1 Classification

A: 1 mark each

a) A tablet containing 40 mg baloxavir marboxil

b) A gel containing 0.5% lignocaine

c) A syrup containing 4mg/5ml codeine phosphate, 4 mg/5ml ephedrine HCl and 2 mg/5 ml promethazine HCl

d) A solution containing 10% povidone iodine

e) A gel containing 0.5% piroxicam

f) A tablet containing 5 mg levocetirizine

g) A solution containing 100mg/ml of citicoline

h) A suppository containing 2.5 mg cinchocaine and 100 mg policresulen

i) A shampoo containing 2 % ketoconazole

j) An eye drop containing 0.5% chloramphenicol and 0.1% dexamethasone

k) An inhaler containing 2.5 mcg olodaterol and 2.5 mcg tiotropium

l) A capsule containing 25 mg amfepramone

Note the structure of amfepramone is:

m) A vial of solution containing 10% calcium gluconate for human parenteral administration.

B: Describe the specific conditions under which the following Part I poisons would be considered as Part 2 poisons under the Pharmacy and Poisons Regulations:

a) Terbinafine (3 marks)

b) Nicotine (3 marks)

c) Loratadine (1 mark)

2. (20 marks)

a) Define "sale by way of wholesale dealing" under the Pharmacy and Poisons Ordinance.

b) Who can sell or supply, by way of wholesale dealing, a pharmaceutical product as provided under the Pharmacy and Poisonous Regulations?

c) If a company wishes to import a pharmaceutical product, what license(s) does the company require? After the company imports the pharmaceutical product, to whom it can supply if the product is a Part I poison?

3 (20 marks)

a) Define “medicine” under the Pharmacy and Poisons Ordinance.

b) Describe the labelling requirements for a medicine to be supplied in Hong Kong as stipulated under the Pharmacy and Poisons Ordinance and its Regulations. If the medicine is for exports purpose, what labelling requirements apply?

c) What additional labelling requirements apply if the medicine

i) is a lotion

(ii) is for the treatment of an animal;

(iii) contains a Part 1 poison (except Schedule 3 poison); and

(iv) contains a Schedule 3 poison?

4 (20 marks)

Describe the statutory requirements stipulated under the Dangerous Drugs Ordinance in relation to the storage, supply and record keeping of dangerous drugs by an authorised seller of poisons.

5 (20 marks)

a) Define “advertisement”, “medicine“ and “orally consumed products“ under the Undesirable Medical Advertisements Ordinance on the advertising of medicines.

b) Describe the regulation of advertisements relating to “orally consumed product“ as stipulated by the Undesirable Medical Advertisements Ordinance.