Decision

22 December 2014: promotion of medicines by Galderma

Published 8 April 2015

A healthcare professional complained to MHRA about promotional activities carried out by Galderma staff. The complainant was concerned that the manager who authorised distribution of samples of medicines was not qualified to carry out their role and that a nurse trainer promoted unlicensed uses of their botulinum toxin product, Azzalure.

MHRA did not uphold the complaint. Galderma demonstrated that they had written procedures for the supply of samples, including vials used in training, that complied with the legal requirements. Documentation relating to the services provided by the nurse trainer was found to refer to the licensed use of botulinum toxins only and Galderma provided assurances that the individual had been trained on, and follows, the legal requirement to discuss the use of medicines within the licensed indications only.