When new information about the benefits and risks of a pharmaceutical product become available it is often necessary to make changes to the safety information for the product.
From GVP to GMP
Starting in the Good Pharmacovigilance Practice (GVP) area, the corresponding variations have to be submitted by regulatory affairs staff, who will receive notification of variation approval. Then, Good Manufacturing Practice (GMP) applies, with arrangements for printing the updated leaflets and incorporating these into the supply chain.
According to the MHRA, updates to patient information leaflets should be introduced within 3 to 6 months of approval, or 3 to 6 months of the submission of the variation, in case the safety variation is submitted as a Type IAIN variation. Marketing authorization holders (MAHs) have to ensure that their products are manufactured and packaged in accordance with the current MA. In the case of a revision to the leaflet
- there should be a robust system that tracks the variation submission, the approval dates and the appropriate post-approval implementation date.
- the certifying QP must have visibility of license variations and approvals, so that they are fully aware of the current approved packaging, and the deadlines for introduction of updates to patient information leaflets.
- the QP should only be certifying batches containing the revised leaflet (i.e. by the end of the implementation period). Batches containing the “old” leaflet should not be certified by the QP as they are no longer in compliance with the terms of the MA.
MHRA´s tips for staying compliant
During recent inspections the agency has seen process gaps that can lead to non-compliance. Therefore, the MHRA provided three top tips to help ensure that updated safety information is implemented on time:
- Check that the end to end process facilitates the timely implementation of updates and that there is seamless transition from written procedures covering GVP, regulatory affairs and GMP.
- Define what is meant by ‘implementation’ of an updated leaflet and make sure this is in advance of regulatory deadlines to prevent the need for batches being re-worked.
- Ensure the QP has access to up to date information on the correct leaflet version that should be used at batch certification.
More information can be found in the post, “Passing the baton from GVP to GMP: Three top tips for protecting patients and staying compliant” on the MHRA Inspectorate blog.