February and March 2018 brought updates to the four EMA QRD Annex IV templates:

  • Conditional positive template
  • Exceptional circumstances positive template
  • Standard positive template
  • PSUR template

Please ensure that the most recent template is used when performing Linguistic Review.

See the EMA webpage for the latest versions: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59

What EUDRAC can do to help?

EUDRAC has well-established systems for the Linguistic Review procedure and has now conducted over 130 Linguistic Reviews for all types of regulatory procedures. Our labelling group work with our European Partners and translation teams, who are experienced and trained in the QRD template requirements including all standard terms, statements and formatting conventions.

For more information on Linguistic Review services, please contact us here.