In forceAmendedAs enacted

Contents

Health Products (Therapeutic Products) Regulations 2016 · As enacted · Part 3 · Supply of Therapeutic Products

17. Supply by dispensing therapeutic products

Amended

Last amended by an amending law of 2023. 2 amendments in all.

(1)

A relevant person may dispense a therapeutic product only if the package or container of the therapeutic product is labelled with all of the following information in English:

(a)

the name of the person to whom the therapeutic product is to be administered;

(b)

where the product is supplied or dispensed —

(i)

at a licensed retail pharmacy — the name, address and any identification number or logo of the licensed retail pharmacy;

(ii)

at any approved permanent premises by a healthcare service licensee under a business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee;

(iii)

at any temporary premises or approved conveyance by a healthcare service licensee under a business name —

(A)

if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or

(B)

in any other case — the business name, address and any identification number or logo of the healthcare service licensee; or

(iv)

by a healthcare service licensee using a remote service kiosk or by delivery under a business name —

(A)

(B)

in any other case — the business name, address and any identification number or logo of the healthcare service licensee;

(c)

the date that the therapeutic product is dispensed;

(d)

the directions for use of the therapeutic product;

(e)

the name of the therapeutic product, being either the proprietary name or the appropriate non-proprietary name;

(f)

where the appropriate non-proprietary name is included on the label, the appropriate quantitative particulars of any active ingredient of the therapeutic product.

(2)

A prescription-only medicine may be dispensed only in accordance with the following requirements:

(a)

where the qualified practitioner or collaborative prescribing practitioner giving the prescription does not specify that the prescription is to be repeated, the relevant person dispensing the prescription-only medicine must —

(i)

when dispensing, mark the prescription in a manner so as to permanently attach the person’s name and address and the dispensing date to the prescription; and

(ii)

retain the prescription for a period of at least 2 years after dispensing; or

(b)

where the qualified practitioner or collaborative prescribing practitioner giving the prescription specifies that the prescription is to be repeated, the relevant person dispensing the prescription-only medicine —

(i)

must not dispense more than the total number of times specified on the prescription;

(ii)

when dispensing, must mark the prescription in such a manner as to permanently attach the person’s name and address and the dispensing date to the prescription; and

(iii)

must retain the prescription for a period of at least 2 years after dispensing for the last time.

(3)

In this regulation, “relevant person” means —

(a)

a qualified practitioner or collaborative prescribing practitioner, or a person acting under the supervision of a qualified practitioner or collaborative prescribing practitioner; or

(b)

a qualified pharmacist or a person acting under the supervision of a qualified pharmacist.

Subregulation 1

A relevant person may dispense a therapeutic product only if the package or container of the therapeutic product is labelled with all of the following information in English:

(a)

the name of the person to whom the therapeutic product is to be administered;

(b)

where the product is supplied or dispensed —

(i)

at a licensed retail pharmacy — the name, address and any identification number or logo of the licensed retail pharmacy;

(ii)

(iii)

at any temporary premises or approved conveyance by a healthcare service licensee under a business name —

(A)

(B)

in any other case — the business name, address and any identification number or logo of the healthcare service licensee; or

(iv)

by a healthcare service licensee using a remote service kiosk or by delivery under a business name —

(A)

(B)

in any other case — the business name, address and any identification number or logo of the healthcare service licensee;

(c)

the date that the therapeutic product is dispensed;

(d)

the directions for use of the therapeutic product;

(e)

the name of the therapeutic product, being either the proprietary name or the appropriate non-proprietary name;

(f)

where the appropriate non-proprietary name is included on the label, the appropriate quantitative particulars of any active ingredient of the therapeutic product.

Subregulation 2

A prescription-only medicine may be dispensed only in accordance with the following requirements:

(a)

(i)

when dispensing, mark the prescription in a manner so as to permanently attach the person’s name and address and the dispensing date to the prescription; and

(ii)

retain the prescription for a period of at least 2 years after dispensing; or

(b)

(i)

must not dispense more than the total number of times specified on the prescription;

(ii)

when dispensing, must mark the prescription in such a manner as to permanently attach the person’s name and address and the dispensing date to the prescription; and

(iii)

must retain the prescription for a period of at least 2 years after dispensing for the last time.

Subregulation 3

In this regulation, “relevant person” means —

(a)

a qualified practitioner or collaborative prescribing practitioner, or a person acting under the supervision of a qualified practitioner or collaborative prescribing practitioner; or

(b)

a qualified pharmacist or a person acting under the supervision of a qualified pharmacist.

Report

Read on from reg 18

Part 4