Consultation outcome

MHRA business engagement assessment - variations processing review

This consultation has concluded

Download the full outcome

Detail of outcome

MHRA sought views on a new process to coordinate assessment and processing of applications to change (vary) a medicines marketing authorisation called Composite Coordination Collection (CCC).

The agency asked the pharmaceutical industry to comment on any aspect of the business engagement assessment, particularly with a view to quantify costs and benefits of the proposal.

Original consultation

This consultation ran from to

Summary

MHRA has published a business engagement assessment on Composite Coordination Collection (CCC).

Documents

Consultation description

MHRA is seeking views on a new process to coordinate assessment and processing of applications to change (vary) a medicines marketing authorisation called Composite Coordination Collection (CCC).

The agency would like the pharmaceutical industry to comment on any aspect of this business engagement assessment, particularly with a view to quantify costs and benefits of the proposal.

The deadline for comments is 30 January 2014 and a final business engagement assessment will be published shortly after.

Please send comments to stephen.fawbert@mhra.gsi.gov.uk.