Post-Market Duties & Obligations

Question 1

Limitation of post-market duties & obligations under Medicines Act

Answer 1

Can only be applied to license holders. Hence, those exempted from licensing cannot be compelled to comply in this manner.
Health Product Act overcome this shortcoming.

Question 2

Under HPA, who are responsible for post-market duties & obligations?

Answer 2

Registrant, manufacturer, importers & suppliers of their health products

Question 3

Post-market duties & obligations (Therapeutic Products)

Answer 3

1. Record all defects and ADR
2. Report all defects and ADR to HSA within specified period
3. Inform HSA of any intended recall
4. Investigate (when directed by HSA) the matter that caused the recall and report findings to HSA

Question 4

Post-market duties & obligations (CTGT)

Answer 4

1. Record all defects and ADR
2. Report all defects and ADR to HSA within specified period
3. Inform HSA of any intended recall
4. Investigate (when directed by HSA) the matter that caused the recall and report findings to HSA

Question 5

Post-market duties & obligations (Medical Devices)

Answer 5

1. Record all complaints received about their medical devices
2. Report all defects and ADR to HSA within specified period
3. Inform HSA of any intended recall
4. Investigate (when directed by HSA) the matter that caused the recall and report findings to HSA
5. Inform HSA of any intended “field safety corrective action”
6. Report to HSA the progress and outcome of any “field safety corrective action”

Question 6

Post-market duties & obligations (Cosmetic Products)

Answer 6

1. Report all defects and ADR to HSA within specified period