10 January 2019: Patient Guide for Oralvac by Allergy Therapeutics (UK) Ltd
Updated 14 May 2019
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ALK-Abelló Ltd complained about a Patient Guide for Oralvac produced by Allergy Therapeutics. The complainant alleged that the material was issued to healthcare professionals with the intention that it was given to patients considering immunotherapy and that this constituted promotion of an unlicensed medicine.
The MHRA did not uphold the complaint. Allergy Therapeutics assured the MHRA that, whilst Oralvac was an unlicensed medicine, it was supplied only to healthcare professionals (HCPs) who had made an unsolicited request for Oralvac in order to meet the needs of individual patients under Regulation 167 of the Human Medicines Regulations 2012 and that the Patient Guide, containing patient friendly information about the correct use of the product, was provided to be given to these patients.