The End of the Printed Package leaflet?

Pharmaceutical Industry Associations (AESGP, EFPIA, and Medicines for Europe) have jointly published recommendations regarding the implementation of the electronic Product Information (ePI) and improvement of the patient leaflet content. Previously, a pilot report on ePI was released.

Key Recommendations

Key recommendations include the following topics:

• ePI phasing-in, paper phasing-out: The gradual phasing in of ePI is proposed to be fully operational within 4 years of the entry into force of the revised General Pharma Legislation and will precede the phasing out of printed package leaflets. This will ensure that patients have continuous access to important information on medicines through secure, harmonized digital platforms. Existing ePI platforms such as national competent authority and industry websites and compendia could be used as solutions to initiate the transition before ePI becomes fully available on the EMA/HMA portal. Phasing out paper in self-administered products will be more gradual than for HCP (healthcare professionals)-administered products due to individual needs, administrative capabilities and product specific requirements.
• Improve the PIL: Patient information leaflets would benefit greatly from improvements in layout and readability. There are a number of proposals to promote the correct and safe use of medicines by providing clear information to improve health literacy.
• Patient safety and digital access: With 90% of EU citizens having regular access to the internet, ePI will enable the availability of up-to-date leaflets, interactive elements, personalized content, and more accessible formats such as large print or multimedia. However, alternatives for those without internet access will be be maintained to ensure inclusivity.
• Ensuring availability in small markets: Multi-country packaging, simplified by the use of ePI, language waivers and harmonized labelling requirements, will improve the availability of medicines across Europe, particularly in smaller markets, reducing logistical burdens and promoting greater supply chain agility.
• Improving regulatory processes: The ePI platform is designed to streamline regulatory processes and reduce administrative burdens for both pharmaceutical companies and regulators. Moreover, EMA's centralized portal will serve as a single source of trusted information, promoting transparency and regulatory efficiency across the EU.

For more information please see Industry Proposes Phased Rollout of ePI for Patient Safety and Environmental Sustainability.