Serialisation – Enforcement and Proposed Inspections

The Commission Delegated Regulation (EU) 2016/161, which outlines detailed requirements for the application of safety features on the packaging of medicinal products for human use, came into effect on 09 February 2019.  The provision of a ‘Use and Learn’ or ‘stabilisation’ phase in a number of countries appears to have resulted in the delayed implementation of the Directive across the EU. For example, in Ireland the ‘Use and Learn’ phase has been extended to the 09 September 2019, seven months after the ‘go live’ date.

According to a position paper issued by the European Medicines Verification Organisation (EMVO) in July 2019, it was estimated that 40% of all applicable manufacturers and 25% of other ‘supply chain actors’ or stakeholders including wholesalers, hospitals and pharmacies have not connected to the medicines verification system. This is despite efforts by the EMVO to educate key stakeholders through participation in technical workshops, meetings and sharing of information on the EMVO website. The full list of manufacturers which have connected with the EU hub can be found at the following link:

As the EMVO are a non-profit organization they cannot enforce the stakeholders to interact with the relevant systems. Thus, the EMVO are now encouraging the National Competent Authorities (NCAs) in each state to start enforcing the primary requirements of the falsified Medicines Directive (FMD) by conducting regulatory inspections to monitor compliance. Furthermore, the EMVO have highlighted a number of key compliance issues:

  • Full IT stabilisation of the system(s)
  • Supply chain actors who are not connected to the system at all
  • End-user IT software providers
  • Manufacturers connected but not uploading data
  • End-users connected but without configuring scanners, establishing procedures and/or proper training for staff
  • End-users connected but not scanning serialised pack

At the time that the EMVO position paper was published, approximately 3% of all scans were identified as ‘false alerts’ whereas the target alert level is 0.05%. The aim therefore is that once all ‘supply chain actors’ are fully compliant with the requirements of the new directive, there will be a decrease in the number of alerts which will in turn eliminate the requirement for the ‘Use and Learn’ phase.

To read the position paper in full, including details regarding the key areas for compliance as proposed by the EMVO, follow the link below:

PharmaLex can support key personnel within your organisation in the implementation of serialisation readiness. Alternatively, if you require an independent assessment of your current serialisation status PharmaLex can conduct a gap assessment and identify corrective actions to support successful implementation of serialisation. To discuss the range of services that we offer, please connect with us on +353 1 846 4742 or email us at

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