§ Mr. HinchliffeTo ask the Secretary of State for Health what steps his Department has taken to evaluate the risks from gamma globulin used in the preparation of Hepatitis A passive immunisation. [17232]
§ Ms JowellThe marketing authorisation (the licensing) of all medicines throughout the European Union is governed by the Rules Governing Medicinal Products in the European Union, in particular, Council Directive 65/65/EEC.
All licensed normal intra-muscular immunoglobulin (used for passive immunisation for Hepatitis A) has been fully evaluated for quality, safety and efficacy. These products have not been associated with the transmission of any infection.