§ Mr. HinchliffeTo ask the Secretary of State for Health when his Department received advice from the Committee on the Safety of Medicines concerning the sourcing of materials from cattle under six months from BSE—free herds; what steps were subsequently taken as a result of this advice; and when. [27980]
323W
§ Mr. HoramIn February 1989, at the request of the Licensing Authority, the Committee on the Safety of Medicines, the Committee on Dental and Surgical Materials and the Veterinary Products Committee, convened an expert group to formulate guidelines on the sourcing of bovine materials for the use in the manufacture of medicinal products. These guidelines were considered and agreed by the CSM at its February 1989 meeting. The guidelines recommended that source animals should be calves up to six months of age. A letter containing these joint CSM-VPC Guidelines was sent to the pharmaceutical industry. The industry was asked to provide information on the source and type of material of animal origin used in the manufacture of medicines. Subsequently, the bovine spongiform encephalopathy working party was established jointly by the CSM and VPC. This group considered the replies from companies at its October 1989 and subsequent meetings. Companies changed their source of bovine materials to non-UK sources for parenteral, ocular and topical products applied to broken skin. All products licensed since the 1989 CSM-VPC guidelines were issued, and the subsequent European Committee on Proprietary Medicinal Products 1992 guidelines, which replaced them, have been assessed in accordance with the guidelines for the acceptability of the bovine materials used.