Artwork and labelling

Directive 2001/83/EC requires that label texts 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 harmonized for the countries where the product is registered. In these cases, the label texts are also harmonized 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

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:

• Increasing the efficiency of the management and exchange of product information (Summary of Product Characteristics, package leaflet and labelling) by all parties involved in the evaluation process through the structuring of the information and its exchange by electronic means; and improving the quality and consistency of the published product information
  PIM may be used either within, or outside, the eCTD
  Software Requirements
  Document management software + Change Control processes
• Appropriate archiving and electronic document management for packaging materials (repository)
  Revision numbers
  Change Control
  Process flow management
  Versioning
  SOPs
  provision of XML-based authoring tools