facilities to have a gross leasable area of at least 5,000 m2 and contain a supermarket that has a gross leasable area of at least 2,500 m2.

Applications not involving the cancellation of an existing approval

(2) For an application that does not involve the cancellation of an existing approval, the Authority must recommend that an applicant be approved under section 90 of the Act in relation to particular premises if:

(a) the application is of a kind mentioned in column 1 of an item in Part 2 of Schedule 1; and

(b) the following requirements are met in relation to the application:

(i) the requirements in column 2 of that item;

(ii) the requirements in subsection (3).

General requirements

(3) For the purposes of subparagraphs (1)(b)(ii) and (2)(b)(ii), the requirements are that the Authority is satisfied that:

(a) at all relevant times the proposed premises are not approved premises; and

(b) the applicant has, at all relevant times, a legal right to occupy the proposed premises (whether the right is to occupy the premises on the day the application is made or after that day); and

(c) at all relevant times the proposed premises could be used for the operation of a pharmacy under applicable local government and State or Territory laws relating to land development; and

(d) the proposed premises would be accessible by the public; and

(e) 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

(f) the proposed premises will not be directly accessible by the public from within a supermarket.

Note: The requirement in paragraph (3)(c) 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 needed to satisfy this requirement. However, it may be needed for compliance with the requirement in paragraph (3)(e), depending on the operation of applicable State or Territory land development laws.

Requirements relating to gross leasable area

(4) For the purposes of subparagraph (1)(b)(iv), the requirement is that the Authority is satisfied that the gross leasable area of the group of shops and associated facilities or of the supermarket (as the case requires) is at least the minimum size referred to in that subparagraph.

Note: The requirement in this subsection would be satisfied if, for example, the gross leasable area is evidenced by a development approval from a council or an approval authority, a letter from a town planner or a copy of the lease.

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) a requirement under section 10 of this instrument that applies in relation to the application is not met; or

(b) the application involves the cancellation of an existing approval and that existing approval is subject to a recommendation by the Authority that an applicant be approved under section 90 of the Act.

Part 3—Application, saving and transitional provisions

12 Saving provision relating to the repeal of the National Health (Australian Community Pharmacy Authority Rules) Determination 2011

The National Health (Australian Community Pharmacy Authority Rules) Determination 2011, also known as Determination No. PB 65 of 2011, as in force immediately before 3 October 2018, continues to apply in relation to the consideration by the Authority of an application made before that day.

13 Transitional provision relating to the repeal of the National Health (Australian Community Pharmacy Authority Rules) Determination 2011

(1) This section applies if:

(a) a person makes an application before 3 April 2019 in relation to proposed premises; and

(b) immediately before 3 October 2018 and at all relevant times, the person had a legal right to occupy the proposed premises (whether the right is to occupy the premises immediately before 3 October 2018, on the day the application is made or after that day).

Large shopping centre

(2) This instrument applies in relation to the application as if the reference in paragraph (c) of the definition of large shopping centre in section 5 to 2,500 m2 was instead a reference to 1,000 m2.

Applications involving the cancellation of an existing approval where previous approvals were in force for a continuous period of at least 2 years

(3) If the application involves the cancellation of an existing approval, item 312 of Part 1 of Schedule 2 applies in relation to the application as if the requirement in paragraph (a) of that item for one or more approvals in relation to the existing premises to have been in force for a continuous period of at least 5 years was instead a requirement for one or more approvals to have been in force for a continuous period of at least 2 years.

Schedule 1—Application kinds and requirements

Note: See section 10.

Part 1—Applications involving cancellation of existing approval

Applications involving cancellation of existing approval
Item	Column 1 Application kind	Column 2 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 designated complex	The proposed premises are in the same designated complex as the existing premises
123	Relocation within the same town (10 km)	(a) the proposed premises are in the same town as the existing premises; and (b) 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	Relocation up to 1 km	(a) the proposed premises are no more than 1 km, in a straight line, from the existing premises; and (b) one of the following applies: (i) the existing premises are not in a designated complex; (ii) the existing premises are in a large shopping centre and the proposed premises are at least 300 m, in a straight line, from all approved premises not in the large shopping centre; (iii) the existing premises are in a small shopping centre, a large medical centre or a large private hospital and the proposed premises are at least 500 m, in a straight line, from all approved premises not in the small shopping centre, large medical centre or large private hospital
125	Relocation of 1 to 1.5 km	(a) the proposed premises are more than 1 km, but no more than 1.5 km, in a straight line, from the existing premises; and (b) one of the following applies: (i) the existing premises are not in a designated complex and the proposed premises are at least 300 m, in a straight line, from the nearest approved premises; (ii) the existing premises are in a large shopping centre and the proposed premises are at least 300 m, in a straight line, from the nearest approved premises; (iii) the existing premises are in a small shopping centre, a large medical centre or a large private hospital and the proposed premises are at least 500 m, in a straight line, from the nearest approved premises

Part 2—Applications not involving cancellation of existing approval

Applications not involving cancellation of existing approval
Item	Column 1 Application kind	Column 2 Requirements
130	New pharmacy (at least 1.5 km)	(a) the proposed premises are at least 1.5 km, in a straight line, from the nearest approved premises; and (b) the Authority is satisfied that, at all relevant times, there is, within 500 m, in a straight line, from the proposed premises, either: (i) both the equivalent of at least one full‑time prescribing medical practitioner and a supermarket that has a gross leasable area of at least 1,000 m2; or (ii) a supermarket that has a gross leasable area of at least 2,500 m2
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)	(a) the proposed premises are: (i) in the same town as an approved premises; and (ii) at least 200 m, in a straight line, from the nearest approved premises; and (iii) at least 10 km, by the shortest lawful access route, from any approved premises other than the approved premises mentioned in subparagraph (ii); and (b) the Authority is satisfied that, at all relevant times, in the same town as the proposed premises are: (i) the equivalent of at least 4 full‑time prescribing medical practitioners practising; and (ii) one or 2 supermarkets that have a combined total gross leasable area of at least 2,500 m2
133	New pharmacy in a designated complex (small shopping centre)	The proposed premises: (a) are in a small shopping centre; and (b) are at least 500 m, in a straight line, from the nearest approved premises, other than approved premises in a large shopping centre or private hospital; and (c) there are no approved premises in the small shopping centre
134	New pharmacy in a designated complex (large shopping centre with no approved premises)	(a) the proposed premises are in a large shopping centre; and (b) there are no approved premises in the large shopping centre
134A	New additional pharmacy in a designated complex (large shopping centre with approved premises)	(a) the proposed premises are in a large shopping centre; and (b) if the large shopping centre contains: (i) at least 100, but fewer than 200, commercial establishments—there is only one approved premises in the large shopping centre; or (ii) at least 200 commercial establishments—there are at least one but no more than 2 approved premises in the large shopping centre; and (c) no approved premises have relocated out of the large shopping centre in the 12 months immediately before the day the application was made
135	New pharmacy in a designated complex (large private hospital)	(a) the proposed premises are in a large private hospital; and (b) there are no approved premises in the large private hospital
136	New pharmacy in a designated complex (large medical centre)	(a) the proposed premises are in a large medical centre; and (b) there are no approved premises in the large medical centre; and (c) if the large medical centre is: (i) in a small shopping centre, a large shopping centre or a private hospital—the proposed premises are at least 300 m, in a straight line, from any approved premises, other than approved premises in a different large shopping centre or private hospital; or (ii) not in a small shopping centre, a large shopping centre or a private hospital—the proposed premises are at least 300 m, in a straight line, from the nearest approved premises, other than an approved premises in a large shopping centre or private hospital; and (d) the Authority is satisfied that, during the 2 months before the day on which the application is made and until the day the application is considered by the Authority, 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; and (e) 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—Requirements for applications involving cancellation of existing approval

Note: See section 10.

Part 1—Requirements for all applications involving cancellation of existing approval

Requirements for applications involving cancellation of existing approval—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) one or more approvals in relation to the existing premises were in force, immediately before the day the application was made, for a continuous period of at least 5 years; or (b) if paragraph (a) does not apply: (i) the application is of the kind mentioned in item 122 of Part 1 of Schedule 1; or (ii) the application is of the kind mentioned in item 123 of Part 1 of Schedule 1; 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 and the application is not of the kind mentioned in item 125 of Part 1 of Schedule 1; 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 and the application is not of the kind mentioned in item 125 of Part 1 of Schedule 1; or (v) because of a disaster or exceptional circumstances pharmaceutical benefits are unable to be supplied at the existing premises, and will not be able to be supplied at the existing premises in the future, and the application is not of the kind mentioned in item 125 of Part 1 of Schedule 1; or (vi) both of the following apply: (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; (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 5 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—Requirements for certain kinds of applications involving cancellation of existing approval

Requirements for applications involving cancellation of existing approval—particular applications
Item	Column 1 Description of application	Column 2 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 Part 2 of Schedule 1; or (ii) following an application of a kind mentioned in subsection 90(3AA) or (3AE) of the Act that involved the cancellation of an approval that was granted in the circumstances mentioned in subparagraph (i); or (iii) following an application of a kind mentioned in Part 1 of Schedule 1 that involved the cancellation of an existing approval that was granted following an application of a 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 circumstances 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)
314	An application involving the cancellation of an existing approval that was granted: (a) following an application of a kind mentioned in item 131 or 132 of Part 2 of Schedule 1; or (b) following an application of the kind mentioned in item 114 of Part 2 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 2000); or (ii) under paragraph 5(b) of the Pharmaceutical Benefits Determination under subsection 99L (1) (No. PB 8 of 2006); or (d) following an application of a 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) of this item; or (e) following an application of a 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) of this item; or (f) following a recommendation by the Authority under paragraph 6 or 7, and in accordance with paragraph 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) of this item; or (g) following a recommendation by the Authority under paragraph 6 or 7, and in accordance with paragraph 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) of this item; or (h) following an application: (i) that was of a 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) of this item	The proposed premises are in the same town as the existing premises
315	An application: (a) involving the cancellation of an existing approval that was granted: (i) following an application of a kind mentioned in item 133, 134 or 134A of Part 2 of Schedule 1; or (ii) following an application: (A) that was of a 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
316	An application involving the cancellation of an existing approval that was granted: (a) following an application of a kind mentioned in item 135 or 136 of Part 2 of Schedule 1; or (b) following an application: (i) that was of a 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 designated complex in relation to which the existing approval was granted unless the Authority is satisfied that there are exceptional circumstances