The Pharmaceutical Journal
Vol 268 No 7180 p3-8
5/12 January 2002

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Medicines Control Agency proposes to simplify and accelerate the medicines reclassification process

Proposals for a new process to change the legal status of medicines have been put forward by the Medicines Control Agency. Under the new system, which is expected to come into effect in April, medicines will no longer be classified as POM, P or GSL according to where their active ingredients are listed in the POM Order or GSL Order. Instead, they will be classified through statements in the marketing authorisations of individual products.

The MCA says that the change is needed because the number of applications to switch ingredients from POM to P status is falling. It believes that the change will make switching products from one classification to another simpler and quicker.

Under the new system, only licence holders will be able to seek the reclassification of medicines and those who do so first will have an effective monopoly over reclassified sales for about three months before other manufacturers whose products include the same active ingredients can follow suit and apply for a status change. Only applications that include full supporting data will be accepted and all other applications will be deemed invalid unless they include their own supporting data. Second, and later, applicants will only be permitted to rely on data provided by previous applicants once full approval of the preceding application has been granted, giving first applicants a 90-day competitive advantage.

Changes will no longer require amendments to be made to the POM Order, and Schedule 1 of the order will only list ingredients that are not in any licensed products.

The new system will bring the United Kingdom into line with systems operated in most other European Union countries. One effect will be that there will no longer be a fixed six-monthly timetable for changes to the legal classification of medicines. Applicants will not have to meet deadlines for changes to be made by a specified date and changes to status will take effect immediately an alteration is approved.

Public consultation on proposed changes will follow a rolling programme and will take place via the MCA website (www.mca.gov.uk) rather than by issuing MLX consultation letters. The maximum expected time for a change to legal status from application will be 120 days.

Comments on the proposal, contained in MLX279, can be sent to Tricia Griffiths, Medicines Control Agency, Room 14-110 Market Towers, 1 Nine Elms Lane, London SW8 5NQ until 8 February.

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