[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]
Street address of business premises:
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
Have you ever been declined, or had revoked, a licence to manufacture, pack, sell, or hawk medicines? Yes/No
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.]
The body corporate is incorporated in New Zealand Yes/No
Street address of body corporate:
General nature of business of body corporate:
Name of person completing this form: [surname] [first names]
Position in body corporate of person completing form:
Name | Date of birth | Position in body corporate |
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Have any of the above nominees ever been declined, or had revoked, a licence to manufacture, pack, sell, or hawk medicines? Yes/No
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
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:
(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 designation | Trade name of medicine | Class |
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Premises where manufacture (including packing and labelling) of the medicines will be carried out:
Signature of applicant (or Common Seal where applicant is a body corporate):
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 designation | Trade name of medicine | Class |
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Premises where packing and labelling will be carried out:
Signature of applicant (or Common Seal where applicant is a body corporate):
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:
Signature of applicant (or Common Seal where applicant is a body corporate):
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:
Signature of applicant (or Common Seal where applicant is a body corporate):
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:
Signature of applicant (or Common Seal where applicant is a body corporate):
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).