The Pharmaceutical Journal
Vol 278 No 7439 p181
17 February 2007

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Generics manufacturers collaborate on PILs

A scheme to ensure that patients receive similar patient information leaflets (PILs) from all manufacturers of the same generic medicine has been launched by the British Generics Manufacturers Association. As well as increasing the uniformity of information provided, the scheme will also reduce the regulatory burden on the generics industry and the Medicines and Healthcare products Regulatory Agency.

Participating companies will be given access to a library of user-tested PILs that they may then submit to the MHRA as part of their own new product applications or for existing licences. Participants will also be able to undertake “bridging” — using information from an approved PIL and applying it to closely related products.

June Raine, director of post licensing at the MHRA, said: “We welcome this innovative initiative from the generics manufacturers. Patients need consistent and high quality information about their medicines. This scheme will help to make a real difference to the many patients who rely on BGMA member companies for their medicines.”