Question

Which ONE of the following is CORRECT? Sponsors of medicines registered or listed on the Australian Register of Therapeutic Goods DO NOT need to report serious adverse drug reactions (ADRs) to the Australian Therapeutic Goods Administration (TGA) if:

Select one:

a. the medication was withdrawn from sale

b. the ADR occurred in Australia but was reported in the International scientific literature

c. the ADR occurred in a post registration trial in which the medication was combined with another medication

d. there is no plausible temporal or causal association with the medicine

e. the ADR occurred in relation to an overdose of the medication

Answer 1

Answer

The answer is option D- there is no plausible temporal or causal association with the medicine.

Option D is correct because, according to the Australian Therapeutic Drugs Administration, if any serious adverse effect has occurred, which has no association with the medicine, and then no need to report it to them. As per their rules, expected and unexpected adverse reactions associated with the use of the medicine, serious adverse reactions associated with the use of the medicine that occurred in Australia but was reported in the International scientific literature and all clinical and medically relevant follow-up information related to serious adverse reaction report occurring in Australia must report to them.