presentation & labelling Flashcards
what are the requirements for labelling of posions
- Poisons act: s6(2)
- Poisons rules: r20
what are the requirements for the labelling of ‘substances recommended to disclose their composition’
s7 of the Medicines (Adv and Sale Act)
- appropriate designation and appropriate quantitative particulars
what are the requirements for labelling CPM pdts
Medicines (Labelling of CPM) regulation: r3(2), r9, r6
what are the labelling requirements for TP that needs to be dispense by a pharmacist
r17(1) of HP (TP) regulation
what are the labelling requirements for TP that are non-dispensing = GSL/OTC?
r20(1),(2),(3) of HP (TP regulation
- take note of the ‘or’ and ‘and’
what are some labelling/presentation prohibition of HP
r19 of HP (TP) regulations
- false or misleading info
- cannot say its promoted or endorsed by HSA or HPB or MOH
what are the labelling requirements for CTGT pdts
r26(1) of HP (CTGT) reg
what are the labelling requirements for CTGT that are non-dispensing
r25(1) of HP (CTGT) reg
for dispensed TP or CTGT, what name(s) must I put
EITHER proprietary or non-proprietary
for non-dispense/OTC TP or CTGT what name(s) must I put
BOTH proprietary and non-proprietary
preservatives and other excipients labelled
what are the labelling requirements of medical devices
r15 of HP (Medical Devices) Regulation
what are some labelling prohibition for medical devices
r14 of HP (Medical devices) Regulation
- false/misleading
- say that its promoted or endorsed by HSA
- change/modify presentation of device, which is not of product owner’s specification
what are the labelling requirements for cosmetic products?
- r7 of HP (Cosmetic products -ACD) regulation
what are some labelling prohibition for cosmetic products
- r8 of HP (Cosmetic products -ACD) regulation
- cannot say promoted or endorsed by HSA
- cannot create erroneous impression on its formulation, quality or safety
