Pharmaceutical industry: Safety and pharmacovigilance

Computer screenThis page provides links to information about safety and pharmacovigilance, including adverse drug reaction reporting, periodic safety update reports, 'Drug Safety Update', as well as the associated legislation and guidance.

 

Reporting suspected adverse drug reactions (ADRs)

Important information on changes to the submission of Individual Case Safety Reports (ICSRs) for adverse drug reactions

E2B reporting

Anonymised single patient reports

Adverse drug reaction (ADR) reports received by the MHRA from literature articles

Best Practice in Reporting of Individual Case Safety Reports (ICSRs) PDF (685Kb)

 

 

Legislation and guidance

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Periodic safety update reports

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Good Pharmacovigilance Practice

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Drug Safety Update

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Defective medicines

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Letters sent to healthcare professionals

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Drug Analysis Prints (DAPs)

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Enquiries about pharmacovigilance

phone iconPharmacovigilance Service Desk
MA holders A-L: 020 3080 6550
MA holders M-S: 020 3080 6153
MA holders T-Z: 020 3080 7730
pharmacovigilanceservice@mhra.gsi.gov.uk

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Page last modified: 17 February 2011