MCA Advice On Varying MAs In UK

Britain's Medicines Control Agency has begun assessment of Phase VI of the Patient Pack Initiative, and says it is continuing to get an excellent response from marketing authorization (MA) holders.

However, it notes that recent submissions for patient information leaflets have highlighted a problem regarding the content of Summary of Product Characteristics. PILs have often been drafted to reflect the current clinical situation, it says, without applying for the necessary variation(s) of the SPC in advance of the submission.

It is important for applicants to remember, the MCA stresses, that the leaflet is legally required to be consistent with the MA, and that the MA must be varied before the leaflet can be approved.