The EU Directorate-General for Health and Food Safety released a new "Proposal for Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency" envisages the use of the electronic product information (as opposed to paper leaflets) to achieve administrative cost reductions.
The full version of the proposal (which goes by the full name of: Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006), released on the 26 April 2023, is available at here
In the proposal there are several references to the use of digital means to accelerate and improve the availability of medicinal products within the EU market, among the foreseen improvements are:
- electronic submissions by industry to the European Medicines Agency and competent authorities of the Member States will deliver cost savings to industry
- use of the electronic product information (as opposed to paper leaflets) should also lead to administrative cost reductions
- in order to harmonise the performance of the pharmacovigilance activities....implement measures covering ... the format and content of electronic transmission of suspected adverse reactions by Member States and marketing authorisation holders.
Take away message: the EU is working on new legislation to harmonize the approval, distribution and monitoring of medicinal products within the EU and the implementation and regulation of digital solutions is an integral part of this new proposal.
The eLeaflet solution from myHealthbox is already supporting most of the ePI requirements including the collection and management of digital Adverse Reactions Form, to know more about this solution a good starting point is the eLeaflet home page.
For any questions, contact our Customer Service at info@myhealthbox.eu