1. (A) Indicate by using the abbreviations respectively shown in square brackets, the legal classifications of the following drugs showing whether they are included in Part 1 of Schedule 10 to the Pharmacy and Poisons Regulations [P1], Part 2 of Schedule 10 to the Pharmacy and Poisons Regulations [P2], Schedule 1 to the Pharmacy and Poisons Regulations [S1], Schedule 3 to the Pharmacy and Poisons Regulations [S3], Part I of Schedule 1 to the Dangerous Drugs Ordinance [P1DD], Part II or Part III of Schedule 1 to the Dangerous Drugs Ordinance [P2DD], Schedule 1 to the Antibiotics Regulations [A], or none of the above [NP]: 

(1 mark each) 

(a) A lotion containing 8% w/v calamine, 1% w/v diphenhydramine hydrochloride and 0.1% w/v camphor 

(b) A tablet containing 8mg bromhexine hydrochloride 

(c) A tablet containing 7.5mg zopiclone 

(d) A tablet containing 2mg melphalan 

Note: Structure of melphalan is 

(e) A nasal ointment containing 2.8g/100g sodium chloride and 7.2g/100g sodium bicarbonate 

(f) A syrup containing 1.25mg/5ml triprolidine hydrochloride, 30mg/5ml pseudoephedrine hydrochloride and 10mg/5ml dextromethorphan hydrobromide 

(g) An injection containing 300mg/2ml anifrolumab 

(h) A cream containing 2% w/w fusidic acid and 1% w/w hydrocortisone acetate 

(i) A suspension containing 1000mg/5ml kaolin and 55mg/5ml pectin 

(j) A syrup containing 25mg/5ml codeine phosphate 

(k) A tablet containing 0.035mg ethinyloestradiol and 2mg cyproterone acetate 

(l) A capsule containing 250mg thiamphenicol 

Note: Structure of thiamphenicol is 



(B) Describe the specific conditions under which the following substances

are NOT controlled as Schedule 3 poisons under the Pharmacy and Poisons Regulations: 

(1 mark each) 

(a) Beclomethasone 

(b) Minoxidil 

(c) Tromantadine 

(d) Clobetasone butyrate 

(C) Describe the specific conditions under which the following poisons would be exempted from the provisions of the Pharmacy and Poisons Ordinance as stipulated under regulation 8 of the Pharmacy and Poisons. Regulations: (1 mark each)

(a) Disulfiram 

(b) Chloroform 

(D) Describe the specific conditions under which the following Part 1 poisons would be considered as Part 2 poisons under the Pharmacy and Poisons Regulations: (1 mark each) 

(a) Loratadine 

(b) Clotrimazole 

2. (a) Define "pharmaceutical product" under the Pharmacy and Poisons Ordinance. 

(3 marks) 

(b) Describe the registration requirements, exemptions, and factors relevant to determination of application for registration of pharmaceutical products as stipulated under the Pharmacy and Poisons Regulations. (12 marks) 

(c) Describe the labelling requirements with respect to pharmaceutical products for human parenteral administration containing sodium chloride 0.9% as active ingredient. (5 marks) 

3. (a)  Define "dangerous drug" and "authorized seller of poisons" under the Dangerous Drugs Ordinance. Describe the statutory authority for authorized sellers of poisons to manufacture and retail Dangerous Drugs well as the statutory requirements on keeping of register or other records by authorized sellers of poisons under the Dangerous Drugs Regulations. (10 marks) 

(b) Describe the requirements with respect to prescriptions prescribing a dangerous drug. (10 marks)

4. (a) Define "advertisement", "medicine" and "orally consumed product" under the Undesirable Medical Advertisements Ordinance on the advertising of medicines. (4 marks) 

(b) Describe the regulation of advertisements relating to "orally consumed product" as stipulated by the Undesirable Medical Advertisements Ordinance. (16 marks) 

5. (a) Define "advanced therapy product", "gene therapy product”, “somatic cell therapy product" and "tissue engineered product" under the Pharmacy and Poisons Ordinance. (12 marks) 

(b) Describe the labelling requirements for an advanced therapy product, which is a Schedule 3 poison, to be supplied in Hong Kong as stipulated under the Pharmacy and Poisons Ordinance and its Regulations. (8 marks)