Decision

April 2019: Promotion of an unlicensed medicine by Aclardian Limited

Updated 24 May 2019

The MHRA became aware of a brochure available at an Aclardian trade stand at the Neonatal & Paediatric Pharmacists Group conference in November 2018 that provided information on a branded unlicensed medicine, available as a ‘special’.

Aclardian provided assurances that the material was not freely available at the stand, and was provided only in response to specific and unsolicited requests from registered customers or healthcare professionals.

However, the MHRA considered that the brochure contained detailed claims about the benefits of the product that went beyond that required for factual responses to unsolicited questions. Aclardian withdrew the brochure and said that they would ensure that material made available in response to future unsolicited requests is of a non-promotional nature and is limited to that required to answer the specific question asked.