Question

(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)

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