Guidance notes for patient safety and pharmacovigilance in patient support programmes

Guidance notes for patient safety and pharmacovigilance
Publication date:  06/05/2011
Publication ref: 
**This guideline is being revised in light of the new pharmacovigilance legislation. Please follow the requirements in EMA Good Pharmacovigilance Practices (GVP) and use the following address to submit any questions: QandA-PV-legislation@ema.europa.eu. If you have any questions on the ABPI pharmacovigilance guidance documents, please contact us on: abpiregulatory@abpi.org.uk **

Patient support programmes (PSP) are set up by companies to help patients and /or healthcare professionals better manage disease and optimise treatment. It is imperative that patient safety is a priority in PSPs and that the company is able to meet ethical, legal and regulatory obligations including pharmacovigilance (PV) requirements.  These notes are a compilation of best practice, based on current legislative requirements and PV inspection findings.  They have been developed by the ABPI and shared with the Medicines and Healthcare Products Regulatory Agency (MHRA). 


Document size: 204KB



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