As the dust settles on Brexit, it is interesting to consider the impact on the user testing of Patient Information Leaflets (PILs), which was originally a requirement under European law, Article 59(3) of Directive 2001/83/EC as amended by Directive 2004/27/EC.
PIL regulation is now governed by UK law, with guidance on the production of PILs set out in Part 13 of the Human Medicines Regulations 2012, In essence, nothing has changed as PILs still require an assessment of the “package leaflet carried out in co-operation with target patient groups.”
Throughout the Covid Pandemic Cognisant Research has continued to carryout PIL user tests, using a combination of video conferencing and face to face assessments. This has enabled us to comply social distancing rules whilst at the same time allowing our many client to maintain as far as possible business as usual.
For details of our PIL test services contact Ian Nockolds on 01761 408165.