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ARMs: Applications to reclassify medicines consultation letters

A new process by which the legal status of medicines is awarded in the UK came into effect on 1 April 2002. Legal status (prescription only, pharmacy or general sale list) is now part of the marketing authorisation rather than determined by the active substance listed in secondary legislation.

This change enables applications to be dealt with faster by removing the need to amend statutory orders. In designing the new reclassification procedures, we took the opportunity to introduce changes to how we consult - some of which were set out in the consultation document MLX 279. Respondents to MLX 279 broadly welcomed the proposed changes to the consultation process. As each application will merit its own consultation, with a dedicated timetable, we will not be using the MLX prefix for reclassification consultations but rather a dedicated prefix - 'ARM' (application to reclassify a medicine).

Contact for further information
For further information on ARMs , please contact our Reclassification Unit, 14-1, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 2523, fax 020 7084 2293 or e-mail our Central Enquiry Point.

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Page last modified: 29 July 2008