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Legislation December 2022
Drug Classification
Question 1 - Drug Classfication
a) A lozenge containing 2.4 mg hexylresorcinol
b) A tablet containing 50 mg phenazopyridine hydrochloride
c) A tablet containing 100 mg allopurinol
d) A topical gel containing 10% etofenamate
e) A cream containing 50 mcg/g trifarotene
f) Syrup containing promethazine, ephedrine and codeine (Updated Jan 2024)
g) An ear drop containing 5 mg/ml hydrocortisone, 2 mg/ml chloramphenicol and 25 mg/ml phenazone
h) A tablet containing 10mg methylphenidate hydrochloride
i) A tablet containing 20mg ponesimod
j) A tablet containing 450mg diosmin and 50mg hesperidin
k) A tablet containing l00mg lacosamide
l) A capsule containing 500mg paracetamol and 30mg lysozyme
B - Schedule 3 exemptions
C - Schedule 2
Question 2 - Advanced Therapy Products
Question
a) Somatic cell therapy product and tissue engineered product
b) Substantial manipulation
c) Labelling
Question 3 - Wholesale Dealers and Manufacturers
Question
a) Definitions
b) Supply
Question 4 - Antibiotics Ordinance
Question
a) Antibiotics
b) Possession, sale and supply
c) Record-Keeping
Question 5 - Labelling
Question
a) Definition of medicine
b) Labelling requirements
c) Additional labelling requirements
a) Somatic cell therapy product and tissue engineered product
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