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Medicines Act 1981

Related products

96: Certain provisions to apply to related products as if medicines

You could also call this:

"Rules for related products that are like medicines"

Illustration for Medicines Act 1981

You need to follow some rules when related products are like medicines. When a new related product is made, some parts of the law, like sections 20 to 22 and 35, apply to it in the same way as they apply to new medicines. These laws help keep you safe. Some other parts of the law, like section 24, also apply to related products when they are changed in some way. These changes can affect how well the related product works for a therapeutic purpose, which is a purpose related to treating or preventing a disease. The laws also apply to how the related product is used, labelled, or described for a therapeutic purpose. More parts of the law, like sections 37, 40, and 44, apply to related products in the same way as they apply to medicines. These laws help control related products and keep you safe. Some powers given to authorities, like those in section 105, can also be used for related products to keep you safe.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM56502.

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Health and wellbeing > Public healthHealth and wellbeing > Healthcare services
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95: Application of Act to related products, or

"When the Medicines Act applies to related products"

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96A: Interpretation, or

"What special words mean in this law"

Part 7Related products

96Certain provisions to apply to related products as if medicines

  1. Sections 20 to 22, and 35, with all necessary modifications, shall apply to new related products in the same manner and to the same extent as they apply to new medicines.

  2. Subsections (1) and (2) of section 24 shall apply to every material change made in respect of a related product in the same manner and to the same extent as they apply to material changes in respect of medicines, subject to the following modifications:

  3. the reference in subsection (1) to the efficacy of the medicine shall be read as a reference only to the efficacy of the related product for a therapeutic purpose:
    1. subsection (2)(a) shall be read as applying only to the recommended dosage or the recommended manner of administration or use for a therapeutic purpose:
      1. subsection (2)(b) shall be read as applying only to any labelling or descriptive matter relating to a therapeutic purpose:
        1. subsection (2)(c) and subsection (2)(d) shall be read as applying only to a material change that is relevant to a therapeutic purpose.

          1. Subsections (3) to (6) of section 24, and sections 37, 40, and 44, Parts 4 and 5 (except section 83), Part 6, and sections 98 and 107, with all necessary modifications, shall apply to related products in the same manner and to the same extent as they apply to medicines.

          2. All or any of the powers conferred by paragraphs (f), (g), (h), (i), (k), (l), and (y) of subsection (1) of section 105 may be exercised in respect of related products, and the powers conferred by paragraph (k) of that subsection may be exercised in respect of any ingredient of any related product, as they may be exercised in respect of medicines; and for this purpose subsections (2) to (4) of that section shall, so far as they are applicable, apply in respect of related products and ingredients of related products and kinds of related products as they apply in respect of medicines and descriptions of medicines.