Ensuring correct version of SPC/PL retrieved
Generally variations to SPCs involving amendments to leaflets must have the new SPC and leaflet implemented by industry within 3-6 months of the MHRA approval date.
However a patient taking a medicinal product who wishes to find a leaflet may therefore look up what is currently approved on the MHRA site, but which may not be the correct leaflet for the product they are currently taking. A simple example is colour change where old tablets blue and new tablets pink.
In addition many medicinal products have long shelf lives e.g. 5years, hence 'old' leaflets relevant to blue product may exist in the market place alongside the later product containing the new leaflets for the pink product.
Therefore how will the MHRA ensure this information is conveyed to Patients and HC professionals and not cause confusion or unnecessary worry?
In my exprience the MAH is the most suitable information source to explain these issues to patients and HC professionals. Although in principal agree that MHRA could be the source of this information it should be made clear to instruct those downloading such information to contact the MAH or provide access to previous leaflets/SPCs with a record of each variation change and sections of SPC/PL affected.