Medicines Regulations 1984

  • not the latest version
  • This version was replaced on 7 November 2018 to make corrections to Schedule 1 Part 1 item 787 under section 25(1)(j)(ii) of the Legislation Act 2012.
2 Interpretation

(1)

In these regulations, unless the context otherwise requires,—

Act means the Medicines Act 1981

appropriate designation, in relation to a medicine, or an ingredient of a medicine, or a related product, or an active ingredient of a related product, has the following meaning in each of the cases specified:

(a)

where the medicine, related product, or ingredient is named or described in a monograph contained in the current edition of a specified publication, the term means the name or one of the synonyms used in that specified publication for that medicine, related product, or ingredient:

(b)

where the medicine, related product, or ingredient—

(i)

is not named or described in a monograph contained in the current edition of any specified publication but was named or described in a monograph contained in an earlier edition; and

(ii)

is not sold under any name or description except the name or one of the synonyms used in that earlier edition for that medicine, related product, or ingredient,—

the term means the name or one of the synonyms so used in that earlier edition followed immediately by a reference to that earlier edition:

(c)

where neither paragraph (a) nor paragraph (b) applies, the term means—

(i)

the international non-proprietary name of the medicine, related product, or ingredient; or

(ii)

if it has no international non-proprietary name, the name appearing in a list published in the United Kingdom on the recommendation of the Medicines Commission pursuant to section 100 of the Medicines Act 1968 (UK); or

(iii)

if the medicine, related product, or ingredient has neither an international non-proprietary name nor a name appearing in a list referred to in subparagraph (ii), its accepted scientific name or some other name descriptive of the true nature of the medicine, related product, or ingredient

appropriate quantitative particulars, in relation to any active ingredients of a medicine or of a related product,—

(a)

where the medicine or related product consists of or comprises tablets, capsules, or other separate portions, means the quantity (expressed by weight or volume) of each of the ingredients contained in each portion; or

(b)

in any other case, means the percentage of each of those ingredients contained in the medicine or related product, or the quantity of each of those ingredients contained in a stated quantity of the medicine or related product

approved immunisation programme means a vaccination programme—

(a)

pursuant to the National Immunisation Schedule administered by Pharmac; or

(b)

approved by the Director-General or a Medical Officer of Health

biochemical preparation includes—

(a)

an antigen; and

(b)

an antitoxin; and

(c)

a toxin; and

(d)

a blood fractionation preparation; and

(e)

an insulin; and

(f)

a preparation from a mammalian gland; and

(g)

a serum; and

(h)

a vaccine; and

(i)

any other substance or preparation that is similar in nature to any of those specified in paragraphs (a) to (h),—

whether natural or synthetic, that is intended for diagnostic, prophylactic, or therapeutic purposes

consent to distribute, in relation to any medicine or related product, means a consent to the distribution of that medicine or related product given by the Minister under section 20 of the Act; and includes a provisional consent given under section 23 of the Act

controlled drug has the same meaning as in the Misuse of Drugs Act 1975

described, in relation to any medicine, related product, or medical device, means represented or held out (whether in writing or otherwise) by the manufacturer, seller, or supplier of the medicine, related product, or medical device

dispensary technician means a person who holds a certificate issued by the Pharmaceutical Society of New Zealand before 18 September 2004 that—

(a)

classifies the holder as a dispensary assistant; or

(b)

records that the person has completed the requirements of the Pharmacy Technicians Certificate

for external use, in relation to any medicine or related product, means for application to the anal canal, ear, eye, mucosa of the mouth, nose, skin, teeth, throat, or vagina, where local action only is required and where extensive systemic absorption will not occur; but nothing in these regulations relating to medicines or related products intended for external use shall apply to nasal drops, nasal inhalations, nasal sprays, teething applications, throat lozenges, throat pastilles, throat sprays, or throat tablets

general sale medicine has the meaning given to it by section 99(2) of the Act

Pharmac means the Pharmaceutical Management Agency established by section 46 of the New Zealand Public Health and Disability Act 2000

Pharmacy Council means the Pharmacy Council established by section 114(5) of the Health Practitioners Competence Assurance Act 2003

pharmacy graduate means a person who is not a pharmacist, but who—

(a)

has 1 or more of the qualifications prescribed by the Pharmacy Council under section 12(1) of the Health Practitioners Competence Assurance Act 2003 for registration as a pharmacist; and

(b)

is actively taking steps towards registration as a pharmacist

pharmacy student means a person who is undertaking, but has not yet completed, the course and examinations leading to a qualification of a kind prescribed by the Pharmacy Council under section 12(1) of the Health Practitioners Competence Assurance Act 2003

pharmacy technician means any person who has a National Certificate in Pharmacy (Technician)

pharmacy technician student means a person who is undertaking, but who has not yet completed, training and examinations leading to a National Certificate in Pharmacy (Technician)

poison bottle means a container that is made of glass, plastic, or other like material, and that either—

(a)

has embossed on at least one-third of its outer surface narrow flutings, ribs, nettings, or points, or other similar surface impressions readily recognisable by touch; or

(b)

has clearly embossed on 2 opposite sides of the shoulder of the container the word “POISON” in capital letters, the height of the letters being not less than half the width of that shoulder

principal display panel means the part of a label that is most likely to be displayed, presented, shown, or examined under ordinary or customary conditions of display; and, if such likelihood is equal in respect of 2 or more panels, means every such panel

printed includes written, typewritten, engraved, lithographed, or otherwise traced or copied

registered midwife means a health practitioner who is, or is deemed to be, registered with the Midwifery Council established by section 114(3) of the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of midwifery

safety container means a container, whether or not part of a strip of containers, that—

(a)

encloses a single tablet or other single item of a medicine that is a solid or a class of medicines that are solids (including a medicine or class of medicines in powder form); and

(b)

is made of aluminium foil or laminated plastic, or such other material as may be approved by the Director-General in relation to the packaging of any solid medicine to which regulation 37 applies, either by notice in the Gazette or in writing addressed to a particular manufacturer, packer, importer, or seller of medicines; and

(c)

is reasonably resistant to attempts by young children to open it

specified publication means a publication named in section 108(1) of the Act

student means a pharmacy student or a pharmacy technician student.

(2)

In these regulations, unless the context otherwise requires, all references to proportions in a medicine (whether as percentages, parts per million, or otherwise) shall be references to—

(a)

proportions by weight, where the medicine is a solid; or

(b)

proportions by volume, where the medicine is a liquid at ambient temperatures.

Regulation 2(1) approved immunisation programme: inserted, on 17 April 1992, by regulation 2 of the Medicines Regulations 1984, Amendment No 5 (SR 1992/43).

Regulation 2(1) approved immunisation programme paragraph (a): amended, on 29 November 2012, by regulation 4(1) of the Medicines Amendment Regulations 2012 (SR 2012/329).

Regulation 2(1) approved school: revoked, on 1 August 2011, by regulation 4(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) colouring substance: revoked, on 1 August 2011, by regulation 4(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) designated prescriber nurse: revoked, on 1 October 2005, by regulation 3 of the Medicines Amendment Regulations 2005 (SR 2005/255).

Regulation 2(1) Dispensary Assistant’s Certificate: revoked, on 1 August 2011, by regulation 4(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) dispensary technician: substituted, on 1 August 2011, by regulation 4(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) general sale medicine: inserted, on 1 August 2011, by regulation 4(3) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) Pharmac: inserted, on 29 November 2012, by regulation 4(2) of the Medicines Amendment Regulations 2012 (SR 2012/329).

Regulation 2(1) Pharmacy Council: inserted, on 1 August 2011, by regulation 4(4) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) pharmacy graduate: substituted, on 1 August 2011, by regulation 4(5) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) pharmacy student: substituted, on 1 August 2011, by regulation 4(5) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) pharmacy technician: substituted, on 1 August 2011, by regulation 4(5) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) pharmacy technician student: inserted, on 19 December 2002, by regulation 3(3) of the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).

Regulation 2(1) registered midwife: substituted, on 18 September 2004, by section 175(3) of the Health Practitioners Competence Assurance Act 2003 (2003 No 48).

Regulation 2(1) safety container paragraph (b): amended, on 1 January 1995, by regulation 2 of the Medicines Regulations 1984, Amendment No 6 (SR 1994/299).

Regulation 2(1) student: added, on 19 December 2002, by regulation 3(4) of the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).