Regulatory information – Updates to product information templates for all medicines for human use

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10/06/2015

Regulatory information – Updates to product information templates for all medicines for human use

Changes will enhance presentation of information for patients and healthcare professionals

The European Medicines Agency (EMA) has introduced a number of changes to the templates of the product information that accompany all medicines authorised for use in the European Union (EU). These changes are expected to improve the way information is presented on medicines.

The product information is part of the marketing authorisation of all medicines. It provides objective and up-to-date information about the quality, safety and efficacy of the medicine. The product information consists of the package leaflet with information for patients and the summary of product characteristics (SmPC) that is intended to guide doctors, pharmacists and other healthcare professionals in prescribing, dispensing and administering medicines. It also includes the labelling, information to be included on the outer packaging of medicines or on the immediate packaging.

The changes to product information templates are detailed in the updated guidance for the pharmaceutical industry published today. The main modifications are:

  • the printed package leaflet for patients may only contain the address of the local representative of the marketing-authorisation holder in the Member State where this particular medicine is sold, instead of the contact details of all local representatives in all EU Member States;
  • all strengths of the same pharmaceutical form of a medicine can now be combined in one SmPC, whereas until now a separate SmPC was required for each strength of the same pharmaceutical form.

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