regulations and categories of products Flashcards
define health products
broadly include all types of products used by or on humans for the purposes or reasons relation to health and well being
- wide spectrum
why are health products a special commodity
- greater consequences on public health and safety in the case of defect, deviation or failure
- diff from consumer goods
- ## not sufficient to leave entirely to free-market forces and consumer choice ( customers dont have the necessary knowledge to decide or decipher so they must be regulated )
examples of other specially regulated goods and items
food and drinks subjected to food safety laws
and
industrial chemicals subjected to environmental protection and pollution control laws
intent of the sale of drugs act
and what was it originally
what it deals with
- make better provision for the sale of drugs in a pure ststae
ensure consumers supplied with drugs that are of the quantity and quality requested by them
- consumer protection act
- originally food and drugs ordinance then split into sale of food and sale of drugs
INVOLVES TRANSACTIONAL SALE TO PROTECT THE CONSUMER/BUYER
poisons act intent
initially what
regulate the importation , posession, manufacture, compounding , storage , transport and sale of poisons
- control substances that are potentially hazardous prevent them from causing harm due to accidents or misuse
- originally included controls on industrial chemicals also
- controls on sale, supply AND importation and dealings , finished products , preperations and raw materials and ingredients
- persons handling the poison
poisons vs sale of drugs act
poisons act - controls sale, supply AND importation and dealings so wider in scope
poisons act controls applies to what
- controls on sale, supply AND importation and dealings , finished products , preperations and raw materials and ingredients
- persons handling the poison
medicines ( advertisement and sale ) act intent
and it controls
- controls ads
- curb misleading ads relating to med and med services
regulate manner in which meds are sold
controls on element of advertising itself regardless of whether there is actual sale
- narrower scope
medicines act intent
and it controls
regulate dealings in “medicinal products “ particularly concerning its safety, quality and efficacy as well as activities of the dealers concerned
- controls key activities including manufacturing importing, supply and distribution
new element of product control - the idea of it being a proprietary product
medicines act better bc
more comprehensive and
better suited for regulation of modern pharm medicines
- mass produced instead of small scale compounded
health products addresses what in the previous laws
- control for other products like med devices
( prev geared towards western type pharmaceutical meds ) - ability to regulate emerging new types of products
- ability to regulate new forms of older types of older products eg high tech herbal meds
- combines all the prev acts bc was spread out and controls were fragmented and overlapping , reduces administrative burden on the industry as a regulator
- diff levels of control applied according to the respective risk profile , avoid one size fits all system of control
- includes cosmetic purposes which medicines act did not cover
health products controls on
- products already regulated eg meds
- those not yet regulated like med devices
- new emerging products
- controls on dealers, advertising and product control
constituitionally HPLs come under the charge of ?
Minister of Health
in practice HPLs administered and enforced by?
HSA
subsidiary legislation made by
Minister, HSA with the approval of the minister
what is the term used in the sale of drugs act
- what is it defined as
“drug” in section 2 of sale of drugs act
- substance used by man as a medicine , including anaesthetics
- if not used for medicine then not considered a drug
- includes face powders, dusting powders and toilet preperations even if not advertised or described as a drug
what is the term used in the poisons act
- what is it defined as
“poison”
- substance specified in the poisons list ( the schedule )
as long as not in the list not considered a poison regardless of how potent - including raw compound as long as can detect it , the source dosent matter
what is the term used in the medicines ( advertisement and sale) act
- what is it defined as
“substance recommended as a medicine “
- substance referred to in terms which calculated to lead to its use for the prevention or treatment of any ailment , infirmity or injury affecting the human body
but if its used as a food or drink then it is not a drug
what is the term used in the medicines act
- what is it defined as
“medicinal product”
- any substance manufactured sold, supplied or imported or exported for use for a medicinal purpose
“medicinal purpose” defined as
- treating or preventing disease
- diagnosing disease or ascertaining a physiological condition
- contraception
- inducing anaesthesia
- others
does not include
- med devices and equipment ( if dosent go into the body)
- new substances in early R&D
- dental fillings and materials
- plain bandages and surgical dressings, not containing medication
- other items specified by the minister
subsets of medicinal product
- CPM
- traditional med
- quasi-medicinal product
- medicated oil and balm
- homeopathic medicine
what is the term used in the HPC
-what is it defined as
“health product”
- substance prep or device solely or principally for a health-related purpose AND falls into one of the categories :
med devices, cosmetics, therapeutic products, oral dental gums and cell,tissue or gene therapy products
“health related purpose” meaning
-> therapeutic, preventive, palliative, diagnostic or cosmetic purpose, or any other purpose for the promotion or preservation of human health and well-being
“med devices” , “ therapeutic products” or “CTGT products “ are controlled under which act and why
HPA ,
any of these 3 which contain poisons are still regulated by HPA , bc they are exempted from the poisons rule
- in 2nd schedule
if a medicinal product under the medicines act is also a therapeutic product under the HPA?
medicines act no longer applies
” pharmaceutical products “
- informal term !
1. “ pharmaceutical products” - refer to western type medicines
- mostly have chemical active ingredients or biologic products eg vaccines
- have clear purpose and indications
“complementary medicines”
complementary or as alternative to mainstream pharm meds
- generally thought to include
- traditional herb medicines w/o synthetic chemicals
- supplements to supplement health but not to treat diseases or med conditions
” med devices and equipment “
informal term
- generally thought to include products that
- not substances or preperations
- will not be metabolised by human body
what to note about the informal terms
- not to be used as substitutes for proper categorisation
- use the proper legal definitions
which act has subsets of the term
medicines act and HPA
- hpa’s will only come into effect if the product falls into one of the categories
