Question 1 In 300 to 600 words, with reference to the relevant Act(s) or guidelines, explain how Singapore’s pharmaceutical legislation has affected the operations in the organisation that you are currently working at. (Dental clinics) Health Products Act • Medicines Act • Misuse of Drugs Act • Poisons Act. Question 2 Product L is one of the products kept in your organisation. Today, Singapore Authority announces that all batches of Product L are to be returned from your organisation to the local distributor due to the presence of undeclared substance, i.e. nitrosamine impurity, N-nitroso-N-methyl-4-aminobutyric acid (NMBA) in one of the batches. NMDA will not cause immediate life-threatening effect but may lead to certain heart conditions in long term exposure. With reference to the relevant Act(s), in 200 to 400 words, explain and elaborate: – the roles of each involved parties (including yourself) in this incident, – the next course of action, including the extent and urgency to return the goods, – the documentations or records required in this incident, – the impact to your organisation. Question 3 Select one generic or innovator product that you have come across in your organization. In 200 to 400 words, compare and contrast your chosen product with another innovator or generic brand that consists of the SAME active pharmaceutical ingredient, in terms of their legislative characteristics and/or HSA application, with reference to the relevant Act(s) and guidelines. Reference(s), where applicable: I need 3 question reference(s)
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