Artwork and labelling play an important role in the marketing process of any drug product. Advertising and labelling text(s) for prescription and OTC drugs are highly regulated.
Directive 2001/83/EC requires that label text must be in accordance with the approved Summary of Product Characteristics (SmPC). For centrally registered products there is only one SmPC, for Mutual Recognition or Decentralised Procedures the SmPCs are harmonised for the countries where the product is registered. In these cases the label texts are also harmonised in the countries where the product is launched. For “older” national licences with possibly different SmPC the label texts and Patient information Leaflet may differ from country to country.
PIM (Product Information Management) is a system introduced by the EMEA (European Medicince Agency) in the first instance in December 2005. It has been conceived as a means of:
Document management software + Change Control processes
PIL(s) and label texts are part of the drug product which come into direct contact with the consumers. It must be stressed that non-compliant artworks and labels can be the cause of serious compliance issues which in the worst case can lead to batch and/or product recalls which could cost companies millons.