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Medicines Act 1981

Provisions relating to licences

50: Applications for licences

You could also call this:

"How to Apply for a Medicine Licence"

Illustration for Medicines Act 1981

To apply for a licence, you must fill out the correct form and give it to the Director-General or someone they choose. You need to include certain information, documents, and samples with your application, and you must pay the required fee. The application must say what medicines you want a licence for, either by listing them or by using a general category. You can apply for a licence on your own if you live in New Zealand, or a company can apply if it is incorporated in New Zealand. A company must have an appropriate officer make the application on its behalf. If your application is complete and correct, it will be sent to the licensing authority to be considered.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55494.

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Part 3Provisions relating to licences

50Applications for licences

  1. Every application for a licence must be made in the prescribed form to the Director-General or to any person designated for the purpose by the Director-General by notice in the Gazette.

  2. Every such application shall contain or be accompanied by such particulars, information, documents, samples, and other material as may be prescribed, and shall be accompanied by the prescribed fee.

  3. The application shall indicate the descriptions of the medicines in respect of which the licence is sought, either by specifying those descriptions, or by reference to an appropriate general classification.

  4. An application may be made either by an individual who is a New Zealand resident on the person's own behalf or by an appropriate officer of a body corporate that is incorporated in New Zealand on behalf of that body corporate.

  5. If a person authorised to receive an application under subsection (1) is satisfied that an application complies with the requirements of this section and of any regulations made under this Act that are applicable to the application, the person must refer the application to the licensing authority.

Compare
  • 1960 No 97 s 15
  • 1979 No 27 s 35
  • Medicines Act 1968 s 18 (UK)
Notes
  • Section 50(1): substituted, on , by section 13(1) of the Medicines Amendment Act 2003 (2003 No 50).
  • Section 50(4): substituted, on , by section 13(2) of the Medicines Amendment Act 2003 (2003 No 50).
  • Section 50(5): substituted, on , by section 13(2) of the Medicines Amendment Act 2003 (2003 No 50).