Artwork and labelling
Artwork and labelling play an important role in the marketing process of any pharmaceutical. The advertising and labelling texts for prescription and OTC drugs are highly regulated.
QbD’s regulatory experts will help you to create artwork and labelling for your products in full compliance with current regulations.
Marketing in compliance
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 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
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
How we support you
- Prepare compliant PILs and labels texts based on SmPCs
- Oversee texts translation projects
- Check PILs and Labels texts for compliance
- Advise on user testing for PILs
Why opt for the QbD Group?
EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS
10+ years of experience
Benefit from our team of highly qualified consultants.
Full life cycle support
Full support from pre- to the post-marketing phase.
Global presence
QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.
Customer satisfaction
Constant evaluation, transparency and clear objectives.
Contact us
Talk to an expert
Contact us for more information or to request a free, no-obligation proposal.