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Legislation June 2018
Introduction
Introduction
Question 1 - Drug Classification
Question
a) 1mg tablet of selexipag
b) tablet containing 6.14 mg tipiracil and 15 mg trifluridine
c) A syrup containing 1.8 mg/5ml promethazine hydrochloride, 4.5 mg/5ml codeine phosphate, 3.6 mg/5ml ephedrine hydrochloride (Updated Jan 2024)
d) An ointment containing 2% mupirocin
e) 5% amorolfine nail laquer
f) A tablet containing 100mg allopurinol
g) An inhaler containing 200 mcg/puff of ipratropium bromide
h) A vial of solution for injection containing 0.45% sodium chloride
i) A tablet containing 70 mg alendronate sodium
j) An eye drop containing 1 mg dexamethasone phosphate sodium and 3.5 mg neomycin sulfate per 1ml
k) A tablet containing 10 mg bambuterol hydrochloride
l) A tablet containing 2 mg of lorazepam
Part 2 Poisons
Question 2 - Dangerous drugs and ASPs
Question
Answer
Question 3 - Undesirable Medical Advertisements Ordinance
Question
a) Definitions
b) Prohibitions and exceptions of advertisements
Question 4 - Pharmaceutical Products
Question
a) Definition
b) Registration requirements
c) Clinical trials
Question 5 - Manufacturing
Question
a) Definitions
b) Labelling, duties and record keeping
c) Authorised person
j) An eye drop containing 1 mg dexamethasone phosphate sodium and 3.5 mg neomycin sulfate per 1ml
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