PJ Online | News: Move to phase out BANs at end of 2003
The Pharmaceutical Journal
Move to phase out BANs at end of 2003
The Medicines Control Agency is proposing to phase out the use of British Approved Names (BANs) in favour of recommended International Non-proprietary Names (rINNs) starting in December 2003. The only exception would be the continued use of "adrenaline" and "noradrenaline", the most commonly used BANs.
In a consultation letter issued on 4 September, the MCA says that although European law requires the use of rINNs, this has not been strictly applied in the United Kingdom because of the well-established use of BANs and public health concerns about the potential for medication errors if the names of certain critical substances were changed. A previous MCA proposal to switch from BANs to rINNs was withdrawn for legal reasons.
However, the MCA says that there is now a need to clarify the position as other European Union member states routinely use rINNs. Such products can appear in the UK under rules covering mutual recognition of product licences within Europe. In addition, pharmaceutical companies can use rINNs in applications for marketing in the UK. "The confused situation is itself a possible contributory factor to medication errors," the MCA says.
Following consultations with the Medicines Commission and health departments in England, Scotland and Wales, the MCA is now proposing to start phasing out the use of BANs from December 2003. Companies will have 12 months to change their product licences, for which the MCA will charge a fee, or 24 months if the BAN is only used in the summary of product characteristics or patient information leaflet. The MCA believes that such changes will take place alongside routine updates.
For adrenaline and noradrenaline, the MCA will demand that companies currently using rINNs (epinephrine and norepinephrine) change to using BANs for consistency. No fee will be charged for this.
The MCA is seeking comments from interested parties by 18 September ahead of a wider public consultation exercise. Comments can be sent to Chris Bantock, European Support Unit Manager, Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ (tel 020 7273 0395, e-mail email@example.com).
Citation: The Pharmaceutical Journal URI: 20007692
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