Robert Flello – 2015 Parliamentary Question to the Department of Health

The below Parliamentary question was asked by Robert Flello on 2015-02-20.

To ask the Secretary of State for Health, pursuant to the Answer of 10 February 2015 to Question HL4441, whether the Human Fertilisation and Embryology Authority imposed sanctions on clinics that had administered reagents to permitted gametes or permitted embryos that are then introduced into patients when the reagents concerned had not been CE marked; and when the Medicines and Healthcare products Regulatory Agency was notified of such instances documented in inspection reports.

Jane Ellison

The Human Fertilisation and Embryology Authority has advised that it has not been necessary to impose any regulatory sanctions in relation to the use of non CE marked reagents or products, as the clinics in question have given a commitment, as part of the inspection process, to use alternative CE marked products. The Medicines and Healthcare products Regulatory Agency is not notified of individual instances as reported in inspection reports, as its responsibilities relate to the manufacturers of these products not the users.