European Medicines Agency Publishes Action Plan to Improve Medicine Package Leaflets
- 16/11/2017
- Articles
On 14 November 2017, building on an assessment report which the European Commission (the “Commission”) prepared in March 2017, the European Medicines Agency (“EMA”) presented an action plan to improve EU product information for medicines (the “Action Plan”).
The Action Plan focuses on the package leaflet (“PL”) rather than the Summary of Product Characteristics (“SmPC”) in line with the Commission’s findings that there is most scope for progress with regard to the information supplied to patients. As a result, the Action Plan lists the following steps:
- Revision of existing PL guidelines, including the Readability Guideline and the Packaging Information Guideline, as well as, if necessary, the SmPC Guideline (to ensure alignment with the PL);
- Revision of the template for the quality review of documents;
- Production of guidance on translations;
- Improvement of patient input in developing and testing PLs;
- Creation of an online platform for the promotion and exchange of best practices (involving regulators and industry);
- Exploring use of electronic formats for both SmPCs and PLs;
- Considering creation of “key information” section in both SmPC and PL.
