17/18 November 2020
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.
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
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:
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.