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type: Answer
type: WrittenAnswer
answer has question: FRkbqJys
answer has answering person: ueCA7LxD
answer text: The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the Department of Health responsible for the regulation of medicines and medical devices on the United Kingdom market, to ensure that they are acceptably safe, are efficacious/work properly and manufactured to agreed standards of quality.Well-established procedures are currently in place to ensure that new safety concerns over pharmaceutical products arising within one European Union member state are shared promptly throughout Europe. The potential risk to public health of the issue dictates how quickly and by which route this occurs.All safety reviews for products authorised in more than one member state of the EU are shared at the Pharmacovigilance Working Party of the Committee for Medicinal Products for Human Use. This is to achieve a consensus on the need for regulatory action to minimise risk to patients and to co-ordinate implementation. The UK is fully represented at these discussions.The pharmaceutical legislation within Europe has recently been substantially revised to strengthen pharmacovigilance systems. This will further clarify the roles and responsibilities of all parties and ensure that decisions on safety issues concerning pharmaceuticals are made to a timescale commensurate with the risk to public health and that communications are co-ordinated across the EU.The MHRA also acts as the National Competent Authority for medical devices in the UK. The European medical devices directives require all Competent Authorities in the EU to operate a vigilance system for the reporting of adverse incidents involving medical devices. Each National Competent Authority generates a National Competent Authority Report (NCAR) to alert other EU Competent Authorities whenever a Field Safety Corrective Action (FSCA) is undertaken by a manufacturer, which affects other EU countries. The National Competent Authority may also issue a NCAR to inform other Competent Authorities of a safe…
answer given date: 2012-03-26+01:00
answer has answering body: qjSEa2Ms
written answer has answering body: qjSEa2Ms