In 2011, the European Commission (EC) published Directive 2011/62/EC, the Falsified Medicines Directive (FMD). The main objective was to support the fight against counterfeit medicines. The new Directive had a big influence on the pharmaceutical supply chain. It introduced numerous Delegated Acts requiring certain safety features (Unique Identifier and Anti-Tampering Device), had some impact on the revisions numerous chapters of the EU-GMP Guidelines and led to a complete revision of the EU-GDP Guidelines.

Serialisation: A New Guidance for EU Inspectors

In 2016, Commission Delegated Regulation (EU) 2016/161 was officially published. This laid down detailed rules for the safety features which came into force on the 9th of February 2019. Good Manufacturing Practice (GMP) inspectors started looking into the implementation during their site inspections. The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the regulation.

The following questions have been listed in the document focus, for example:

  • Connection with hub and On-Boarding Partner (OBP)
  • Data Flow
  • Generation of Serial Numbers (SNs)
  • Uploading of information in the repositories system
  • Application of the Anti-Tampering Device (ATD)
  • Packaging Lines
  • Composition, Decommissioning, status change of the Unique Identifier
  • Quality of the printing of the 2D barcode
  • Alert Management

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Source: https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/inspection_gmp_aidememoire_en.pdf