Tag Archives: PIL

MHRA publishes timeframes for publication & distribution of updated SPCs and PILs

The MHRA has published an update to the Good Pharmacovigilance Practice section of their website.  The update concerns the publication and distribution of updated Summaries of product Characteristics (SPCs) and Patient Information Leaflets (PILs) following safety-related changes.  The MHRA recommends specific timeframes for completing activities relating to updated SPCs and PILs, following findings by the GPvP Inspectorate.

It is important for Marketing Authorisation Holders to note the expectations of the MHRA relating to timeframes for publication and distribution of these documents, to ensure timely risk communication to internal and external customers.

More information on the guidance published by the MHRA can be found by following the link below: