New Pharmacovigilance Directive

The new Pharmacovigilance Directive [Council Directive 2010/84/EC] requires the European Commission (EC) to produce a report on the shortcomings of product information and to bring forward proposals for legislative change.

The EC has engaged consultants to produce this report and publication is expected in the summer of 2013.

A preliminary review by the MHRA proposes changes in the legislation to achieve improvements in the information provided both to healthcare professionals and patients.

In particular they suggest legislation should include the following;

  • enable personalised information, allowing for information hierarchy, in order that users can drill down into detail as it applies to them
  • require the provision of information via new media, to ensure timely access at different points in the user journey
  • require a balance of information in the leaflet so the likelihood of benefit is put in the context of the likelihood of harm, and
  • mandate signposting to other sources of information helpful to users.

Regulis will continue to monitor the situation and keep clients advised of the situation as further details emerge.

Regulis offers a full service with respect to leaflets and user testing, including initial drafting, readability testing and preparation of bridging reports.