Why is there a need for particular care to be taken around extremes of format, size or cost in the first six months following the launch of a medicine?

  • 9.7

    9.7 Extremes of format, size or cost of material must be avoided.

    Informational or educational materials must be inexpensive, directly relevant to the practice of medicine or pharmacy and directly beneficial to the care of patients.

  • 11.2

    11.2 Restraint must be exercised on the frequency of distribution and on the volume of promotional material distributed.

The supplementary information to Clause 9.7, Extremes of Format, Size or Cost, states that particular care needs to be taken in this regard in the first six months following the launch of a medicine to avoid criticism of the industry.

Extremes of format, size and cost of material must be avoided at all times; it is really important to make sure the impression created is appropriate. This is applicable at all times however particular care should be taken during the first six months following launch as this is often a time when companies wish to post out mailings at a higher frequency. During this time companies may post out 4 mailings in total (supplementary information to 11.2 applies).

Guidance
2021 Q&As by Topic OR Clause