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
