controls on dealers Flashcards
dealer can be engaged in more than 1 activity
true
whats the regulatory framework for health products
imposes controls on dealers , but not directly control how an individual end user actually uses the product
definition of manufacture in the medicines act
section 2
- process of making medicinal product
- not including dissolving or dispensing product in or diluting or mixing it with some other substance used as a vehicle for the purpose of administering it
( crushing tablet and mixing w vehicle for child not included )
“assemble” in medicines act
section 2
- enclosing in container labelled before product osld or supplied / if already enclosed then labelling the container before the product is sold or supplied in it
- breaking bulk is considered
“manufacture” in HPA
section 2
- make , fabricate , produce or process health produces and includes
- any process carried out in the course
- packaging and labelling before it is supplied
“compound” in HPA
therpeutic products regulations in HPA
r21
which acts have no specific controls for manufacturers
sale of drugs
poisons
medicines ( advertisement and sale) act
what are the controls on manufacturers under the medicines act
+ any exemptions if applicable
manufacturers ( inlcuding assemblers ) must be licensed s6
- licensed manufacturers must comply with “standard provisions” attached to license
-> for general manufactuers r31d in fourth schedule
+ for cpm manufacturers
exempted from needed manufacturers license
- if medicinal product is herbal , traditional , homeopathic and quasi med
AS OF NOW MEDICINES ACT ONLY CONTROLS FOR MANUFACTURERS OF CPM, REST IS CONTROLLED BY HPA
what are the controls on manufacturers under the HPA
any exemptions is applicable
section 12
- manufacturers of “health products must be licensed
- must be carried out according to license conditions
- must be at authorised premises or facility
exemptions
- cosmetic products
( ctgt medical and therapeutic all still need )
- “private hospitals” and “medical clinics” compounding therapeutic products
- “licensed retail pharmacies compounding therapeutic products
- private hosp and clinics when manufacturing “custom-made medical devices for own patients
- fitting or adjusting device for end user or enabling continued use by end-user
( as long as for a specific end user dont need license)
- “clinical laboratory” when manufacturing
- for labs own use
- any party manufacturing med devices by way of secondary assembly meaning “ breaking bulk or repacking “
- “ known manufacturers” of “minimally manipulated CTGT
- CTGT not supplied to public , only for r&d , scientific or non-clinical purpose
conditional exemption for med deices - manufacturers of class A ie low risk devices for charitable purposes like walking aids /walking frames ( can apply to hsa to be granted, not a right )
requirements for manufactuer’s license to be issued for therapeutic product manufacturing
provide and maintain staff premises, equipment, facilities for manufacture handling and storage of products
- ensure products are of correct identity and conform
with strength, quality and purity
- comply with good manufacturing practice
requirements for manufacturer’s license to be issued for med device manufacturing
provide and maintain staff premises, equipment, facilities for manufacture handling and storage of devices
- ensure devices not wrongly labelled
- comply witht he requirements of ISO13485
medicines act - import
s2- import into sg whether by land , sea or air
which acts have no specific controls for importers
sale of drugs act
medicines ( advert and sale act )
control on importers under poisons act
( applicable if HPA is not applicable)
- importers of poisons must be licensed
- licensed importers subject to terms and conditions attached to license s10
control on importers under medicines act
and exemptions if necessary
- must be licensed
- licensed importers must comply with standard provisions attached to license
exemptions
- herbal remedies
- importers of certain types of medicines ( check slide 28 )
conditional exemption
- import solely for re-export
- imported for specific name patients
- person importing limited quantity for personal use
CURRENTLY only CPM is controlled under the medicines act - import license only required for cpm under the medicines act
western meds regulated as therapeutic products under the HPA
medicines act controls in effect for what now with regards to import and manufacture
CPM only
controls for importation under the HPA
+ exemptions
section 13
- importers of “health products” must be licensed
- importation must be carried out according to license conditions
- imported goods must be stored at authorised premises or facility
exemptions
- cosmetic products
- importing limited quantities of therapeutic products for personal use
- importers of med devices licensed under radiation protection act, when importing those (irradiating ) devices
- limited qty of med device for personal use
( single use maybe 3 months, long term use then 1 )
- known importers of minimally manipulated ctgt
- licensed or known manufacturers when importing products required for manufacture of CTGT products
conditional exemptions
- importing unregistered therapeutic products for specific named patients
therapeutic products importation license requirements
applicant must be able to provide and maintain staff, premises, equipment, facilities for handling and storage of product
- must comply with good distribution practices
med device importation licensing requirements
applicant must be able to provide and maintain staff, premises, equipment, facilities for handling and storage of device
- comply w requirements of ISO 13485 or Good distribution practice for medical devices
CTGT products importation license requirements
- comply w proper storage and handling requirements
- comply w good distribution practices
wholesale definition under poisons act
sale by way of wholesale dealing s 2
and any of the ways listed out in section 8
wholesale definition in medicines act
selling by way of wholesale dealing
section2
except that it does not include any such sale by the person who manufactured it
wholesale definition in HPA
section 2
general wholesale definition
A sells to B not for B to use
determines by nature of transaction not the quantity or volume of goods involved in the transaction
which acts have no specific controls for wholesaling
sale of drugs act
medicines ( advertisement and sale) act
wholesale control under the poisons act
persons selling poisons must be licensed
- section 5 and 6
- sale must be in accordance w license conditions
at premises specified in license
by or under supervision of named license
sale by way of wholesale dealing only to persons licensed to sell poisons !!
( sell poisons need license since wholesale is for the buyer to sell to someone else, so the buyer of these poisons must also be licensed to sell )
wholesale control under the medicines act
+ exemptions
must be licensed
- must comply w standard provisions attached to license
- details spelt out in subsidiary legislation ( third schedule of medicines licensing standard provisions and fees ) regulations r3
additionally for cpm dealers too
exemptions
- herbal remedies
- traditiona, homoepathic medicine s and other substances ( in the exemption order ) slide 15 )
in effect for CPM Only as western pharm meds are regulated a therapeutic products under the HPA
wholesale control under the HPA
- must be licensed section 14
- must be carried out according to license conditions
- goods for distribution must be stored at authorised premises or facility
exempted
- cosmetic products ( just like manufacture, import no license needed
- licensed manufacturers whne wholesaling therapeutic products manufactured by themselves ( r55 of therapeutic products regulation ) - bc already assessed for storage etc
- licensed importers supplying products that had been imported soley for the purpose of export r53 ( only need to be licensed as an importer )
- licensed importer supplying to ships and aircraft r56
- hosp and clinic transferring compounded products to other hosp or clinic
- retail pharmacies supply to private hosp and med clinics ( usually small scale )
- use on ships or aircraft
- pharmacies supplying for r&d , non clinical purpose or scientific purpose, to govt dept or statutory bodies for public service provision , other pharm outlets, reg therapeutic products outside of singapore
- licensed manufactuers, when wholesaling med devices manufactuered by themselves
- wholesalers licensed under radiation protecting act
- known wholesaler of minimally manipulated CTGT products
- ctgt for r& d scientic efucation only with no clinical purpose
- licensed or known manufactuers when wholesaling own CTGT products
- licensed import , import only for export
- transfer ctgt to diff hospital or clinics
requirements of handing wholesaler license for therapeutic products
- applicant must be able to
- provide and maintain staff, premises, equipment and facilities for handling storage and distribution of products
- comply w good distribution practice
requirements for handing out wholesaler license for therapeutic products
- provide and maintain staff, premises, equipment and facilities for handling storage and distribution of devices
- comply w requirements of ISO13485 or good distirbution practide for med devices
requirements for handing out wholesaler license for CTGT
- provide and maintain staff, premises, equipment and facilities for handling storage and distribution of products
- comply w good distribution practice
retail definition
terms of what is not wholesale activity , section 2 of poisons and medicines act
relevant terms in retail
under the Health products ( licensing of retail pharmacies ) regulations
- retail pharmacy business - not qualified practitioner
- retail pharmacy services - sale or dispensing of health products
- telepharmacy service
pharmacy dept in hosp or clinic - serving internally
- qualified practitioner - doctors/dentist - run their own clinics and can supply without holding retail pharmacy license
qualified pharmacist - registered + valid PC
in store pharmaceutical officer - qualified pharmacist under superivison
which acts have no specific retail control
sale of drugs
medicines ( advertisement and sale) act
retail control under poisons act
- person selling poisons must be licensed must be pharmacist ( less relevant after 1/11/16)
retail control under medicines act
- retail pharmacist need to be registered with licensing authority ( less relevant after 1/11/16)
retail control under HPA
s17
once licensed, retail pharmacies can conduct retail pharmacy business and provide retail pharmacy services ( including telepharmacy)
requirements for pharmacy license to be handed
- retail control under HPA
- pharmacy has secure dispensing area
orderly arrangeemnt of products, appropriate storage facilities ( out of sight out of reach to geenral public + must be supplied thru a HCP ) - proper system and maintenance of records
- pharmacy will at all times be under control and management of qualified pharmacist ( have at least 1 supervising pharmacist )
r5 of health products ( licensing of retail pharmacies ) regulations
