Standard operating procedure - Europa

7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail Website European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. Standard operating procedure Title: Dealing with reports of suspected defective medicinal products Status: PUBLIC Document no.: SOP/INSP/2018 Lead author Approver Effective date: 08-OCT-12 Name: Brendan Cuddy Name: David Cockburn Review date: 08-OCT-15 Signature: On file Signature: On file Supersedes: SOP/INSP/2018 (01-APR-07) Date: 05-OCT-12 Date: 05-OCT-12 TrackWise record no.

(FDA Warning Letters, WHO notices of concerns, EDQM), or information received from “whistle-blowers”). It is also a basis for dealing with quality related crises which affect nationally authorised products and where a Member State has requested a central co-ordination of the issue, or where the issue has been referred to the CxMP.

Loading..

Tags:

  Operating, Standards, Procedures, Requested, Standard operating procedure

Information