It is evident that the labeling requirements in the European Union (EU) are quite dissimilar, given various region-specific regulations across the 27 member states. Besides this, the emerging European Regulatory landscape demands life sciences manufacturers to be more cautious in implementing and showcasing the safety information.
In the status-quo, to sail through the European market compliantly, organizations must be aware of:
- EU Member States’ Regional Labeling Requirements
- Clinical Labeling specifications for both IMPs and AMPs
- Quality Review of Documents (QRD)
- Product Information (PI) Templates
- Linguistic and Translation Barriers
- Transition Exemptions
Mere knowledge on the above-mentioned factors alone however won’t suffice the requirement of compliant market-entry. While adopting the regulations; how quick and streamlined are one’s labeling processes also stand crucial. Market-entrants should be able to track the label changes in real-time and implement the changes across the global and regional labels in parallel.
To attain such control, what kind of technological best practices they should adopt? Gain exclusive insights in our free webinar session on “Label the Labeling data to organize, regulate, simplify, and uncomplicate – EU perspective.” Join us on Mar 18, 2020, 2.00 PM GMT.