Reporting suspected defects in medicines

The DMRC provides an assessment and communication system between suppliers (manufacturers and distributors), users of medicines and other regulatory authorities. 
  
Manufacturers and importers are obliged to report to the MHRA any quality defect in a medicinal product which could result in a recall or restriction on supply. Other users and distributors of medicinal products are encouraged to do this.

Where a defect is considered to be a risk to public health, the marketing authorisation holder withdraws the affected product from use and the MHRA issues a 'drug alert' letter. This alert is classified from 1 to 4 depending upon the risk presented to the public health by the defective product. Class 1 is the most critical, for example serious mislabelling, microbial contamination or incorrect ingredients, and requires immediate recall; Class 4 is the least critical and advises 'caution in use'.

The DMRC is also part of the European Rapid Alert System which disseminates information on drug quality issues within EU Member States.

Patients or members of the public who have concerns about the quality of a medicine should in the first instance refer the matter to their pharmacist or doctor, who may then decide to contact the MHRA. During business hours this is the preferred option as an actual sample can be examined straightaway, whereas sending samples to the MHRA normally takes 1 - 2 days. Should this not be possible, patients and members of the public may contact the DMRC directly.

Suspected defects can be reported by telephone, fax, e-mail or letter or using our online form.

Telephone: 020 7084 2574 (during office hours Monday to Friday 0900 -1700, 020 7210 3000 (urgent calls outside of normal working hours, at weekends or on public holidays).

Fax: 020 7084 2676

E-mail: info@mhra.gsi.gov.uk

Online form: Suspected defect reporting form