Medicines Regulations 1984

Schedule 2

Form 1 Application for licence to manufacture, hawk, sell, or pack medicine

[Before completing this form you should make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, especially those parts that deal with licences.

This form may be used to apply for licences to manufacture, pack, sell, or hawk medicines. It is divided into 7 parts. Every applicant must complete either Part 1 or Part 2, and must also complete at least one of Parts 3, 4, 5, 6, and 7.

Every application must be accompanied by the prescribed fee for each licence applied for (viz, regulation 61, Medicines Regulations 1984).]

The form must be completed in type, or in block capitals.

Part 1

[To be completed where the applicant is an individual applying for a licence on his own behalf.]

Name of applicant: [surname] [first names]

I am a New Zealand resident: Yes/No

Date of birth: [day/month/year]

Address (home):

Name of business:

Street address of business premises:

 
 

Postal address:

General nature of business:

Position of applicant (for example, “owner”, “manager” etc):

 
 

Have you previously held a licence to manufacture, pack, sell, or hawk medicines? Yes/No

If yes give details:

 
 

Have you ever been declined, or had revoked, a licence to manufacture, pack, sell, or hawk medicines? Yes/No

If yes give details:

 
 

Part 2

[To be completed where the applicant is an officer of a body corporate applying for a licence on behalf of the body corporate.]

Name of body corporate:

The body corporate is incorporated in New Zealand Yes/No

Street address of body corporate:

 
 

Postal address:

General nature of business of body corporate:

 

Name of person completing this form: [surname] [first names]

 
 

Position in body corporate of person completing form:

 

Details of persons nominated to be responsible persons under the Medicines Act 1981:

NameDate of birthPosition in body corporate
 
 

Have any of the above nominees ever been declined, or had revoked, a licence to manufacture, pack, sell, or hawk medicines? Yes/No

If yes give details:

 
 

Have any of the above nominees ever been a licensee or responsible person under the Restricted Drugs Act 1960 or the Medicines Act 1981? Yes/No

If yes give details:

 
 

Part 3

Application to manufacture medicines

I hereby make application for a licence to manufacture the medicines listed below (attach extra list if insufficient space provided here). Indicate (by reference to one of the following paragraphs) which of the following classes the medicines come within:

(a)

antibiotics, or preparations of antibiotics:

(b)

vaccines and sera:

(c)

sterile preparations:

(d)

hormones and steroid preparations:

(e)

preparations, other than vitamins, having a dose of 5 milligrams or less per unit dose:

(f)

antineoplastic agents and immunosuppressant agents other than steroid preparations:

(g)

other medicines not included in paragraphs (a) to (f), above.

Appropriate designationTrade name of medicineClass
 
 
 
 
 
 

Premises where manufacture (including packing and labelling) of the medicines will be carried out:

 

I enclose the fee of:

 

Signature of applicant (or Common Seal where applicant is a body corporate):

Date:

Part 4

Application to pack medicines

I hereby make application for a licence to pack the medicines listed below (attach extra list if insufficient space provided here). Indicate in the third column whether the medicine is a prescription medicine, restricted medicine, or pharmacy-only medicine.

Appropriate designationTrade name of medicineClass
 
 
 
 
 
 

Premises where packing and labelling will be carried out:

 
 

I enclose the fee of:

Signature of applicant (or Common Seal where applicant is a body corporate):

Date:

Part 5

Application to sell medicines by wholesale

I hereby make application to sell by wholesale the following medicines (attach extra list if insufficient space provided here):

 
 
 
 
 

Premises from where medicines are to be sold:

 
 

I enclose the fee of:

Signature of applicant (or Common Seal where applicant is a body corporate):

Date:

Part 6

Application to sell medicines by retail

I hereby make application to sell by retail the following medicines (attach extra list if insufficient space provided here):

 
 
 
 
 

Premises from where medicines are to be sold:

 
 

I declare the above premises are more than 10 kilometres by road from the nearest pharmacy.

The reasons for this application are:

 
 
 
 
 

I enclose the fee of:

Signature of applicant (or Common Seal where applicant is a body corporate):

Date:

Part 7

Application to hawk medicines

I hereby make application for a licence to hawk medicines.

Premises where stock of medicines will be kept:

 
 

Place where records of sale of medicines will be kept:

 
 

Geographical area in which it is proposed to hawk medicines:

 
 

Persons or classes of persons to whom it is proposed to hawk medicines:

 
 

Name and maximum quantity of medicines intended to be transported when hawking:

 
 

I enclose the fee of:

Signature of applicant (or Common Seal where applicant is a body corporate):

Date:

Schedule 2 form 1 heading: substituted, on 18 September 2004, by regulation 9(1)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 1 Part 1: amended, on 18 September 2004, by regulation 9(1)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 1 Part 2: amended, on 18 September 2004, by regulation 9(1)(c) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 1A Application for licence to operate pharmacy made (by employee or agent) on behalf of company

r 45A(1)(a)(i)

Important information

Before filling out this application please note the following important information:

  • this form may be used by an employee or agent who is making an application on behalf of a company:

  • you must make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, in particular those provisions relating to licensing and operating pharmacies:

  • the following must accompany this application:

    • the prescribed fee:

    • a completed statutory declaration:

  • it is an offence to make a false statutory declaration:

  • the licensing authority may require you to supply additional information at a later date (see section 55B of the Medicines Act 1981). If you do not supply that information within 30 days of the request, this application will lapse.

Please complete the following:

Applicant and company

I, [full name of employee or agent of company], [position in company], make this application for a licence to operate a pharmacy on behalf of [name of company], which—

(a)

was incorporated in New Zealand on [date of incorporation]; and

(b)

has the following board members:

[full names of all board members].

The address of the company is [address].

The following persons are nominated to be responsible persons for the purposes of the licence under the Medicines Act 1981:

[full names, dates of birth, and positions held].

Street address and description of pharmacy

The street address of the pharmacy to which this application relates is [street address].

The pharmacy will comprise the following part or parts of that street address: [specify the part or parts of the street address that are to be a pharmacy or attach a line drawing showing the part or parts].

Interests held in pharmacy

Note: Before filling out this part of the form please read section 5A of the Medicines Act 1981, which sets out the meaning of holding an interest in a pharmacy.

The following person(s) or company (or companies) hold an interest in the pharmacy (as defined in section 5A of the Medicines Act 1981) to which this application relates: [name(s) of person(s) or company (or companies), their address(es), and the particulars of the interest held (or “none” if applicable)].

The following person(s) who hold an interest in the pharmacy to which this applicaton relates is a (or are) practioner(s) (or registered midwife (midwives)) (or designated prescriber(s)): [name of the interest holder(s) and his or her relevant position (or “none” if applicable)].

Eligibility to hold licence

*The share capital of the company is more than 50% owned by [full name of pharmacist] who is a pharmacist† (or [full names of pharmacists] who are pharmacists) and effective control of the company is vested in the above-named pharmacist (or pharmacists).

†In this context, a pharmacist
(a)

means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy; and

(b)

includes an administrator of the estate of a deceased pharmacist, and an assignee within the meaning of the Insolvency Act 1967 of the estate of a pharmacist, until—

(i)

the expiry of the period of 1 year after the date of the death of the deceased pharmacist, or the date on which the pharmacist was adjudicated bankrupt; or

 

or

(ii)

subject to any conditions that the licensing authority proposes, the extended period or periods permitted by the licensing authority.

or

*The pharmacy to which this application relates is in a hospital owned or operated by the company. [Specify details.]

or

*[Specify other ground in section 55D(2) of the Medicines Act 1981 that makes the company eligible to hold a licence.]

*Delete if inapplicable.

Practices and procedures for pharmacists working in pharmacy

The following practices and procedures will be in place to ensure that any pharmacist* who is employed or engaged in duties in the pharmacy to which this application relates is not requested or required to act in a way that is inconsistent with the applicable professional or ethical standards of the pharmacy practice: [specify relevant practices and procedures].

*In this context, a pharmacist means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy.

Other pharmacies

The company operates the following pharmacy (or pharmacies): [name(s) and address(es) of pharmacy (or pharmacies) (or "none" if applicable)].

[Specify number, or “none” if applicable] of those pharmacies are (or is) currently for sale.

*Mortgagee in possession

The company is a mortgagee in possession† of the pharmacy to which this application relates.

*Delete if inapplicable.

†For the purposes of this application a mortgagee in possession has the same meaning as in section 4 of the Property Law Act 2007.

Signature of applicant:

Declaration

I, [full name of agent or employee of the company], of [place], [occupation], solemnly and sincerely declare that the statements made in the above application are true and correct.

I make this solemn declaration conscientiously believing the same to be true and by virtue of the Oaths and Declarations Act 1957.

Declared at [place, date] before me:

[Signature]
Justice of the Peace
(or other person authorised to take a statutory declaration)

Schedule 2 form 1A: inserted, on 18 September 2004, by regulation 10 of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 1A: amended, on 1 January 2008, by regulation 4 of the Medicines (Property Law Act 2007) Amendment Regulations 2007 (SR 2007/382).

Form 1B Application for licence to operate pharmacy made by person who is individual (or employee or agent of body corporate that is not company)

r 45A(1)(a)(ii)

Important information

Before filling out this application please note the following important information:

  • this form may be used by—

    • an individual who is applying for a licence to operate a pharmacy; or

    • an employee or agent of a body corporate (other than a company) who is applying for a licence to operate a pharmacy on behalf of that body corporate (for example, an application made on behalf of a partnership or friendly society):

  • you must make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, in particular those provisions relating to licensing and operating pharmacies:

  • the following must accompany this application:

    • the prescribed fee:

    • a completed statutory declaration:

  • it is an offence to make a false statutory declaration:

  • the licensing authority may require you to supply additional information at a later date (see section 55B of the Medicines Act 1981). If you do not supply that information within 30 days of the request, this application will lapse.

Please complete the following:

Application (and body corporate)

I, [full name], of [address], being a resident of New Zealand, apply for a licence to operate a pharmacy on—

*my own behalf.

*on behalf of the body corporate called [name of body corporate], which—

(a)

is not a company, but is a [specify the type of body corporate]; and

(b)

was incorporated in New Zealand on [date]; and

(c)

has the following board members (or trustees) (or partners): [full names of board members (or trustees) (or partners)].

*Delete if inapplicable.

My address (or The address of the body corporate) is [address].

*I was born on [date].

or

*I hold the office of [specify office held] within the above-named body corporate. The following persons are nominated to be responsible persons under the Medicines Act 1981:

[full names, dates of birth, and positions held].

*Delete if inapplicable.
Street address and description of pharmacy

The street address of the pharmacy to which this application relates is [street address].

The pharmacy will comprise the following part or parts of that street address: [specify the part or parts of the street address that are to be a pharmacy or attach a line drawing showing the part or parts].

Interests held in pharmacy

Note: Before filling out this part of the form please read section 5A of the Medicines Act 1981, which sets out the meaning of holding an interest in a pharmacy.

The following person(s) or company (or companies) hold an interest in the pharmacy (as defined in section 5A of the Medicines Act 1981) to which this application relates: [name(s) of person(s) or company (or companies), their address(es), and the particulars of the interest held (or “none” if applicable)].

The following person(s) who hold an interest in the pharmacy to which this applicaton relates is a (or are) practioner(s) (or registered midwife (midwives)) (or designated prescriber(s)): [name of the interest holder(s) and his or her relevant position (or “none” if applicable)].

Eligibility to hold licence

*I am (or [Name of person in body corporate who has the majority interest] is) a pharmacist for the purposes of this application because I am (or he or she is) a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy.

or

*I am (or The body corporate is) a pharmacist because [specify part of the definition of pharmacist in section 55E(3) of the Medicines Act 1981] applies.

or

*The pharmacy I am (or The body corporate is) applying to operate is in a hospital owned or operated by me (or the body corporate).

[Specify details.]

or

*I am (or The body corporate is) eligible to operate a pharmacy because [specify other ground in section 55E(1) of the Medicines Act 1981 that makes person or body corporate eligible to hold a licence].

*Delete if inapplicable.

Practices and procedure for pharmacists working in pharmacy

The following practices and procedures will be in place to ensure that any pharmacist* who is employed or engaged in duties in the pharmacy to which this application relates is not requested or required to act in a way that is inconsistent with the applicable professional or ethical standards of the pharmacy practice: [specify practices and procedures].

*In this context, a pharmacist means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy.

Other pharmacies

I operate (or have a majority interest in) (or The body corporate operates) the following pharmacy (or pharmacies): [name(s) and address(es) of the pharmacy (or pharmacies) (or “none” if applicable).]

[Specify number, or “none” if applicable] of those pharmacies are (or is) currently for sale.

*Mortgagee in possession

I am (or The body corporate is) the mortgagee in possession† of the pharmacy to which this application relates.

*Delete if inapplicable.

†For the purposes of this application a mortgagee in possession has the same meaning as in section 4 of the Property Law Act 2007.

Signature of applicant:

Declaration

I [full name of applicant], of [place], [occupation], solemnly and sincerely declare that the statements made in the above application are true and correct.

I make this solemn declaration conscientiously believing the same to be true and by virtue of the Oaths and Declarations Act 1957.

Declared at [place, date] before me:

[Signature]
Justice of the Peace
(or other person authorised to take a statutory declaration)

Schedule 2 form 1B: inserted, on 18 September 2004, by regulation 10 of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 1B: amended, on 1 August 2011, by regulation 28 of the Medicines Amendment Regulations 2011 (SR 2011/245).

Form 2 Licence to manufacture medicines

(Issued pursuant to the Medicines Act 1981)

Licence No:

Name of licensee:

Address of licensee:

Name of responsible persons:

 
 
 

The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to manufacture, pack, label, and sell by wholesale the following medicines or classes of medicines:

 
 

*Delete whichever does not apply.

The authority granted by this licence is subject to the following conditions:

(1)

The manufacture, packing, labelling, or sale of the medicines shall be carried out in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(2)

[Further conditions imposed by the licensing authority]:

This licence shall expire on [date].

[Signature]
(Licensing authority)

Schedule 2 form 2: amended, on 18 September 2004, by regulation 9(2)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 2: amended, on 18 September 2004, by regulation 9(2)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 3 Licence to hawk medicines

(Issued pursuant to the Medicines Act 1981)

Licence No:

Name of licensee:

Address of licensee:

Names of responsible persons:

 
 
 
 
 

The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to hawk the following medicines:

 
 
 
 

*Delete whichever does not apply.

The authority granted by this licence is subject to the following conditions:

(1)

All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(2)

The stock of medicines held by the licensee or responsible person shall be stored only at the following place or places:

(3)

The records of sale shall be kept at the following premises:

(4)

Sales shall only be made within the following geographical area:

(5)

Sales shall only be made to the following persons or classes of persons:

(6)

[Further conditions imposed by the licensing authority]:

 

This licence shall expire on [date].

[Signature]
(Licensing authority)

Schedule 2 form 3: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 3: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 4 Licence to sell medicines by wholesale

(Issued pursuant to the Medicines Act 1981)

Licence No:

Name of licensee:

Address of licensee:

Name of responsible persons:

 
 
 
 
 

Address of business premises:

 
 

The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to sell by wholesale the following medicines:

 
 
 
 
*Delete whichever does not apply.

The authority granted by this licence is subject to the following conditions:

(1)

The sale of the above medicines shall not take place other than at the business premises set out above.

(2)

All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(3)

[Further conditions imposed by the licensing authority]:

 

This licence shall expire on [date].

[Signature]
(Licensing authority)

Schedule 2 form 4: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 4: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 5 Licence to sell medicines by retail

(Issued pursuant to the Medicines Act 1981)

Licence No:

Name of licensee:

Address of licensee:

Name of responsible persons:

 
 
 
 
 

Address of business premises:

 
 

The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to sell by retail, and supply in circumstances corresponding to retail sale, the following medicines:

 
 
 
 
*Delete whichever does not apply.

The authority granted by this licence is subject to the following conditions:

(1)

The sale of the above medicines shall not take place other than at the business premises set out above.

(2)

All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(3)

[Further conditions imposed by the licensing authority]:

 

This licence shall expire on [date].

[Signature]
(Licensing authority)

Schedule 2 form 5: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 5: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 6 Licence to pack medicines

(Issued pursuant to the Medicines Act 1981)

Licence No:

Name of licensee:

Address of licensee:

Names of responsible persons:

 
 
 
 

Address of business premises:

 
 

The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to pack or label for the purpose of sale, and sell by wholesale the following medicines:

 
 
 
 
 
*Delete whichever does not apply.

The authority granted by this licence is subject to the following conditions:

(1)

The packing, labelling, or sale of the medicines shall be carried out in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(2)

[Further conditions imposed by the licensing authority]:

 
 

This licence shall expire on [date].

[Signature]
(Licensing authority)

Schedule 2 form 6: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 6: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 7 Licence to operate pharmacy

r 46(1)(f)

Section 51, Medicines Act 1981

Licence No:

This licence to operate a pharmacy is granted to [full name of person or body corporate] of [address] and authorises—

  • the establishment of a pharmacy at [location] (or in the following part or parts of [location]: [specify relevant part or parts]); and

  • the carrying on of pharmacy practice in that pharmacy.

*Names of responsible persons for body corporate:

 
 
 
 
 
*Delete if inapplicable.

The pharmacy must be operated in accordance with the duties and obligations in the Medicines Act 1981.

This licence is subject to the following conditions:

(a)

the holder of this licence must not request or require any pharmacist who is employed or engaged in duties at the above-named pharmacy to act in a way that is inconsistent with the applicable professional or ethical standards of pharmacy practice:

(b)

[specify any other conditions].

This licence expires on [date].

[Signature]
(Licensing authority)

Schedule 2 form 7: added, on 18 September 2004, by regulation 11 of the Medicines Amendment Regulations 2004 (SR 2004/300).