Patient information
EU Directive 2004/27 introduced major new requirements in respect to patient information leaflets (PILs) provided with medicines. Marketing authorisation applicants / holders must ensure that PILs reflect the results of testing with potential users, including patients It is then required for MHRA to assess the PIL plus user test.
To improve consistent information to patients and significantly reduce the prohibitive cost of each company user testing every single PIL (at a cost per test in the region of £10,000), the BGMA decided that co-ordination of user testing of PILs could be of significant benefit to patients, industry, MHRA and the NHS. An innovative implementation plan was agreed with MHRA.
Through work sharing, BGMA has delivered leadership in improving information to patients about their medicines.
BGMA members also have a strong commitment to ensuring their packaging meets patient needs and compliance and have been congratulated by the NPSA on leading improvements in this area.
