Pharmacy Ownership

Question 1

MA 5A

Answer 1

Meaning of holding an interest in a pharmacy

1) person who acquires any direct or indirect estate that affects the ownership or control of a pharmacy practice carried on in the pharmacy
2) acquisition is made in the persons name

3)
a- a person does not hold an interest in a pharmacy by
i-in good faith carrying on the pharmacy, any loan of money
ii-holding any security for repayment of that loan

Question 2

MA 5B

Answer 2

Meaning of operating a pharmacy

a- established or carries on business
b-responsible for the management or control of hospital pharmacy
c- responsible for the management or control of a pharmacy, on a not for profit basis

Question 3

MA 42A

Answer 3

Every pharmacy must be under supervision of a pharmacist

No person may operate any pharmacy that is not for the time being under immediate supervision or control of a pharmacist

Question 4

MA 47

Answer 4

Storage and delivery of medicines

1) No person shall put any prescription or restricted medicine
a- in a cupboard, box or shelf or other place that food or drink are stored
b-in a place where young children or unauthorised persons have ready access to

2) No packing or preparing any medicine for use in any room or tablet or bench that is used for the purpose of preparing or consuming food
3) Keep medicines in a building or vehicle, shall leave that building or vehicle unless taken all reasonable steps to secure it from unlawful entry
4) No person shall deliver on retail sale other than through post or by handing it to person or person’s behalf

Question 5

MA 17

Answer 5

Manufacturers, wholesalers to be licensed

NO person shall 
a- manufacture med
b- sell med by wholesale
c-pack or label any med
d-operate any pharmacy 

if they do not have a lisence

Question 6

MA 50

Answer 6

Application for licenses

1- made in prescribed form to the DG
2- shall contain all information documents samples and other materials required + prescribed fee
3- indicate the descriptions of medicines sought
4- Made by NZ resident on behalf of person or by appropriate body corporate

Question 7

MA 51

Answer 7

Grant of licenses

if he is satisfied in respect of the following matters
1
a- complied with section 50
b- person is fir and proper or body corporate has good repute
c- no subject to any disqualification
d-responsible person has sufficient knowledge of obligations of licensee and hazards of medicines proposed to deal
e- equipment and premises are suitable and adequate for purpose sought in license
f- adequate arrangements have been made to maintain and safekeep adequate records in respect of med manufactures, stored, packed and labelled

3- authority shall not decline application without giving opportunity for person to be heard

4- license can be subject to conditions

5-License to sell medicine may be combined with license to pack that medicine

6-Failure to comply with conditions on license
a-suspend license for reasonable period
b-reasonable opportunity to be heard

Question 8

MA 52

Answer 8

Effect of licenses

1) License…
a- to manufacture medicines shall authorize manufacture, packing and labelling and sale by wholesale of medicines described in license
b- to pack medicines shall authorize packing and labelling and sale by wholesale
c- to sell medicines by retail shall authorize sale by retail and supply according to retail sale
d-license to operate a pharmacy authorises the establishment of pharmacy and the carrying on of pharmacy practice

2) A license to sell medicines by retail sale does not include retail sale of any prescription medicines or restricted medicines

Question 9

MA 53

Answer 9

Duration of licenses

1) continues for a year and then expires
2) Any license issued within a period of 2 months preceding the date of expiration of an existing license that is intended to supersede shall continue in force for a period of 1 year beginning on that date
3) If licensee had applied for a new license not more than 3 months and not less than 1 month before the date of expiration of an existing license and that application is not disposed of before date, the existing license shall continue to be in force until application is disposed of

Question 10

MA 54

Answer 10

Display of licenses

1) readily sen by all persons having access to the premises to which the license relates to
2) if authorised to sell medicines elsewhere than regular business, shall produce his license for inspection when required by officer or unable to then should produce it at the office of licensing authority within 24 hours

Question 11

MA 55A

Answer 11

Additional criteria to be satisfied by pharmacy operators

55D
55E
55G

55C

Question 12

MA 55B

Answer 12

Licensing authority may require further information

1- may require an applicant to supply additional information for purposes stated in 2

2-
a-determine nature of interest
b-individual is fit and proper or body corporate in good repute
c- assessment in 55A(1)

3- fails to supply information within 30 days, the application lapses

Question 13

MA 55C

Answer 13

Mandatory condition of license to operate pharmacy

Holder of license must not request or require any pharmacist who is employed or engaged in duties at a pharmacy act in a way that is inconsistent with the applicable professional or ethical standards of pharmacy practice

Question 14

MA 45A

Answer 14

Application for license to operate a pharmacy

1) Every application must -
a- be made in form of 1A Schedule 2
- in form of 1B Schedule 2

b
be accompanied by
i- appropriate fee
ii-completed statutory declaration

2- granted in respect of 1 place of business

3-Every applicant must provide the following if required by authority
a-further information
b-opportunity to inspect premises and equipment

3- In order to determine whether person has sufficient knowledge of the obligations of a licensee and hazards associated with medicines, authority may require person to undertake and pass any oral or written assessments that are reasonable

Question 15

MA 46

Answer 15

Forms and conditions of license

a-manufacture medicines form2 schedule 2
b-hawk medicines form 3 schedule 2
c- sell medicines by wholesale form 4 schedule 2
d-sell medicines by retail form 5 schedule 2
e-pack medicines form 6 schedule 2
f- operate pharmacy form 7 schedule 2

Question 16

MA 48A

Answer 16

Licensing authority to be advised of change in particulars relating to operating a pharmacy

1) as soon as practicable of any changes in detail that relate to application of license this includes any additional information required by authority
2) If a company is granted under 55D(2a) must advise authority of ownership changes or changes where there is more than 50% of shale that is no longer owned by a pharmacist (s)

Question 17

MA 49

Answer 17

Surrender of license

1) in subclause 1A this refers to licenses that
a-manufacture, hawk, sell or pack any medicines
b-operate a pharmacy

1A) within 7 days of ceasing to undertake activity must surrender that license

2) Authority shall retain license for the remainder of the current license period
3) Nothing in this regulation shall prevent person from applying for restoration of license
4) if satisfied with licensee complying to requirements of this act, license shall be restored
5) Shall not be necessary to pay a further fee for restoration

Question 18

MA 42C

Answer 18

Restriction on authorised prescriber holding an interest in pharmacies

1- no authorised prescriber may hold interest in a pharmacy exccept with consent from licensing authority

2-No person who has an interest in a pharmacy may permit or enable any authorised prescriber to hold or acquire that or any other interest in the pharmacy

3- Licensing authority can only give consent for an authorised prescriber if satisfied that there are sufficientsafeguards to prevent the issue of prescriptions form being influenced by commercial or financial interests of prescriber

Question 19

MA 55D

Answer 19

Restriction on companies operating pharmacies

1) no company may be granted a license to operate a pharmacy unless subsection 2a-e apply

2)A company may be granted a license if
a-at all times more than 50% of the share capital of the company is owned by a pharmacist(s) and effective control is vested in that pharmacist(s)
b- exempt from requirements by 105C
c-it is deemed to have been issued by 114A(2)
d- pharmacy is in a hospital owned and operated
e- before this act, was lawfully operating a pharmacy

4) pharmacist includes an administrator of the estate of a deceased pharmacists until
a- expiry of ther period of 1 year after the date of death of deceased pharmacist

Question 20

MA 55E

Answer 20

Restriction on individuals operating or holding majority interest on pharmacies

1- no person may be granted a license to operate a pharmacy or hold majority interest in a pharmacy unless
a- person is a pharmacist
b-exempt from requirements by 105C
c- license issued under 114A(2)
d- pharmacy is hospital owned
e- before this act the person was lawfully operating a pharmacy

Question 21

MA 55F

Answer 21

Prohibition on operating or holding of majority interest in more than 5 pharmacies

1
a- no company can operate more than 5 pharmacies
b- No person or pharmacist may operate or hold interest in more than 5 pharmacies

Question 22

MA 55G

Answer 22

Exemption for mortgagees in possession

1- mortgagee in possession of a pharmacy may be granted a license to operate a pharmacy for a period of 3 months which can be extended for authority