New Zealand Acts

MEDICINES AMENDMENT ACT 2013 - SECT 35

35 Regulations

1 Section 105(1)(a) is amended by omitting, and the manner of making applications under this Act.

2 Section 105(1) is amended by inserting the following paragraph after paragraph (a):

aaa) prescribing, in relation to any application or class of application under this Act, any of the following:

i) the manner in which the application must be made; and

ii) the information that must accompany or be contained in the application; and

iii) the manner in which the application must be determined by the decision-maker; and

iv) any matters that the decision-maker must take into account when determining the application:

3 Section 105(1) is amended by repealing paragraph (i) and substituting the following paragraph:

i) specifying, by name or description, substances or articles, or kinds or classes of substances or articles, that are, or are not, medicines or medical devices for the purposes of this Act:

4 Section 105(1)(q) is amended by omitting practitioners, veterinarians, registered midwives, and designated prescribers of prescriptions for the supply of any medicine and substituting authorised prescribers, veterinarians, and delegated prescribers of prescriptions for the supply of any medicine, including the transmission and storage of prescriptions.

5 Section 105(1) is amended by repealing paragraph (qa) and substituting the following paragraphs:

qa) authorising any class of registered health professional to prescribe specified prescription medicines, or a specified class or description of prescription medicines, in accordance with any conditions, limitations, requirements, or restrictions specified in or imposed under the regulations:

qaa) granting and regulating delegated prescribing rights:

6 Section 105 is amended by inserting the following subsections after subsection (5):

5A For the purposes of subsection (1)(qa),—

a)
"specified prescription medicines" means prescription medicines specified by the Director-General by notice in the Gazette; and

b)
"specified class or description of prescription medicines" means a class or description of prescription medicines specified by the Director-General by notice in the Gazette.

5B Before issuing a notice under subsection (5A), the Director-General must consult with those organisations or bodies that appear to the Director-General to be representative of persons likely to be substantially affected by the notice.