Updated Product Information templates
Πέμπτη 11 Ιούν 2015
Regulatory Watch

The EMA has informed that a number of changes have been made to the templates of the product information (Quality Review of Documents (QRD) templates) that accompany all medicines authorised for use in the European Union.

The changes to product information templates are detailed in the updated guidance (QRD templates version 9.1). 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.

An implementation plan for the revised QRD templates as well as a policy document on combined Summaries of Products Characteristics (SmPCs) have also been published. The revised QRD template is also available in track-changes

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