pre market controls & retail control Flashcards
what makes a product unique
product name
formulation or design ingreidnets, strength m dosage form
indications
manufacturer
which acts have no product controls
sale of drugs
poisons
medicines advert act
medicines act product control
- must have product license , assessed on safety, efficacy and quality , assigned a SIN number ( not as relevant anymore )
- mainly CPM exempted from requiring license but must be submitted to licensing authority for assessment of safety and quality
herbal remedies also exempted
who can deal cpm products
licensed cpm dealers can only deal listed cpm products
- manufacture listed products
import listed products and
wholesale dealers can only sell listed products
HPA product controls
- registration needed
hsa maintains list of registered products
hsa may attach conditiosn to products registration
not for cosmetic ! ( TP, MD and CTGT need )
therapeutic products product registration requirement s
- benefits outwieght risks
- product suitable for intended purpose, risk minimised
- those compounded r exempted
- products for named patients
- imported for personal use
- intended for ships or aircradt
- solely for export or import solely for re-export
- non clinical purpose
MD product registration
MD assigned to diff classes based on risk level class A lowest CLass D highest according to critera in 3rd scheudle - invasive or non activepowered vs non-powered
and registration is needed for b,c,d A is exempted from
registration
exeptions
- made in hosptials for patients
- lab-developed tests manufactuered by clinical lsbs
- custom made med devices
- for specifc patients
- for export or import solely for re-export
- non clinical purposes
CTGT product registration
2 classes of ctgt , ctgt are class 2 by default
class 1 - minimally manipulated, homolgous use , not used w therapeutic product or MD
class 2 can be registered if hsa satisified - if overall benefit outweighs the risk product suitable for intended purpose class 2 requires registration
class 1 exempted but must give hsa notice and receive hsa’s acceptance of notification
exemptions
- named patients
- for r&d
- for export solely or re-export solely
cosmetic products product registration
“notification requirement “
- party responsible for placing it in the market but
- notify hsa before starting to supply the product
- further notify hsa annually for as long as it continues to supply the product
this is in line w cosmetic-products asian cosmetic directive regulations r4
in line w sg obligation under ASEAN cosmetic directive
- not the same as registration/licensing system - regulatory approval not required.
retail access applicable to
therapeutic and CTGT
no restrictions on cpm, trad, quasi , cosmetic
which acts have no controls for retail level access
sale of drugs
meds ( adv and sales ) act
retail level control under poisons act
sold or supplied only by licensed person or hcp
less relevant after 1 nov 2016
retail level control for medicines act
non GSL products can be sold or supplied only in retail pharmacies
( less relevatn after 1 nov 2016)
retail level control under hPA
and gsl
- each product registered under 3 classes, gsl, p, pom
gsl - eg aspirin, paracetemol, antacids
can be used without hcp
can be supplied by retail freely without restriction
suuplied thru vending machine subject to requirements
like storage conditions in machine, packaging and labelling must be suitable
p items control
more potent
under supervision of hcp
can be supplied in retail pharmacies ,subject to requirements
- by “ in store pharmaceutical officer”
- licensed healthcare institutions to their own patients in accordance w written instructions of practitioner in instituition
by practitioners to their own patients
