The Health Products Regulatory Authority (HPRA) notified the public on 2nd Oct 2019 that the serialisation “Use and Learn” phase will end on a phased basis from 31 January 2020. This announcement impacts Manufacturing Authorisation Holders (MAHs), Manufacturers and Wholesalers and the HPRA have issued an advice document “FMD Use and Learn Period in Ireland to End on Phased Basis from 31st January 2020”. The document can be viewed at the following link:
Delegated Regulation (EU) 2016/161 came into effect on 09 February 2019 and outlines detailed requirements for the application of safety features on the packaging of medicinal products for human use. This delegated regulation supplements the Falsified Medicines Directive 2011/62/EU.
It was acknowledged at both a national and European level that, due to the complex nature of implementation of this new regulation across the globe that a pragmatic approach to this implementation since its effective date was authorized. A “Use and Learn” approach was endorsed for the initial period of implementation in order to ensure the continuity of safe supply of medicines to patients.
On 8th April 2019 the “Use and Learn” phase was extended to 9th September 2019. In July 2019 the European Medicines Verification Organisation (EMVO) issued a position paper reflecting the current status of compliance to the European Commission Delegated Regulation (EU) 2016/161.
According to this position paper, it was estimated that 40% of all applicable Manufacturers and 25% of other ‘Supply Chain actors’ or stakeholders including Wholesalers, Hospitals and Pharmacies had not connected to the medicines verification system. This was 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 who have connected with the EU hub can be found at the following link: https://emvo-medicines.eu/pharmaceutical-companies/connected-companies/
On 2nd September 2019 a further statement was issued by the HPRA indicating that the “Use and Learn” phase would be extended beyond September 2019. The most recent communication has announced that the “Use and Learn” period will end on a phased basis from 31 January 2020.
The HPRA advice document acknowledges and identifies that significant progress has been made since the serialisation implementation date in February and specifically states that “the alert rate (number of alerts vs number of scans) has fallen from a high of 20% to 1.6%” and that “the understanding of the root causes of alerts and how to eliminate avoidable errors has increased significantly. The information gathered from all the scans and alerts generated to date has been crucial for this to happen.”
The key message in the HPRA advice document is that all previous communication issued in relation to the “Use and Learn” phase is still applicable. Once the “Use and Learn” phase ends, “every single alert will have to be investigated and the risk of the pack being falsified must be ruled out before it can be supplied”.
The HPRA advice document outlines the most common issues that have been detected throughout the “Use and Learn” phase as follows:
- Pack data for FMD packs not correctly uploaded by MAHs to the national system via EU Hub;
- Pharmacy, Wholesaler and hospital FMD software issues leading to incorrect barcode data being sent to the national system
- Scanners incorrectly configured
- Simply mistakes during scanning such as:
- Trying to decommission when in verify mode
- Decommissioning packs that are already decommissioned
- Decommissioned packs being returned to Wholesalers
The Irish Medicines Verification Organisation (IMVO) has been established to manage the medicines verification system for Ireland and the vast majority of Pharmacies, Wholesalers, MAH’s and Manufacturers have registered with the IMVO. IMVO will continue to work closely with all stakeholders throughout the remainder of the “Use and Learn” phase. A national procedure is due to be published which will include guidance on the roles and responsibilities of all stakeholders including where responsibilities lie for investigation and close out of alerts.
If you would like an independent assessment of your current serialisation status PharmaLex can conduct a gap assessment and identify corrective actions to support successful implementation of serialisation within your organisation. To discuss the range of services that we offer, please connect with us on +353 1 846 4742 or email us at firstname.lastname@example.org