The Pharmaceutical Journal
Vol 271 No 7269 p438
4 October 2003

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Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk)

MHRA overwhelmed by new applications

Applications for new product marketing authorisations have swamped the Medicines and Healthcare products Regulatory Agency, which has warned companies that licences are likely to be delayed.

The cause of the problem is a European Union requirement that applications should be made in a new format called the common technical document. The European implementation date was 1 July, with national implementation from 1 October.

The MHRA received three times the normal number of applications in June and does not expect processing times to return to normal until the end of December. It has warned companies that if there is a further surge in applications attempting to beat the 1 October deadline, the situation will be worse and licences are unlikely to be issued normally until into 2004.

Applications for variation to marketing authorisations have been similarly affected, with the equivalent of three months’ worth of applications having been received in June and July.