Defective medicines

The Defective Medicines Report Centre (DMRC) receives and assesses complaints and reports of actual or suspected defects in medicinal products for human use and co-ordinates the necessary actions.

Woman looking at medicine bottles

 

New contact numbers for the DMRC

The DMRC moved to Buckingham Palace Road, in Victoria on 15 October 2010

The new telephone numbers are as follows:

 DMRC Hotline  020 3080 6574
 Mrs A Bunce (Pharmaceutical Assessor)  020 3080 6637
 Mrs C Cox (Administrator)  020 3080 6993
 Mr I Holloway (DMRC Manager)  020 3080 6608
 Mr U Ahmed (Administration Manager)  020 3080 6588

The Agency is operating a policy of ‘hotdesking’ at the new site. The DMRC will be located on the fifth Floor, 151 Buckingham Palace Road, London SW1W 9SZ. Staff email contacts will not change.

Find out more about the relocation of the MHRA head office

 

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. 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.


Reporting a suspected defect
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 one to two 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, email or letter or using our online form.

Telephone: 020 3080 6574 during office hours Monday to Friday 08:45 -16:45
020 7210 3000 for urgent calls outside of normal working hours, at weekends or on public holidays.

Email: info@mhra.gsi.gov.uk


Guide to defective medicinal products
We have produced a guide in response to the wide range of enquiries the DMRC receives on suspected defective medicinal products.

'A Guide to Defective Medicinal Products'

 


Page last modified: 07 February 2012