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MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATION 2008 (NO 42 OF 2008) - NOTES

- made under the Medicines, Poisons and Therapeutic Goods Act 2008

Dictionary

(see s 3)

Note 1     The Legislation Act contains definitions and other provisions relevant to this regulation.

Note 2     For example, the Legislation Act, dict, pt 1, defines the following terms:

              •     child

              •     correctional centre

              •     doctor

              •     nurse

              •     nurse practitioner

              •     optometrist

              •     public employee.

Note 3     Terms used in this regulation have the same meaning that they have in the Medicines, Poisons and Therapeutic Goods Act 2008 (see Legislation Act, s 148). For example, the following terms are defined in the Medicines, Poisons and Therapeutic Goods Act 2008, dictionary:

              •     controlled medicine (see s 11)

              •     dangerous poison (see s 12)

              •     deals, with a regulated substance (see s 19)

              •     deals, with a regulated therapeutic good (see s 21)

              •     hospital

              •     institution

              •     medicines and poisons standard (see s 15)

              •     prescription only medicine (see s 11)

              •     prohibited substance (see s 13)

              •     purchase order

              •     regulated substance (see s 10)

              •     residential aged care facility

              •     signs

              •     supply (see s 24)

              •     supply authority (see s 23)

              •     ward

              •     written.

"appendix D medicines approval"—see section 590.

"approved analyst" means—

        (a)     an analyst appointed under the Public Health Act 1997, section 15 who is authorised under that Act to exercise a function under the Act; or

        (b)     an analyst appointed or authorised under another territory law or a law of the Commonwealth, a State or another Territory.

Australian code of good wholesaling practice for therapeutic goods for human use means the Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use prepared by the National Coordinating Committee on Therapeutic Goods, as in force from time to time.

Note     The code is accessible at www.tga.gov.au.

"bioequivalent"—a form of a substance is the bioequivalent of another form of the substance if the forms are physiologically equivalent in their clinical effect.

"CHO" means chief health officer.

"community pharmacy" means a pharmacy at a place other than an institution.

"complying purchase order" means—

        (a)     for a medicine—a purchase order that complies with section 62; or

        (b)     for a dangerous poison—a purchase order that complies with section 721; or

        (c)     for an appendix C substance or prohibited substance—see section 772.

condition 1, for a doctor prescribing or supplying a designated appendix D medicine to a woman of child-bearing age, for schedule 3 (Designated appendix D medicines—standing approvals)—see schedule 3, section 3.1.

condition 2, for a doctor prescribing or supplying a designated appendix D medicine to a woman of child-bearing age, for schedule 3—see schedule 3, section 3.1.

condition 3, for a doctor prescribing or supplying a designated appendix D medicine to a woman of child-bearing age, for schedule 3—see schedule 3, section 3.1.

condition 4, for a doctor prescribing or supplying a designated appendix D medicine to a woman of child-bearing age, for schedule 3—see schedule 3, section 3.1.

"controlled medicines approval"—see section 550.

"controlled medicines register" means a register for controlled medicines.

controlled medicines research and education program licence—see section 600.

"custodian", of an animal, means—

        (a)     an adult who has lawful custody of the animal; or

        (b)     if the animal is owned by a child or a person with a guardian—a parent or guardian of the child or person.

"CYP authorised person"—see the Children and Young People Act 2008, dictionary, definition of authorised person.

"CYP detention place" means a detention place under the Children and Young People Act 2008.

"dangerous poisons manufacturers licence"—see section 700.

"dangerous poisons register" means a register for dangerous poisons.

dangerous poisons research and education program licence—see section 700.

"dangerous poisons suppliers licence"—see section 700.

"day hospital "means a facility where a person is admitted for surgical or medical treatment and discharged on the same day.

"dentist" does not include a trainee dentist.

Note     See the definition of trainee.

"designated appendix D medicine" means a medicine listed in schedule 3, (Designated appendix D medicines—standing approvals), part 3.2, column 3.

Note     The medicines are included in the medicines and poisons standard, appendix D.

"designated prescriber", for part 13.1 (Controlled medicines approvals)—see section 551.

"designated prescription only medicine", for part 4.3 (Authorisation to supply without prescription in emergencies)—see section 250.

"detainee"—see the Corrections Management Act 2007, section 6.

"disability care" means care that is provided to a person with a disability in a residential facility in which the person is also provided with accommodation that includes—

        (a)     appropriate staff to meet the nursing and personal care needs of the person; and

        (b)     meals and cleaning services; and

        (c)     furnishings, furniture and equipment for the provision of the care and accommodation.

"doctor" does not include an intern doctor.

Note     See the definition of intern.

"endorsement", for division 13.1.4 (Endorsements to treat drug-dependency)—see section 580.

"enrolled nurse" includes an enrolled nurse (medications).

"enrolled nurse (medications)" means an enrolled nurse who is registered under the Health Professionals Act 2004 in the specialist area of enrolled nurse (medications).

"environmental authorisation" means—

        (a)     an environmental authorisation under the Environment Protection Act 1997; or

        (b)     an authorisation (however described) under a Commonwealth or State law that corresponds to the environmental authorisation mentioned in paragraph (a).

"first-aid kit" includes a portable bag or container of medicines and other medical supplies kept by a person for health care or emergency treatment.

"first-aid kit licence"—see section 600.

"health profession"—see the Health Professionals Act 2004, dictionary.

"health professional" means a person who is registered under the Health Professionals Act 2004.

"in-patient", at an institution, includes—

        (a)     a patient being treated at an emergency department of the institution; and

        (b)     for a correctional centre—a detainee; and

        (c)     for a CYP detention place—a young detainee.

Note     A correctional centre and a CYP detention place is an institution (see s 652).

"intern", in relation to a doctor or pharmacist, means—

        (a)     for a doctor—a person who is conditionally registered as a medical practitioner under the Health Professionals Act 2004 because the person would be entitled to apply for unconditional registration if the person had completed a period of supervised training that the person has started; and

        (b)     for a pharmacist—a person who is undertaking a period of supervised practice or course of training, or both, to allow the person to be registered to practice without supervision.

"key", for chapter 11 (Storage of medicines)—see section 511.

"manufacturer's pack" means a primary pack for a medicine that is supplied by a manufacturer.

Note     See the definition of primary pack.

"medical records" includes—

        (a)     for a person at an institution—the person's clinical records and a medication chart for the person at the institution; and

        (b)     for a person who is not at an institution and is being treated by a prescriber—any record the prescriber keeps about the person.

"medicines Australia code of conduct" means the Medicines Australia Code of Conduct, authorised by the Australian Competition and Consumer Commission, as in force from time to time.

Note     The code is accessible at www.medicinesaustralia.com.au.

"medicines wholesalers licence"—see section 600.

"opioid dependency treatment guidelines" means the guidelines approved under section 630 (Guidelines for treatment of opioid dependency).

"opioid dependency treatment licence"—see section 600.

"optical device", for chapter 22 (Therapeutic goods)—see section 800.

"personal custody", of a key by a person, for part 11.4 (Additional storage requirements for controlled medicines)—see section 530.

"pharmacist" does not include an intern pharmacist.

Note     See the definition of intern.

"pharmacy medicines rural communities licence"—see section 600.

"prescribed person", for chapter 11 (Storage of medicines)—see section 510.

"prescriber", in relation to a medicine, means a person in relation to whom prescribing the medicine is included in schedule 1, column 3 in relation to the person.

"prescription", in relation to an optical device, for chapter 22 (Therapeutic Goods)—see section 800.

Note     Prescription, in relation to a medicine—see the Act, dictionary.

"primary pack" means the pack in which a regulated substance and its immediate container or immediate wrapper or measure pack are presented for sale or supply.

Note     This is the same as the definition in the medicines and poisons standard, par 1 (l), and is included because of its relationship to the meaning of manufacturer's pack. Other terms defined in the standard have the same meaning in this regulation, see the Act, s 16 (1).

"prohibited substance", for chapter 21 (Prohibited and appendix C substances)—see section 760.

"prohibited substances register" means a register for prohibited substances.

prohibited substances research and education program licence—see section 761.

"pseudoephedrine record"—see section 171 (c).

"recognised research institution"—see the Act, section 20 (5).

"relevant expiry date", for a medicine, means—

        (a)     if the medicine is from 1 batch—the expiry date for the batch; or

        (b)     if the medicine is from more than 1 batch—the expiry date that is closest to the date of dispensing.

"relevant law"—

        (a)     for chapter 16 (Low and moderate harm poisons)—see section 660; and

        (b)     for part 19.3 (Packaging and labelling of dangerous poisons)—see section 730.

"requisition" includes issue a requisition.

"reviewable decision", for chapter 23 (Notification and review of decisions)—see section 850.

"retail sale", for division 4.2.7 (Selling pseudoephedrine by retail)—see section 170.

schedule 1—a reference to schedule 1 includes a reference to a provision of the schedule.

"scientifically qualified person" means—

        (a)     a dentist, doctor, pharmacist, or veterinary surgeon; or

        (b)     a person who has been awarded a doctorate for scientific studies by the person.

Note     Dentist, doctor, pharmacist and "veterinary surgeon" does not include an intern or trainee (see defs of these terms).

"scope of employment" includes scope of engagement as a contractor.

"specialist" means—

        (a)     a doctor admitted to a specialist area of a health profession; or

        (b)     a doctor who is undergoing a course of training under the supervision of a person mentioned in paragraph (a), the successful completion of which will qualify the person to be admitted to a specialist area.

"specialist area", for a health profession—see the Health Professionals Regulation 2004, dictionary.

"terminal illness"—a person has a terminal illness if a specialist diagnoses the person as having a terminal illness and estimates the person's life expectancy to be less than 1 year.

Note     Specialist includes a doctor training in a specialist area (see def "specialist").

"trainee", in relation to a health professional (other than a doctor or pharmacist) means a person who is conditionally registered as a health professional to allow the person to undertake a period of supervised practice or course of training or both to allow the person to become registered to practice without supervision.

Examples—references to trainee

trainee dentist, trainee nurse and trainee veterinary surgeon

Note 1     For doctors and pharmacists, see the definition of intern.

Note 2     An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

"veterinary surgeon" does not include a trainee veterinary surgeon.

Note     See the definition of trainee.

"young detainee"—see the Children and Young People Act 2008, section 95.

Endnotes

1     Notification

    Notified under the Legislation Act on 15 September 2008.

2     Republications of amended laws

    For the latest republication of amended laws, see www.legislation.act.gov.au.






















© Australian Capital Territory 2008

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Australian Capital Territory

The Australian Capital Territory Executive makes the following regulation under the Medicines, Poisons and Therapeutic Goods Act 2008.

Dated 11 September 2008.

KATY GALLAGHER
Minister

SIMON CORBELL
Minister

2008-4200.jpg
Australian Capital Territory

Medicines, Poisons and Therapeutic Goods Regulation 2008

Subordinate Law SL2008-42



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