Changes to labelling and patient information leaflets for all medicines subject to self certification by the applicant and formal notification to the MHRA

Background
Following the work of the Better Regulation of Over-the-Counter Medicines Initiative (BROMI), the Patient Information Quality Unit (PIQU) is extending the notification scheme for certain defined changes to labelling and patient information leaflets (PIL) to all medicines regardless of legal category. The categories of changes which are deemed suitable for self certification along with conditions which apply are set out in the MHRA guidance on changes to labelling and patient information leaflets for self certification document (75Kb). This notification procedure provides for a rapid and efficient processing of certain defined changes submitted to the competent authority under article 61(3) of Council Directive 2001/83/EC. The notification scheme applies only to those defined changes in relation to the packaging components for all medicines with the exception of parallel imported products.

How to make a notification
Where the proposed changes to the packaging fall within the categories described and you are able to meet the prescribed conditions you may apply via the notification scheme to register the changes on your marketing authorisation.  The notification form for submission electronically can be found below.   Companies with access to the portal should use the General Product Licence Submission form available at the portal.  You will however need to copy over the declaration statement and the definition of the changes applied for in order for the notification to be deemed valid and processed correctly.  

Notifications made to the MHRA under these provisions will be acknowledged within 14 days of receipt and can then be introduced immediately.   For the moment normal fees in respect of changes to labelling and patient information will apply.  Where relevant you may apply for a reduced fee in the case of bulk applications submitted concurrently.

• Notification form (128Kb)

Applicants intending to self certify the changes submitted must state clearly on the notification form that it is submitted under article 61(3), which change number(s) is/are relevant and that the necessary conditions have been complied with.  The following form of words should appear in section 3 of the form:

“This notification is submitted under article 61(3) of Council Directive 2001/83/EC.  Changes notified fall into the following category:
[insert change number(s) and description(s) from MHRA guidance document].
I confirm that the prescribed conditions associated with the change have been met and that no other changes have been introduced.”

• Make sure that you reference the change number which applies along with the details of what is being changed on the respective packaging components.
• More than one change from the published categories may be applied for at any one time but you must ensure that all changes implemented are covered by the published guidance and referenced correctly on the notification form appropriately.
• Any changes introduced to the packaging components but not formally notified, or not covered by the published guidance, may render the notification invalid.
• Full colour mock-ups of the proposed final version of the packaging components affected by the change must accompany the notification.

Changes not covered by the guidance or where the prescribed conditions have not been met cannot be considered for self certification and must be the subject of a formal application to the Patient Information Quality Unit.   Normal timescales for assessment will apply and in these circumstances changes should not be implemented in the absence of a formal approval letter. Please send electronic notifications for the attention of Area 6, as set out in Special Mail 5 (367Kb).  Paper notifications should continue to be sent to the addresses provided in Special Mail 3 (89Kb).

Monitoring
Acceptance of these notifications is based on declarations by the MAH that the prescribed conditions have been fulfilled and the necessary supporting documentation has been submitted.  MHRA will be operating a quality audit system based on both random and targeted sampling of notifications submitted to monitor the validity of the submissions.  Outcome reports from these audits will be published on our website quarterly.   Details of the audit process are available below:
› Changes to self certification - quality audit (51Kb)

Quality audit reports
The quality audit reports are available below:
› Quality Audit of Notifications in Respect of Changes to Labelling and Patient Information Leaflets Submitted Under the Better Regulation Of Medicines Initiative (March 2007 - May 2007) (26Kb)
› Quality Audit of Notifications in Respect of Changes to Labelling and Patient Information Leaflets Submitted Under the Better Regulation Of Medicines Initiative (December 2006 - February 2007) (23Kb)
› Quality Audit of Notifications in Respect of Changes to Labelling and Patient Information Leaflets Submitted Under the Better Regulation of Over-the-counter Medicines Initiative (May - November 2006) (22Kb)

Contact for further information
Further information is available from The Patient Information Quality Unit, MHRA, 14-1, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ or e-mail patient.information@mhra.gsi.gov.uk.