general prohibitions and post market duties

Question 1

prohibition is applicable regardless of whether

Answer 1

product fulfilled any prevailing pre market regulatory requirements like being registered
- product complied with prevailing controls necessary for dealings eg licensed

Question 2

sale of drugs act prohibits ___

Answer 2

s10 and 15 of act

Question 3

medicines act general prohibitions

Answer 3

found in subsidiary legislation
p3,4,5 and schedule 1 and 2

• expired medicinal products
• substandard products
• products with THMs ( toxic heavy metals ) , could contaminate products , accumulate in body and cause toxicity
• any compound of mercury
• cpm w microbial content
• cpm w poisons except if naturally present - schedule

Question 4

health products act general prohibitions

Answer 4

r16 , definitions in the interpretations

Question 5

cosmetic products must be __ to be considered wholesome

Answer 5

comply w the requirements specified in r6 and third schedule of the health products ( cosmetic products ACD) regulations

Question 6

what is the purpose of post market duties

and some examples

Answer 6

ensure dealers have continued responsibility to help ensure the safety of their products circulating in the market

• monitor reports of adr or defects
• alert regulatory authorities of any reports or info obtained
• investigate resports of ADR or defects concerning their products and report findings to regulatory authorities
• suspend sales and recall stocks of affected products already in the mkt
• take corrective actions to rectify defects and to prevent future recurrence

Question 7

which acts do not have controls for post market duties

Answer 7

sale of drugs
poisons
meds ( ad and sale )

only meds act and hpa have controls

Question 8

difference in controls between meds act and hpa
with regards to post market conctrols

some examples under HPA

Answer 8

under meds act :

• control only by means of standard provisions and conditions attached to license
• only applicable to license holders ( but many dealers not required to have license ) so those exempt from having license not subjected to comply !

under HPA

• irregardless of the licensing system
• imposed regardless of licensing status of dealer

and under hpa :
=> report cases of defects and adverse effects
- recall stocks of affected products from market when directed by HSA
- suspend manufacture , import or supply of affected products when directed by HSA vq

Question 9

what are the main steps or obligations for all 4 types of health products

Answer 9

• keep records of all complaints adr or defects
• report cases of defects and adr to hsa within specified time
• inform hsa of any intended recall
• report to hsa on progess findings and outcome of any recall

Question 10

whats special about medical devices

Answer 10

field corrective action - going to repair the device like ct scan
- need ot inform hsa before and after ( counterpart to recall )