3b_Controls on Wholesalers and Retail

Question 1

what does ‘sale by wholesale’ means in the poison rule?

Answer 1

means sale in any of the circumstances set out in Section 8 of the Act (aka the Poisons Act)

Question 2

what does ‘selling…by way of wholesale dealing’ means in the Medicines Act?

Answer 2

person buys for the purpose of selling or supply in the course of a business carried on by that person

EXCEPT that it does not include any such sale by the person who manufactured it

Question 3

exemption from requirement for wholesale dealer’s license under the Medicines Act

Answer 3

• wholesale dealers of ‘herbal remedies’
• wholesale dealers of certain products specified in Medicines (Traditional, Medicines, Homeopathic Medicines and Other Substances) Exemption Order

Question 4

exemption from requirement for wholesaler’s license under the HP (TP) Regulations

Answer 4

• licensed manufacturers, when wholesaling therapeutic pdts manufactured by themselves
• licensed importer, when supplying (by export) therapeutic pdts imported solely for purpose of export
• supply to ships and aircraft, for requirements of relevant written laws
• private hospitals and medical clinics, when transferring compounded pdts to other hospitals and clinics
• pharmacies when supplying to:
  a. private hospitals and medical clinics
  b. ships and aircrafts
  c. non-clinical purposes; scientific education
  d. government department for provision of public services
  e. other pharmacy outlets under same management
  f. registered therapeutic pdts to companies outside sg (export)

Question 5

exemption from requirement for wholesaler’s license under the HP (Medical Devices) Regulations

Answer 5

• licensed manufacturers, when wholesaling medical devices manufactured by themselves
• wholesalers of medical devices licensed under the radiation protection act, wholesaling irradiating devices
• licensed importers when supplying to ships and aircraft

Question 6

exemption from requirement for wholesaler’s license under the HP (CTGT products) Regulations

Answer 6

• ‘known wholesaler’ of minimally manipulated CTGT pdts
• wholesaler of CTGT pdy not for supply to public; non-clinical purpose
• licensed or known manufacturer when wholesaling own CTGT products
• licensed importers when supplying (by export) CTGT pdts that had been imported solely for the purpose of export
• private hospitals and medical clinics, when transferring to other hospitals and clinics, CTGT pdts ordered by a qualified practitioner for his patient

Question 7

what are the pharmacy license requirement under the HP (licensing of retail pharmacies) regulations

Answer 7

• pharmacy has secure dispensing area, orderly arrangement of pdts, appropriate storage facilities
• proper system and maintenance of records
• under control and management of qualified pharmacist