Ensuring promotional
materials’ compliance
in the EU
By Monika Staniulyte, Regulatory Affairs Team Lead, Insuvia. A summary of a webinar originally presented on 15 February, 2023
2023-05-18T12:55:00
Directive 2001/83/EC is the EU legislation specifically covering promotional materials for the pharmaceutical industry – notably, Title VIII Advertising and Title VIIIa Information and Advertising. This is in addition to general consumer protection laws and unfair commercial practices regulations and directives. While Directives are legally binding and directly applicable to all companies. Some granularities can be introduced when it is transposed into national legislation by Member States (MS) individual legislatures.