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Ways to report suspected defects
Suspected quality defects can be reported via our Yellow Card reporting site
Other methods of reporting include:
Defective Medicines Report Centre
The Defective Medicines Report Centre (DMRC) is a unit of the Inspection, Enforcement & Standards Division of the MHRA.
The role of the DMRC is to minimise the hazard to patients arising from the distribution of defective medicines by providing an emergency assessment and communication system between manufacturers, distributors, regulatory authorities and users.
It achieves this aim by:
Recalls and drug alerts
Where a defective medicine is considered to present a risk to public health, the marketing authorisation holder, or the manufacturer as appropriate, is responsible for recalling the affected batch(es) or, in extreme cases, removing all batches of the product from the market.
The DMRC will normally support this action by the issue of a drug alert notification to healthcare professionals. Drug alerts are classed from 1 to 4 according to their criticality and the speed with which action must be taken to remove the defective medicine from the distribution chain and, where necessary, from the point of dispensing and use. This varies from immediate action for a Class 1 alert, to action within five days for a Class 3 alert. In some low-risk circumstances the product may be allowed to remain in the supply chain when the DMRC will issue a Class 4 “caution in use” alert. In the case of Class 1 and Class 2 drug alerts, the DMRC will notify regulators in other countries using the European Rapid Alert System.
Reporting suspected quality defects
Manufacturers, importers and distributors are obliged to inform the MHRA of any suspected quality defect in a medicinal product that could or would result in a recall, or restriction on supply.
Healthcare professionals also have a responsibility to inform the MHRA of any matter coming to their attention that might reasonably cause the Agency to conclude that it relates to a quality defect.
If a patient or member of the public has reason to believe that their medicine is not of an acceptable quality they should, in the first instance, consult with their doctor or a pharmacist who may then decide to refer the matter to the MHRA. A doctor or pharmacist can provide prompt advice and/or reassurance to the patient as well as differentiate between undesirable side effects and defective medicinal products. However, if it is not possible to speak to a doctor or pharmacist and the patient feels that the matter is urgent, they may contact the DMRC direct.
The MHRA Guide to Defective Medicinal Products (378Kb) sets out what should be done by members of the public, patient’s, healthcare professionals, manufacturers and distributors before any contact is made with the MHRA.
Further information and guidance is available in the MHRA Guide to Defective Medicinal Products (378Kb)
|Page last modified: 24 November 2014|