Regulatory Focus™ > News Articles > MHRA Announces 'Procedural Changes' for Submission of Labels, Patient Leaflets

MHRA Announces 'Procedural Changes' for Submission of Labels, Patient Leaflets

Posted 02 April 2012 | By Alexander Gaffney, RAC 

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced last week (29 March) it would be making "procedural changes" to the process by which sponsors of marketing authorization applications (MAAs) submit full-color mock-ups of labels and patient leaflets.

In its new guidance, Labels & Patient Leaflets in the Initial & Final Submission Documents for New MA and Type 1B or Type II Variation Applications, MHRA notes several changes, including:

  • the guidance only applies to mutual recognition, decentralized and UK-only procedures
  • full-color labels and patient leaflets should be submitted with the Day 0 submission to MHRA
  • if authorization is granted without full-color mock-ups being submitted, the product may not be marketed until the label and leaflet are approved in full-color form


Read more:

Labels & Patient Leaflets in the Initial & Final Submission Documents for New MA and Type 1B or Type II Variation Applications - New MHRA Guidance as from 1 April 2012

MHRA introduces more flexibility for the submission format of labels and patient leaflets


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