Changes to Patient Information Leaflets and Labelling. Under Article 61(3) of Council Directive 2001/83/EC, MA holders must inform the competent authority of all changes to labelling and patient information leaflets which are not connected with changes to the Summary of Product Characteristics (SPC).
In the UK, MA holders can currently choose whether to self-certify changes to leaflets and labelling via the Notification scheme, or to send the change to the MHRA for assessment via an Article 61(3) application.
From 1st July 2012, in the UK, ALL changes must be self-certified UNLESS they fall into one of 4 specific categories. Only changes which come under these categories will be assessed by the MHRA Patient Information Quality Unit (PIQU).
With self-certified changes via the Notification scheme, the MA holder notifies the MHRA of the details of the amendments and makes a declaration to confirm that the legislative requirements have been met. Self-certified changes will be acknowledged and accepted by the MHRA within 14 days of submission, and the changes can be implemented on receipt of the MHRA’s acceptance letter.
Changes which fall into the 4 specific ‘application for assessment’ categories, termed P1, P2, P3 and P4, will require submission of an Article 61(3) application. These changes will be assessed within 90 days of validation.
If you have any queries about how to update leaflets and labelling, or would like guidance on what documentation is required, please contact us.