presentation & labelling

Question 1

what are the requirements for labelling of posions

Answer 1

• Poisons act: s6(2)

- Poisons rules: r20

Question 2

what are the requirements for the labelling of ‘substances recommended to disclose their composition’

Answer 2

s7 of the Medicines (Adv and Sale Act)

• appropriate designation and appropriate quantitative particulars

Question 3

what are the requirements for labelling CPM pdts

Answer 3

Medicines (Labelling of CPM) regulation: r3(2), r9, r6

Question 4

what are the labelling requirements for TP that needs to be dispense by a pharmacist

Answer 4

r17(1) of HP (TP) regulation

Question 5

what are the labelling requirements for TP that are non-dispensing = GSL/OTC?

Answer 5

r20(1),(2),(3) of HP (TP regulation

• take note of the ‘or’ and ‘and’

Question 6

what are some labelling/presentation prohibition of HP

Answer 6

r19 of HP (TP) regulations

• false or misleading info
• cannot say its promoted or endorsed by HSA or HPB or MOH

Question 7

what are the labelling requirements for CTGT pdts

Answer 7

r26(1) of HP (CTGT) reg

Question 8

what are the labelling requirements for CTGT that are non-dispensing

Answer 8

r25(1) of HP (CTGT) reg

Question 9

for dispensed TP or CTGT, what name(s) must I put

Answer 9

EITHER proprietary or non-proprietary

Question 10

for non-dispense/OTC TP or CTGT what name(s) must I put

Answer 10

BOTH proprietary and non-proprietary

preservatives and other excipients labelled

Question 11

what are the labelling requirements of medical devices

Answer 11

r15 of HP (Medical Devices) Regulation

Question 12

what are some labelling prohibition for medical devices

Answer 12

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

Question 13

what are the labelling requirements for cosmetic products?

Answer 13

• r7 of HP (Cosmetic products -ACD) regulation

Question 14

what are some labelling prohibition for cosmetic products

Answer 14

• r8 of HP (Cosmetic products -ACD) regulation
• cannot say promoted or endorsed by HSA
• cannot create erroneous impression on its formulation, quality or safety