Includes guidance for pharmaceutical companies on discontinuing medicines, including who should be notified and consulted and the best practice to follow when a medicine is in short supply.
Guidance on discontinuing a medicine, including who should be consulted and who should be notified at each stage of the process.
Includes guidance for ABPI and BGMA members to help minimize the impact of a shortage of a medicine, including proformas for companies to use to notify the Department of Health about an impending shortage.
These guidelines complement the statutory requirements to inform the Licensing Authority (the MHRA in the UK) of any disruptions to supply (the so-called 'sunset clause') under new European medicines legislation (Directive 2001/83/EC as amended). Information on complying with the relevant provisions can be found on the MHRA’s website at: