Packaging and labelling
As we move through this year, the question of packaging and labelling will assume an even higher profile than it normally does within the pharmaceutical sector, with several concurrent challenges facing the industry.
As we move through this year, the question of packaging and labelling will assume an even higher profile than it normally does within the pharmaceutical sector, with several concurrent challenges facing the industry.
On the child resistance side, companies in the UK are working towards meeting their obligations under the UK Child Safety Regulations in relation to aspirin, paracetamol and iron products. These requirements will become fully operative in October 2005, with the consequential work that that requires in terms of packaging material changes and variations.
More recently, the amending Directive to the medicines Directive 2001/83 was adopted and requires that the name of the product must appear in Braille on the packaging of medicinal products by October 30 of next year. The practical application of this provision obviously poses a number of questions that will have to be resolved over the next 18 months.
The provision also requires that in certain cases the patient information leaflet be available in a format suitable for the blind and partially sighted (although, it would seem, not necessarily Braille). Again, it is essential that there is early guidance on fulfilling these requirements.
Over and above these topics there are moves in Italy, Belgium and Portugal to introduce 'vignette' systems to help with reimbursement matters. The manufacturing and quality implications of these schemes are significant and complex.
Trying to accommodate all these requirements poses challenges for regulators and regulated alike, and the pace of activity in this area will increase during this year as manufacturers seek to comply.
No doubt we will return to these issues in this column as the year progresses.