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Regulating Medicines Flashcards

1
Q

What legislation defines what a “medicine” is?

A

Medicines Act 3
(1) one or more human beings for a therapeutic purpose
Used in hospital or pharmacy or with standing order or retail sales which includes herbal
This act also considers pregnancy test as a medicine (b)(iii)
(b)(i) pharmacy or hospital
(b)(ii)practitioner or register midwife or designated
(b)(iii)retail sales including herbal

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2
Q

What does MA 3 NOT INCLUDE?

A 
2
A- dental surgery for filling cavities
B- bandaged or dressings except for medicated (curative function)
C- radioactive material
D- animal food with medicine 
E-animal remedy
F-other declared in act
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3
Q

What does MA 4 say?

A

Defines the meaning of therapeutic purpose
A- treating or preventing disease
B- diagnosing existence degree or extent of physiological conditions
C- effecting contraception
D- inducing anaesthesia
E- altering shape size structure or weight or human
F- preventing or interfering with physiological function or temporarily (terminating or postponing or increasing or accelerate)
E- cleaning soaking or lubricating contact lenses

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4
Q

What legislations state substances that are not medicines and what do they include?

A

MR 58

(1)
(A) dentifrice products that do not contain medicine in schedule 1 and not claimed to prevent decay or improve oral hygiene

(B) anti dandruff products that do not contain a medicine or claim therapeutic use except controlling dandruff or claimed to be effective in moisturising exfoliating or drying scalp and no other purposes

(C) anti acne product that doesn’t contain a medicine or no other therapeutic purpose claimed claimed to be effective in moisturising exfoliating or drying scalp and no other purposes

D- barrier cream that does not contain medicine and not claimed for other purposes except preventing nappy rash and no other purpose besides from providing a barrier to the transmission of moisture

E- antibacterial skin products provided that it does not contain a medicine specified in schedule 1 or not claimed for any other therapeutic purpose except for preventing spread of bacteria and is not presented for use in connection with risk of transmission of disease of disease from contact of blood or bodily fluids and not recommended for use in connection of provision of health services.

(2) E refers to piercing skin or mucous membrane and venipuncture or delivery of an injection

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5
Q

What is legislation defines a related product?

A 
MA94  
1- cosmetic / dentrice / food that claims it is effective for a therapeutic purpose but does not contain any medicine, any substance belonging to a class under this Act

2- new related product is not identical to any related product that could be sold lawfully for the same therapeutic purpose

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6
Q

What are the standard for medicines, related products, medical devices, cosmetics and surgical dressings?

A

MR4

  • conform to the description and tests set out in the publication
  • conform to tests for sterility set out in a specified publication
  • product for use on skin of baby, any inflamed, abraded or broken skin, shall be free of pathogenic organism
  • it should not contain any thing that is harmful, dangerous or offensive
  • surgical dressings should comply with regulation test
  • medical device should conform to a particular description
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7
Q

Define new medicine

A

MA3

(3) Not generally available in NZ before commencement of this act or during period of 5 years immediately after the date it becomes available:
- sale and distribution whihc Minister has not given his consent
- any that becomes a medicine for the first time under this act

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8
Q

Pharmacy Only

A

MA3
a- sold by retail only in pharmacy or hospital or any any shop described in section51(2) or with a license
b-supplied in circumstances corresponding to retail sale only pharmacy, hospital and shop with license and according to standing order

Restricted

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9
Q

Prescritpion Only

A

MA3

  • sold by retail only on prescription given by practitioner, midwife, vet or designated.
  • Supplied in circumstances corresponding to retail only under prescription by… and under standing order
  • Administered only with prescription given by, or under standing
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10
Q

Restricted Medicine

A

MA3

  • sold by retail by a pharmacist
  • supplied in circumstances corresponding to retail sale by pharmacist or according to standing order
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11
Q

How are medicines classified?

A

MA9
1- Minister shall appoint a classification committee who would make recommendation to minister in respect of the classification of medicines
3-shall consist of 2 people from medical association, 2 nominated by pharmacutical society and 2 officers of ministry of health

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12
Q

Which legislation describes the restriction on sale or supply of new medicines?

A

MA 20

(2) No person shall sell / distribute by way of gift or loan or sample / advertise the availability of medicine
(3) No consent given under this section shall deemed to warrant safety or efficacy
(4) any person that does not comply with 2 is liable on conviction of imprisonment not lasting more than 6 months or fine not exceeding $20,000

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13
Q

How are medicines are registered?

A

MA 21 - application for Minister’s consent
1- application should be made in the true name of manufacturer, importer, proprietor. It should be addressed to director general, accompanied by prescribed fee
2- requirements of application
-business address of person making application, true name and business address of each ingredient manufacturer
-name of medicine under which it will be distributed
- method of manufacture
-full statement of ingredients including quantity
-description of the quality of raw materials
-description of the form or forms of medicine
-recommended dose and frequency
-claims or representations to be made in respect of its usefulness and recommended use
-reports of tests on safety (for the purposes for which it is intended to be used)
-test reports made to control strength, quality, purity r safety and method of testing
-efficacy reports
-English
-evidence of distribution in any other country
-intended method of distribution
-name and address of place of manufacture

4- director general could require person to supply samples or further information or manufacture, intended sale, distribution or advertising

5- director general may require person to verify statutory declaration of any statement in application made via signing

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14
Q

Which legislation described the requirements of medicine changeMAs?

A

MA24
1- any time that there is a material change the director general must be notified in English writing describing the change and effect the change it might have on safety and efficacy

2- material change that includes:

  • purpose, recommended dosage, manner of administration
  • labelling, container or package
  • strength, quality, or purity
  • methods of manufacture or facilities for testing strength, quality, purity or safety
  • location of manufacturer

3- no person shall sell any medicine that has a material change where a notice is required to be given to DG or supply by gift loan or sample until after at least 90 days after the notice is given to DG

4- within 45 days of written notice DG may require further more information or samples set out in a written notice.

5- medicine should not be distributed in NZ or represented or recommended, advertised or labelled in terms set out in the notice without consent
If there is insufficient information about strength, quality, purity, safety or efficacy / method of manufacture or testing facilities DG should refer to minister and inform manufacturer in writing

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15
Q

Legislation that describes authorized prescriber supplying unapproved medicine.

A

MA25 - Refers to an authorized prescriber (practitioner, midwife and designated) can:
1- manufacturer pack and label a medicine that is specially prepared for a particular patient
2- sell or supply or procure a medicine for patient under their care.
3- administer or procure the administration to any patient
4-At the request another authorized prescriber to pack, label a medicine for a particular patient
5-At the request of another authorized prescriber can sell or supply to another authorized prescriber or person who has care of patient
6- may administer at the request of another authorised prescriber

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16
Q

Legislation that permits the supply of unapproved medicine to a medical practitioner.

A

MA29
1- supply to medical practitioner on request of any medicine required for treatment for a patient under their care or administer by any medical practitioner of any such medicine to any such patient

2- supply of a new medicine before consent of the Minister shall as soon as possible after end of every month in which he has sold or supplied any such medicine in writing, naming practitioner and patient, describing medicine and occasion and the place where medicine is sold and supplied

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17
Q

What is MA32A?

A

Exemption in respect of importation by the Crown.
1- Import medicine into NZ and sell the medicine or distribute it by the way of gift or loan or sample and it is not necessary for Crown to comply with any provisions of this Act

3- payment of fee on the application for a license to sell a medicine a medicine applies to the Crown

4, 5 and 6 - Nothing in section 24 prevent a person who holds a lisence or pharmacist in hospital or in community to sell a medicine imported by the Crow or supply if by gift or loan or sample

7-include the power to advertise, label and
package

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18
Q

What is MA33?

A

Exemption in respect of procuring and exporting medicines.
1- Any person may procure a medicine if the person whom procures the medicine is authorised under this Act to well or supply to him

2- Any person may export in the course or for the purpose of sale any medicine that at the time it is exported might lawfully be sold by a pharmacist to a person in NZ

19
Q

What is MA17?

A

Manufacturers, wholesalers to (packers of meds and operators of pharmacies be licensed)

1-No person shall in the course of any business 
a- manufacture
b- sell by wholesale
c-pack or label 
d- operate any pharmacy
otherwise in accordance with license
20
Q

Which legislation restrict manufacture of medicines in dwelling houses?

A

MR 30 -Dwelling houses prohibited for manufacture and packing

No person shall manufacture, pack any medicine, related product or cosmetic for sale in any dwellinghouse or permit any dwellinghouse to be used (if use likely to result in contamination)

21
Q

Exemption for pharmacists involved in manufacture of medicines

A

MA26
(1)(2) shall extend manufacture, packing, labelling, sellingor supplying of medicines to pharmacist employed in hospital or in a pharmacy

(3) (a)the sale or supply of any medicine must be given or requested by the person whom sold or supplied to or needs expressed by person
(b) prescription medicine according to prescription

(4) subsection 2 also applies to medicine compounded by a pharmacist to suit the needs of a particular person

22
Q

Exemption for vet and certain registered health practitioners for manufacture of medicine

A

MA27
a- vet may manufacture, sell, supply or administer to animal under their care or under care of another vet and may pack or label medicine for purpose of sale or supply

b- registered with optometrists and dispensing opticians board under HPCA Act and having appropriate scope of practice may sell or supply medicine for use in cleaning, soaking or lubricating contact lenses if med is suitable for purpose. This also includes packing or labelling of medicines for sale or supply

23
Q

Exemption for agents and employees regarding packing label and supply of medicines and any related products

A

MA31
1- To manufacture, sell,supply, pack or label any medicine other than restricted medicine or herbal remedy shall extend and apply to any agent or employee of a person so authorised acting in the course of that person’s agency or employment

2- Retail sale of prescription medicines extend and only apply to those under supervision of pharmacist, responsible person or other person licensed to sell them and this also applies to packing and labelling of medicines

3- Subsection 1 does not authorise person to manufacture sell supply pack of label any medicine at any place if that person principal employer is not authorised to

24
Q

What does MA39 say?

A

Adulteration of medicines

1 - No person shall
a- add any substance or abstract any substance from a medicine so as to affects the composition of the medicine with the intent that medicine shall be sold or supplied in that state
b- sell or supply any medicine the composition of which has been injuriously affected by the addition or abstraction of any substance

25
Which legislation describes the reporting of untoward effects of medicines
MA41 - Duty of importer or manufacture to report untoward effects of medicines 1- if at any time they have reason to believe that any substantial untoward effects have arisen from the use of the medicine in NZ or elsewhere shall notify DG of the nature of those effects and circumstances in which they have arisen so far as they are known to him 2- commits offence is liable to a fine not exceeding $1000
26
What is MA 42?
Duty of importer and manufacturer to have and produce specifications of medicines 1- No importer or manufacturer shall sell supply or distribute by way of gift or loan or sample or advertise any medicine other than herbal unless in possession of a- details of specifications for testing quality b- certificate of the results of testing in respect to every batch of medicine that is or to be distributed in NA 2- shall supply to an officer the details and certificates referred in subsection 1
27
Which legislation permits the supply of medicines for clinical trials?
MA30 1- must be approved by DG by recommendation of the health research council NZ for medicine to be distributed for sole purpose of obtaining clinical and scientific information with respect to safety and efficacy 2- application to DG must be in prescribed manner, addressed to DG, set out true name of applicant, be accompanied by prescribed fee and state information in subsection 3 3- 2(d) includes nature of medicines, name and chemical formula, purpose of trial, names and qualification and CV of investigators who will conduct trial, written consent to nomination from each investigator and information supplied to investigators 3f - protocol of trial including number of patients involved, form that trial is to take and nature of records kept, person or type of people specially excluded from trial, special measure taken place to ensure safety of participants names and addresses of institute and labs where they will be used will be supplied
28
Requirements for distribution of medicines used in clinical trials
MA30 7 - identifying name should be recognized - label every package or container with "To be used by qualified investigators only" - take all reasonable steps person is qualified to carry out, necessary facilities available for trials conducted d- importer or manufacturer to keep complete and accurate records of all quantities supplied and keep DG informed of progress every 6 month reports and copy of results of trial must be given to DG on its completion 8- DG may at any time revoke or suspend his approval of a clinical trial by writing
29
Which legislation describes the securities of pharmacies?
MA42B 1- at all times every prescription or restricted medicine should be secured in a way that prevents public gaining ready access to the medicine
30
Which legislation described the storage and delivery of medicines?
MA47 1- No person shall put medicine.. a- in cupboard, box, shelf or other place of storage in which food or drink are stored or kept for ready use or b-in any place to which young children or unauthorised person have ready access too 2-No person shall pack any medicine or prepare in for use in any room or on any table or bench used for purpose of packing preparing or consuming any food or drink 3- prescription or restricted medicine is kept at any time in any building or vehicle shall leave it unattended unless it has taken reasonable steps to secure building or vehicle against unlawful entry 4- must be handed to the person or person acting on that persons behalf to whom it is addressed or for whose use it is intended
31
What are the requirements for places of manufacture, storage and sale?
MR29 - Places of manufacture, storage and sale No person shall use any place or permit any place for sale of any medicine, related product or cosmetic for sale unless it complies with following: a- kept adequately lighted by daylight or artificial light at all times work is carried out b- appropriately ventilated c- if waste liquid produced the place should provide means of drainage that is sufficient for removal and is kept in clean working order and condition d-clean from foul odours and free from dust and creatures likely to contaminate e- walls, floors, ceilings and roofs shall be properly constructed and kept in good repair and shall be easy to clean f- not used for any purpose that might affect quality of product g- with sinks and other sanitary fittings maintained in good clean working condition h- provided with an adequate supply of hot and cold water and soap or other detergent i- wash basins and toilets in good clean working order and conditions with adequate hot and cold water, soap or other drying equipment
32
MR 32
Storage of medicines 1- Every person in possession or control of any medicine, related product or cosmetic shall at all times a- keep them clean and free from contamination by moisture, foul odours or dust and b-protect them from access by creatures likely to contaminate it 2- store and keep it packed in such a manner as to minimise its deterioration and shall comply with all requirements for storage stated on label or contained in specified publication in respect of that medicine, related product or cosmetic
33
MR36
Storage to be separate No person shall store or keep for ready use any medicine, related product, cosmetic in such manner that a food or drink may be contaminated by escape or leakage of the medicine, related product or cosmetic or release vapours
34
MR34
Exposure to toxic substances prohibited Except otherwise provided in these regulations no person shall, in the course of manufacture, storage, packing or supply of any medicine, related product, or cosmetic for sale, keep, carry, spread or use or permit to be kept, carried, spread or use, any toxic or noxious substance so as to expose medicine, related product or cosmetic to the risk of contamination by that substance at any time
35
Requirements for person handling medicines, related product and cosmetic for sale
MR26 - Person handling medicines, related product and cosmetic for sale 1- (a)includes person who is engaged or employed in the manufacture, packing, labelling, storage, or supply of any medicine related product or cosmetic for sale and (b) activity comes into direct contact with any medicine, related product or cosmetic, interior part of container containing medicine related product or cosmetic or a wrapper for... shall at all times while so engaged or employed, maintain his clothing and his person in a state of cleanliness 2-No person engaged or employed in the sale of any medicine or in manufacture, packing, labelling, storage or supply of medicine shall do any act or make any default or omission whereby that medicine becomes or is liable to become contaminated, polluted or tainted
36
MR27
Infected person No person who is suffering from a communicable disease or is a carrier or is suffering from a condition causing discharge of pus or exudate shall engage or be employed in the sale, manufacture, packing, labelling, storage or supply for sale of (a) any medicine, related product or cosmetic or (b) any material or article used or likely to be used as a wrapper or container for any medicine, related product or cosmetic
37
MR28
Persons in contact with infected persons 1- Medical Officer of Health may by notice in writing prohibit the person so served from engaging or being employed in the sale or supply of any medicine, related product, or cosmetic, or the manufacture, packing, labelling, storage 2- Where in the opinion of the Medical Officer of Health there is no longer any risk of any medicine, related product, cosmetic becoming infected by the person whom has been served shall revoke the notice, and shall notify in writing 3- No person shall: a-engage or undertake employment in any activity in contravention of notice served on him under this regulation b- knowingly employ any person in contravention of a notice served on that other under this regulation
38
MA19
Administering prescription medicines (1) A prescription medicine may be administered to any person only in accordance with a- The directions of authorised prescriber who prescribe the medicine b-A standing order (2) Despite subsection (1) a prescription medicine may be administered where permitted by section 25 or by regulations made under this Act
39
MA 28
Exemptions in respect of herbal remedies (1) Any person may in the course of a business carried on by that person, manufacture, pack, and label or sell or supply, any herbal remedy for administration to a particular person after being requested by or on behalf of that person to use his own judgement as to the treatment required (2) Any person may manufacture, pack, and label any herbal remedy, and sell or supply any herbal remedy, if the remedy is or is to be sold or supplied a- under a designation that specifies only the plant from which it is made and the process to which the plant has been subjected during the production of the remedy and b- Without any written recommendation (whether by means of a labelled container or package or a leaflet or in any other way) as to the use of the remedy
40
MA32
Exemptions for natural therapists and others Any natural therapist or other person may manufacture, pack, label, sell by retail, or supply in circumstances corresponding to retail sale, any medicine that neither is nor contains (a) A prescription medicine or (b) A restricted medicine (c) A pharmacy only medicine for administration to a particular person after being requested by or on behalf of that person to use his own judgement as to the treatment required
41
Meaning of dietary supplements
Dietary Supplements Regulations 2A (1) In these regulations, dietary supplement means something to which subclauses 2 to 6 apply (2) amino acid, edible substance, herb, mineral,synthetic nutrient, or vitamin (3) sold by itself or in a mixture (4) sold in a controlled dosage form as a liquid, powder, or tablet (which might be described on the label as a cachet, capsule, lozenge, or pastille instead of a tablet) (5) intended to be ingested orally (6) intended to supplement the amount of amino acid, edible substance, herb, mineral, synthetic nutrient or vitamin normally derived from food
42
Maximum daily doses of dietary supplements
Dietary Supplements Regulations 3 ``` (1) Copper 5mg Iron 24mg Selenium 150mcg Zinc 25mg Vitamin A or retinol 3000mcg Niacin or nicotinic acids 100mg Vitamin B12 50mcg Vitamin D 25mcg Folic 500mcg ```
43
Therapeutic claims of dietary supplements
Dietary Supplements Regulations 11 No dietary supplement or package or container containing a dietary supplement shall be advertised or labelled with a statement relating to any of the following matters: a- Treating or preventing disease b- Diagnosing disease or ascertaining the existence, degree or extent of a physiological condition c- Altering shape, structure, size, or weight of the human body d- preventing or interfering with the normal operation of a physiological function whether permanently or temporarily

Pharmacy Law (11 decks)

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