Therapeutic Products Bill - Amendment paper No 375
Therapeutic Products Bill - Amendment paper No 375
No 375
House of Representatives
Supplementary Order Paper
Tuesday, 18 July 2023
Therapeutic Products Bill
Proposed amendments
Dr Shane Reti, in Committee, to move the following amendments:
Clause 14
In clause 14, delete the definition of export authorisation (page 25, lines 4 and 5).
Clause 59
In clause 59(3)(c), replace “:”
(page 54, line 19) with “.”
.
In clause 59(3), delete paragraph (d) (page 54, lines 20 to 22).
Clause 67
In clause 67(2), before paragraph (a) (page 61, before line 7), insert:
(aaa)
the medicine or medical device meets all applicable export standards; or
In clause 67(2)(a), replace “, provisional authorisation, or export authorisation”
(page 61, lines 7 and 8) with “or provisional authorisation”
.
In clause 67(4)(a), delete “or an export authorisation”
(page 61, line 18).
Clause 117
In clause 117(1), replace “3 kinds”
(page 87, line 6) with “2 kinds”
.
In clause 117(1)(b), replace “:”
(page 87, line 14) with “.”
.
In clause 117(1), delete paragraph (c) (page 87, lines 15 to 18).
Clause 120
In clause 120, delete subclause (3) (page 90, lines 28 to 31).
Clause 121
In clause 121(1), delete paragraph (c) (page 91, lines 16 to 19).
Clause 122
In clause 122(1), delete “or an export authorisation”
(page 91, lines 34 and 35).
Clause 124
In clause 124(1), delete paragraph (f) (page 93, lines 9 and 10).
Clause 125
In clause 125(1), delete paragraph (c) (page 93, lines 30 to 33).
Clause 131
In clause 131(2)(c), delete “or an export authorisation”
(page 96, line 33).
Clause 141
In clause 141, delete subclause (1) (page 100, lines 29 and 30).
Clause 192
In clause 192(2), delete “or (c)”
(page 124, line 27).
Clause 253
In clause 253(1)(b)(i), delete “or an export authorisation”
(page 153, line 20).
Explanatory note
This Supplementary Order Paper (SOP) amends the Therapeutic Products Bill. Under the Bill, medicines that are manufactured in New Zealand for the export market, with no intention of supply in New Zealand, will require export authorisation. This is despite the fact that regulatory requirements in the country of export will require compliance. The requirement for export authorisation will result in increased costs and delays which at one level will be unmanageable and at another will render New Zealand exporters less competitive.
This SOP removes the requirement for medicines and medical devices to have export authorisation. It would allow a medicine or medical device to be exported provided it meets all applicable export standards.