Medicines and Healthcare Products Regulatory Agency

The complainant has requested information relating to reports of adverse incidents submitted to the Medicine and Healthcare Products Regulatory Agency (MHRA) from 1 April 2003 to 30 March 2017. The Commissioner’s decision is that MHRA has incorrectly applied section 14(1) to the request. The Commissioner requires MHRA to take the following steps to ensure compliance with the legislation. Issue a fresh response without reliance on section 14(1). The public authority must take these steps within 35 calendar days of the date of this decision notice. Failure to comply may result in the Commissioner making written certification of this fact to the High Court pursuant to section 54 of the Act and may be dealt with as a contempt of court.