MHRA is making more widely available a new scheme for coordinating the submission and assessment of variations and changes to the packaging/patient information leaflet that are submitted in parallel to amend a marketing authorisation. The scheme is called Composite Co-ordinated Collections (CCC) and is being piloted from October 2014.
The benefits of the CCC scheme for multiple parallel procedures are that:
- processing and assessment of applications will be coordinated and more streamlined
- only one consolidated mock-up needs to be submitted
- the normal rules of grouping and bulking of variations apply
- the scheme costs no more than current submissions
This diagram sets out how the CCC scheme works:
Each CCC application can be made up of a mixture of variations (comprising single or grouped changes) and Article 61(3) applications to amend labels and patient information leaflets. The CCC can be applied to one or more product licences. All the applications are ring-fenced, effectively providing a one-stop-shop for updating for updating product information (SmPC, PIL and labelling).
The CCC scheme excludes purely Type IA notification and notifications of changes to packaging, patient information leaflet and labelling under the self-certification scheme. Urgent or significant variations that impact on the safety of a product should not be submitted through the CCC scheme, as it may delay implementation of the changes.
If you want to make a CCC submission use our guidance document (714Kb) which sets out the content of a CCC application and how to make your submission.
If you have a question about this guidance email email@example.com including CCC in the title of the email.
The MHRA is also hosting half-day seminars on the CCC scheme, variations grouping and PIQU submission on 05 and 06 February 2015. View the programme and register your interest.