Regulatory Focus™ > News Articles > UK Recommends Amendments to EU Pharmacovigilance Directive

UK Recommends Amendments to EU Pharmacovigilance Directive

Posted 06 February 2013 | By Louise Zornoza 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has submitted recommendations to the European Commission to amend the recently implemented EU pharmacovigilance legislation. 

In a January 16 letter to the European Commission's Health and Consumers Director General, MHRA recommended changes to patient information that would:

  • Enable patients to get most important information first and then allow them to drill down into more detail as needed.
  • Require the provision of information via new media, to ensure timely access at different points in the need for information.
  • Require a balance of information in the leaflet so the likelihood of benefit is put in the context of the likelihood of harm.
  • Mandate signposting to other sources of information helpful to users. 

The recommendations are those of the MHRA's Expert Advisory Group on Patient and Public Engagement and the Commission on Human Medicines, which reviewed current patient information leaflets (PILS).  The recommendations are intended to assist the European Commission in the report that it is preparing on the shortcomings of product information that should be released in the summer of 2013.  


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