RMP for significant SPC updates

Dear PIPA,

Could you please provide some guidance regarding submitting Risk Management Plan for a product that requires significant updates to its SPC?

A product SPC and PIL will be updated which will result in addition of information on to undesirable effects and contraindication. Would this update to SPC and PIL require resubmission of RMP?

Thanks.

Dear Member

Thank you for your query.

Please note that the response to your query represents the opinions formed from a consensus of the PIPA committee, but does not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company’s procedures.

Where information held by the MAH leads to updated information about the safety profile of a product and where the updated information is called out specifically within the product’s RMP; then the RMP and any associated additional risk minimisation materials (aRMMs) will need to be reviewed and assessment made. If the assessment shows that the benefit risk profile has altered that the RMP and aRMMs will need to be updated.

Updates to the RMP are required where there is a change to the safety information that impacts or alters an important risk (as defined in the EU and UK GVPs) these can be added or removed or the aRMMs modified. Updated versions of these documents will need to be submitted and approved by relevant Competent Authorities.

We do hope that the above answers your query.

PIPA

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