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Medicines Act 1981

Schedule 3: Incorporation by reference

You could also call this:

"Incorporation by Reference: Adding Rules from Other Sources into the Medicines Act"

Illustration for Medicines Act 1981

The Medicines Act 1981 has a schedule called Incorporation by Reference. You need to know what this means. When the government wants to include some information in the regulations, they must make it available for you to see. They do this by putting it on their website or in a place where you can go to read it. The government must also tell you where you can find this information and how you can get a copy. If the information is not in a language you understand, they must provide a translation. You can even give your thoughts on the information before it is officially included in the regulations. Once the information is included, it becomes part of the regulations. If the original information is changed, the changed version does not automatically become part of the regulations. The government must officially include the new version in the regulations for it to apply. The Director-General is in charge of making sure you can access this information. They must keep a copy of the information and make it available for you to see. If you need to prove what the information says, the Director-General's copy is the official version. Some laws do not apply to this information just because it is included in the regulations. The government has rules about how they include information in regulations, and these rules do not always apply. You can find more information about these rules in the Legislation Act 2019 and other laws.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM6194412.

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Schedule 2: Enactments repealed, or

"Laws that are no longer valid under the Medicines Act 1981"

3Incorporation by reference Empowered by s 105F(2)

1Requirement to consult on proposal to incorporate material by reference

  1. Before regulations incorporating material by reference in reliance on section 105F are made, the Director-General must—

  2. make copies of the material proposed to be incorporated by reference (the proposed material) available for inspection during working hours for a reasonable period, free of charge, at the head office of the Ministry of Health and any other places that the Director-General may, at his or her discretion, determine are appropriate; and
    1. state where copies of the proposed material are available for purchase; and
      1. make copies of the proposed material available, free of charge, on an Internet site maintained by or on behalf of the Ministry of Health, unless doing so would infringe copyright; and
        1. give notice in the Gazette stating—
          1. that the proposed material is available for inspection during working hours, free of charge, and stating the places at which it can be inspected and the period during which it can be inspected; and
            1. that copies of the proposed material can be purchased and stating the places at which they can be purchased; and
              1. if applicable, that the proposed material is available on the Internet, free of charge, and stating the Internet site address; and
              2. allow a reasonable opportunity for persons to comment on the proposal to incorporate the proposed material by reference; and
                1. consider any comments made.

                  1. The Director-General—

                  2. may make copies of the proposed material available in any other way that he or she considers appropriate in the circumstances; and
                    1. must, if paragraph (a) applies, give notice in the Gazette stating that the proposed material is available in other ways and giving details of where or how it can be accessed or obtained.

                      1. The Director-General may comply with subclause (1)(c) (if applicable) by providing a hypertext link from an Internet site maintained by or on behalf of the Ministry of Health to a copy of the proposed material that is available, free of charge, on an Internet site that is maintained by or on behalf of someone else.

                      2. The references in this clause to material include, if the material is not in an official New Zealand language, as well as the material itself, an accurate translation of the material in an official New Zealand language.

                      3. A failure to comply with this clause does not invalidate regulations that incorporate material by reference in reliance on section 105F.

                      4. For the purposes of subclause (1)(c), the Director-General may not rely on section 66 of the Copyright Act 1994 as authority to make the proposed material available on an Internet site.

                      2Access to material incorporated by reference

                      1. This clause applies if regulations incorporating material by reference in reliance on section 105F are made.

                      2. The Director-General must—

                      3. make the material (the incorporated material) available for inspection during working hours, free of charge, at the head office of the Ministry of Health and any other places that the Director-General may, at his or her discretion, determine are appropriate; and
                        1. state where copies of the incorporated material are available for purchase; and
                          1. make copies of the incorporated material available, free of charge, on an Internet site maintained by or on behalf of the Ministry of Health, unless doing so would infringe copyright; and
                            1. give notice in the Gazette stating—
                              1. that the incorporated material is incorporated in the regulations and stating the date on which the regulations were made; and
                                1. that the incorporated material is available for inspection during working hours, free of charge, and stating the places at which it can be inspected; and
                                  1. that copies of the incorporated material can be purchased and stating the places at which they can be purchased; and
                                    1. if applicable, that the incorporated material is available on the Internet, free of charge, and stating the Internet site address.

                                    2. The Director-General—

                                    3. may make copies of the incorporated material available in any other way that he or she considers appropriate in the circumstances; and
                                      1. must, if paragraph (a) applies, give notice in the Gazette stating that the incorporated material is available in other ways and giving details of where or how it can be accessed or obtained.

                                        1. The Director-General may comply with subclause (2)(c) (if applicable) by providing a hypertext link from an Internet site maintained by or on behalf of the Ministry of Health to a copy of the incorporated material that is available, free of charge, on an Internet site that is maintained by or on behalf of someone else.

                                        2. The references in this clause to material are to—

                                        3. material incorporated by reference in the regulations; and
                                          1. if the material is not in an official New Zealand language, the material itself together with an accurate translation of the material in an official New Zealand language.

                                            1. A failure to comply with this clause does not invalidate regulations that incorporate material by reference.

                                            2. For the purposes of subclause (2)(c), the Director-General may not rely on section 66 of the Copyright Act 1994 as authority to make the incorporated material available on an Internet site.

                                            3Effect of material incorporated by reference

                                            1. This clause applies to material incorporated by reference in regulations in reliance on section 105F.

                                            2. Material to which this clause applies has legal effect as part of the regulations in which it is incorporated.

                                            4Effect of amendments to material incorporated by reference

                                            1. This clause applies if the material incorporated by reference in reliance on section 105F is amended by the originator of the material after the regulations are made.

                                            2. If this clause applies, any amendments made by the originator of the material have no legal effect as part of the regulations unless they are specifically incorporated by later regulations made under this Act.

                                            3. For the purposes of this section, material is amended if the material or any part of it—

                                            4. is amended or replaced; or
                                              1. expires or is revoked; or
                                                1. otherwise ceases to have effect.

                                                  5Proof of material incorporated by reference

                                                  1. A copy of material incorporated by reference in regulations in reliance on section 105F must be—

                                                  2. certified as a correct copy of the material by the Director-General; and
                                                    1. retained by the Director-General.

                                                      1. The production in proceedings of a certified copy of the material is, in the absence of evidence to the contrary, sufficient evidence of the material incorporated by reference in the regulations.

                                                      6Application of Legislation Act 2019 to material incorporated by reference

                                                      1. Subpart 1 of Part 3 and section 114 of the Legislation Act 2019 do not apply to material that is incorporated by reference in regulations in reliance on section 105F of this Act merely because it is incorporated.

                                                      Notes
                                                      • Schedule 3 clause 6: replaced, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).

                                                      7Application of Regulations (Disallowance) Act 1989 to material incorporated by reference (Repealed)

                                                        Notes
                                                        • Schedule 3 clause 7: repealed, on , by section 39 of the Medicines Amendment Act 2013 (2013 No 141).

                                                        8Application of Standards and Accreditation Act 2015, other enactments, and rules of law not affected

                                                        1. Nothing in this schedule affects the application of sections 29 to 32 of the Standards and Accreditation Act 2015, any other enactment, or any rule of law.

                                                        Notes
                                                        • Schedule 3 clause 8 heading: amended, on , by section 45(1) of the Standards and Accreditation Act 2015 (2015 No 91).
                                                        • Schedule 3 clause 8: amended, on , by section 45(1) of the Standards and Accreditation Act 2015 (2015 No 91).