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PR3146 > controls on dealers > Flashcards

controls on dealers Flashcards

1
Q

dealer can be engaged in more than 1 activity

A

true

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2
Q

whats the regulatory framework for health products

A

imposes controls on dealers , but not directly control how an individual end user actually uses the product

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3
Q

definition of manufacture in the medicines act

A

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 )
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4
Q

“assemble” in medicines act

A

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
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5
Q

“manufacture” in HPA

A

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
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6
Q

“compound” in HPA

A

therpeutic products regulations in HPA

r21

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7
Q

which acts have no specific controls for manufacturers

A

sale of drugs
poisons
medicines ( advertisement and sale) act

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8
Q

what are the controls on manufacturers under the medicines act

+ any exemptions if applicable

A

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

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9
Q

what are the controls on manufacturers under the HPA

any exemptions is applicable

A

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 )
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10
Q

requirements for manufactuer’s license to be issued for therapeutic product manufacturing

A

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

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11
Q

requirements for manufacturer’s license to be issued for med device manufacturing

A

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
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12
Q

medicines act - import

A

s2- import into sg whether by land , sea or air

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13
Q

which acts have no specific controls for importers

A

sale of drugs act

medicines ( advert and sale act )

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14
Q

control on importers under poisons act

A

( applicable if HPA is not applicable)

  • importers of poisons must be licensed
  • licensed importers subject to terms and conditions attached to license s10
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15
Q

control on importers under medicines act

and exemptions if necessary

A
  • 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

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16
Q

medicines act controls in effect for what now with regards to import and manufacture

A

CPM only

17
Q

controls for importation under the HPA

+ exemptions

A

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

18
Q

therapeutic products importation license requirements

A

applicant must be able to provide and maintain staff, premises, equipment, facilities for handling and storage of product
- must comply with good distribution practices

19
Q

med device importation licensing requirements

A

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
20
Q

CTGT products importation license requirements

A
  • comply w proper storage and handling requirements

- comply w good distribution practices

21
Q

wholesale definition under poisons act

A

sale by way of wholesale dealing s 2

and any of the ways listed out in section 8

22
Q

wholesale definition in medicines act

A

selling by way of wholesale dealing

section2

except that it does not include any such sale by the person who manufactured it

23
Q

wholesale definition in HPA

A

section 2

24
Q

general wholesale definition

A

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

25
Q

which acts have no specific controls for wholesaling

A

sale of drugs act

medicines ( advertisement and sale) act

26
Q

wholesale control under the poisons act

A

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 )

27
Q

wholesale control under the medicines act

+ exemptions

A

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

28
Q

wholesale control under the HPA

A
  • 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
29
Q

requirements of handing wholesaler license for therapeutic products

A
  • 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
30
Q

requirements for handing out wholesaler license for therapeutic products

A
  • 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
31
Q

requirements for handing out wholesaler license for CTGT

A
  • provide and maintain staff, premises, equipment and facilities for handling storage and distribution of products
  • comply w good distribution practice
32
Q

retail definition

A

terms of what is not wholesale activity , section 2 of poisons and medicines act

33
Q

relevant terms in retail

A

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

34
Q

which acts have no specific retail control

A

sale of drugs

medicines ( advertisement and sale) act

35
Q

retail control under poisons act

A
  • person selling poisons must be licensed must be pharmacist ( less relevant after 1/11/16)
36
Q

retail control under medicines act

A
  • retail pharmacist need to be registered with licensing authority ( less relevant after 1/11/16)
37
Q

retail control under HPA

A

s17

once licensed, retail pharmacies can conduct retail pharmacy business and provide retail pharmacy services ( including telepharmacy)

38
Q

requirements for pharmacy license to be handed

- retail control under HPA

A
  • 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

PR3146 (12 decks)

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