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www.fdanews.com/articles/61256-uk-to-change-drug-manufacturers-license-format

UK TO CHANGE DRUG MANUFACTURERS' LICENSE FORMAT

July 28, 2006

Starting in August, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) will be changing the style of licenses issued for manufacturers and wholesale dealers, and some current license holders will also be required to hold a different type of license. The new format will also be common across the European Union.

The major noticeable difference will be for holders of manufacturer's licenses and wholesale dealer's licences, in that the MHRA will begin issuing licences in the style of the Manufacturer's/Importer's Authorisation. This is the format for manufacturer's authorization as defined by the European Medicines Agency (EMEA).

For some license holders, the licenses they currently hold will no longer be the correct. In these circumstances it will be necessary for them to be issued with a new license.