When new information regarding the risks and benefits of a product is established after a Pharmacovigilance investigation, it is prudent that changes are made to the safety information of that product. Patient Information Leaflets must be updated for Health Care Professionals and patients in order to use or prescribe the product safely.
Once the Pharmacovigilance team have issued new information and safety measures are identified, the regulatory affairs team will submit relevant variations to the MHRA for approval. The Patient Information Leaflets and Packaging must then be updated within 3-6 months of approval unless it is a type IAIN variation in which case the packaging and leaflets can be updated within 3-6 months of submission of the variation and you do not need to wait for the approval.
MA holders will always hold the responsibility to ensure the product is manufactured with the correct packaging advice and QPs must not certify any batch after the 6 months from approval, as they will no longer follow compliance with the MA. Vigorous procedures must be in place to track the progress of the variations and approvals to ensure they do not exceed the 6 months after approval.
So how do MA holders mitigate risk?
During recent MHRA inspections they have found process gaps leading to non-compliance and have issued the following 3 tips;
- Check that the end to end process facilitates the timely implementation of updates and that there is a seamless transition from written procedures covering GPvP, regulatory affairs and GMP processes.
- Define what is meant by ‘implementation’ of an updated leaflet and make sure this is in advance of regulatory deadlines and also includes checks that the correct versions of the leaflets are filed with the BOM to be submitted to the CMO to prevent the need for batches being re-worked should there be any unexpected delays.
- Ensure the QP has access to up to date information on the correct leaflet version that should be used at batch certification.