1Short titleThis regulation may be cited as the Health (Drugs and Poisons) (COVID-19 Vaccination Services) Amendment Regulation 2021.2Regulation amendedThis regulation amends the Health (Drugs and Poisons) Regulation 1996.3Amendment of s 143 (Offence to wholesale restricted drug without licence)Section 143—insert—Note—See, however, section 213G in relation to persons authorised under part 9A, division 3.4Amendment of s 146 (Endorsement needed for restricted drugs)Section 146—insert—Note—See, however, section 213G in relation to persons authorised under part 9A, division 3.5Amendment of s 200 (Authorised persons to obtain restricted drugs on purchase order) (1)Section 200—insert—(5A)This section does not apply to an authorised person who obtains a COVID-19 vaccine under the Australian COVID-19 vaccination arrangements.(2)Section 200(5A) and (6)—renumber as section 200(6) and (7).6Insertion of new ch 3, pt 9AChapter 3—insert—Part 9ASpecial provisions for COVID-19 vaccination servicesDivision 1Preliminary213B Purpose of partThe purpose of this part is to—

(a)allow the chief executive to—

(i)publish a code to facilitate the provision of COVID-19 vaccination services, subject to special requirements; and

(ii)declare particular persons to be declared providers for providing those services; and

(b)authorise declared providers, and workers for those providers, to undertake particular activities for providing those services; and

(c)allow the chief executive to give personal information reported to the chief executive under the code to other entities for particular purposes.

213C Relationship with other regulation provisionsNothing in this part—

(a)limits another provision of this regulation under which a person is authorised to carry out an activity in relation to a COVID-19 vaccine or related drug; or

(b)prevents a person carrying out an activity in relation to a COVID-19 vaccine or related drug that is lawful without an endorsement.

213D Definitions for partIn this part—COVID-19 vaccination centre means a place at which a COVID-19 vaccination service is provided.COVID-19 vaccination code see section 213E(1).COVID-19 vaccination service means a health service established, under the Australian COVID-19 vaccination arrangements, primarily for administering COVID-19 vaccines to members of the public.declared provider, of a COVID-19 vaccination service, means a person declared to be a declared provider for the service under section 213F.health service see the Health Ombudsman Act 2013, section 7.personal information see the Information Privacy Act 2009, section 12.related drug, in relation to a COVID-19 vaccine, means an S3 poison or restricted drug used for the therapeutic treatment of a person having an adverse reaction to the vaccine.Examples—

•an adrenaline ampoule

•a pre-loaded device for the management of anaphylaxis such as an EpiPen

worker, for a declared provider of a COVID-19 vaccination service—

(a)means a person employed or engaged by the provider of the service; and

(b)includes a person engaged as a student or volunteer by the provider of the service.

Division 2Code for, and declared providers of, vaccination services213E COVID-19 vaccination code(1)The chief executive may publish a document (the COVID-19 vaccination code) on the department’s website stating the requirements for providing COVID-19 vaccination services under this part.(2)The COVID-19 vaccination code must include requirements in relation to—

(a)the qualifications, training or supervision necessary for workers for declared providers of COVID-19 vaccination services; and

(b)the recording of information related to the provision of the services; and

(c)the reporting of information, including personal information, related to the provision of the services.

(3)Without limiting subsection (1) or (2), the COVID-19 vaccination code may also include requirements in relation to any of the following matters for COVID-19 vaccination services—

(a)specifications for providing the services or setting up COVID-19 vaccination centres;

(b)procedures for prioritising who to vaccinate;

(c)procedures for assessing the health and suitability of persons to be vaccinated;

(d)procedures for safely preparing COVID-19 vaccines or related drugs;

(e)procedures for obtaining, selling, supplying, issuing or disposing of COVID-19 vaccines or related drugs;

(f)procedures for safely or securely storing COVID-19 vaccines or related drugs.

(4)The COVID-19 vaccination code has effect from—

(a)the day it is published on the department’s website; or

(b)if a later day of effect is stated in the code—on the later day.

213F Declaring providers of vaccination services(1)The chief executive may, by notice published on the department’s website, declare a person to be a declared provider for providing a COVID-19 vaccination service under this part.(2)A declaration may be made under subsection (1) only if the chief executive is satisfied—

(a)the person, and workers for the person, will be able to comply with the COVID-19 vaccination code when providing the COVID-19 vaccination service; and

(b)an appropriately qualified individual will be responsible for overseeing the provision of the COVID-19 vaccination service.

(3)A notice published under subsection (1) must state—

(a)the name of the person declared; and

(b)the name and contact details of the individual who is responsible for overseeing the provision of the COVID-19 vaccination service.

Division 3Authorised activities for vaccination services213G Effect of authorisation for regulation offencesA person authorised under this division to carry out an activity does not commit an offence against another provision of this regulation to the extent—

(a)the person acts under this division; and

(b)if the person carrying out the activity is a worker for a declared provider of a COVID-19 vaccination service—

(i)the worker is permitted by the provider to carry out the activity for the provider; and

(ii)the granting of the permission does not contravene the COVID-19 vaccination code.

213H Obtaining, selling and supplying vaccines and related drugs(1)A declared provider of a COVID-19 vaccination service, or a worker for the provider, may, under the COVID-19 vaccination code, obtain COVID-19 vaccines or related drugs for the service.(2)An authorised supplier of COVID-19 vaccines or related drugs may, under the COVID-19 vaccination code, sell or supply the vaccines or drugs to a declared provider of a COVID-19 vaccination service, or a worker for the provider.(3)A declared provider of a COVID-19 vaccination service, or a worker for the provider, may, under the COVID-19 vaccination code, sell or supply COVID-19 vaccines or related drugs to another declared provider, or a worker for the other provider.(4)In this section—authorised supplier, of a COVID-19 vaccine or related drug, means a person from whom a declared provider may, under the COVID-19 vaccination code, obtain the vaccine or drug.213I Possessing vaccines and related drugs for transportation(1)A person engaged to transport a COVID-19 vaccine or related drug to or from a relevant place may, under the COVID-19 vaccination code, possess the vaccine or drug.(2)In this section—relevant place means a COVID-19 vaccination centre or another place at which it is necessary to keep a COVID-19 vaccine or related drug for providing a COVID-19 vaccination service.213J Issuing vaccines and related drugs(1)A declared provider of a COVID-19 vaccination service may, under the COVID-19 vaccination code, issue a COVID-19 vaccine or related drug to a worker for the provider.(2)A worker for a declared provider of a COVID-19 vaccination service may, under the COVID-19 vaccination code, issue a COVID-19 vaccine or related drug to another worker for the provider.213K Possessing and administering at vaccination centresA worker for a declared provider of a COVID-19 vaccination service may, under the COVID-19 vaccination code, possess or administer a COVID-19 vaccine or related drug at a COVID-19 vaccination centre.213L Disposing of vaccines and related drugsA declared provider of a COVID-19 vaccination service, or a worker for the provider, may, under the COVID-19 vaccination code, dispose of a COVID-19 vaccine or related drug.Division 4Information sharing213M Giving personal information for particular purposes(1)This section applies in relation to personal information reported to the chief executive under the COVID-19 vaccination code.(2)The chief executive may give the personal information to an entity to—

(a)facilitate the safe and effective therapeutic treatment of persons vaccinated at COVID-19 vaccination centres; orExample—giving personal information to a third party to provide a messaging service to notify vaccinated persons about health matters

(b)report to the entity, or facilitate reporting to the entity, in relation to the use of COVID-19 vaccines under the Australian COVID-19 vaccination arrangements.

(3)However, when giving the personal information, the chief executive must ensure the privacy of any persons to whom the information relates is protected from unjustified intrusion, to the extent possible.7Amendment of appendix 9 (Dictionary)(1)Appendix 9, definition approval—omit.(2)Appendix 9—insert—approval—

(a)means an approval given by the chief executive under this regulation for a person to do a thing; but

(b)does not include a declaration made under section 213F.

Australian COVID-19 vaccination arrangements means the arrangements made under the Australian COVID-19 vaccination policy to provide COVID-19 vaccines for vaccinating members of the public.Australian COVID-19 vaccination policy means the document called ‘Australian COVID-19 Vaccination Policy’, published by the Australian Government.Note—The Australian COVID-19 vaccination policy was first endorsed by the National Cabinet on 13 November 2020.COVID-19 vaccination centre, for chapter 3, part 9A, see section 213D.COVID-19 vaccination code, for chapter 3, part 9A, see section 213E(1).COVID-19 vaccination service, for chapter 3, part 9A, see section 213D.COVID-19 vaccine means a vaccine for COVID-19.declared provider, of a COVID-19 vaccination service, for chapter 3, part 9A, see section 213D.health service, for chapter 3, part 9A, see section 213D.personal information, for chapter 3, part 9A, see section 213D.related drug, in relation to a COVID-19 vaccine, for chapter 3, part 9A, see section 213D.worker, for a declared provider of a COVID-19 vaccination service, for chapter 3, part 9A, see section 213D.