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Alert handling guideline
Version 5.0 – updated 16.5.2024
Table of contents

Verkkojulkaisun valikko EN

  • 1.-2. Purpose and scope
  • 3. Definitions
  • 4. Alerts returned by the Medicines Verification System
  • 5. Exceptions returned by the Medicines Verification System
  • 6. Processes for handling and investigating alerts
  • 6.1 Support and contact details
  • 6.2 Unknown serial number
  • 6.3 The serial number is unknown. The batch has not been found
  • 6.4 The batch identifier mismatches the recorded batch identifier
  • 6.5 The expiry date mismatches the recorded expiry date
  • 6.6 The pack cannot be supplied. OR The pack was previously supplied at this location
  • 6.7 The pack cannot be decommissioned. OR The pack is already decommissioned at this location
  • 6.8 The pack cannot be reactivated. Time limit exceeded.
  • 6.9 The pack cannot be reintroduced. It was supplied at another location. OR The pack cannot be reactivated. It was decommissioned at another location.
  • 7. Roles & Responsibilities
  • 8. Reference documents

8. Reference documents

Document Identification Title
Falsified Medicines Directive (2011/62/EU)

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011L006… (EN)
Commission Delegated Regulation (EU) 2016/161

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02016R016… (EN)
Commission Questions & Answers –document https://health.ec.europa.eu/system/files/2022-06/qa_safetyfeature_en_0…

 

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