Use and Learn Period for Serialisation
The European Commission’s Delegated Regulation on safety features for medicinal products for human use became effective on 09 February 2019. Prior to 09 February 2019 the industry was busy preparing for implementation of this new regulation. Marketing Authorisation Holders (MAHs) were actively ensuring the incorporation of safety features (Unique Identifiers (UI) and Anti-Tampering Devices (ATD)) into packaging as well as registering with the National Medicines Verification Organisations (NMVO) and European Medicines Verification Organisation (EMVO). Manufacturing and Importation Authorisation (MIA) Holders were updating manufacturing processes and policies to allow for incorporation of the new safety features, including the reporting requirements. While Wholesale Distributors, hospitals and pharmacies have been updating computer systems to allow for communication with national databases and verification or decommissioning of UIs. The Health Products Regulatory Authority (HPRA) published an update on their website based on the national arrangements for the implementation of the EU Falsified Medicines Directive (2011/62/EU) Legislation on 05 February 2019. In this update, the HPRA outline that almost 2000 stakeholders across multiple disciplines (pharmacies, hospitals, pharmaceutical manufacturers and wholesalers, etc.) have collaborated to meet the implementation date of 09 February 2019, encompassing over 95 million medicines that are dispensed annually.
It has been 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 has been authorized. Therefore, a “Use and Learn” approach has been endorsed for the initial period of implementation in order to ensure the continuity of safe supply of medicines to patients.
The HPRA newsletter specifically outlines that:
- All medicinal products released by MAH’s for the Irish Market after 09 February 2019 should bear the safety features as required i.e. a tamper proof seal and 2D barcode.
- During the initial period of operation, the system will be considered to be in ‘Use and Learn’ phase. Therefore wholesalers, pharmacies and hospitals should scan medicines bearing the safety features and if an alert or any other unexpected message is flagged, should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine is involved.
- All alerts generated by the FMD system upon scanning a pack during this ‘use and learn’ phase will be forwarded by the system to the IMVO, the HPRA and the pharmaceutical companies so that they can be investigated and monitored.
- Notwithstanding the above, if a pharmacist or wholesaler has reason to believe that packaging has been interfered with, based on their examination of the anti-tampering device on the pack, they must report their concern to the HPRA (as a suspected quality defect via the usual reporting mechanisms) and not supply the pack.
The full newsletter can be viewed at the following link: http://www.hpra.ie/homepage/medicines/news-events/item?t=/eu-falsified-medicines-legislation-update-on-national-arrangements-for-implementation&id=c09e0b26-9782-6eee-9b55-ff00008c97d0#
The HPRA have also reiterated that suspected quality defects should follow the usual reporting procedures by completing the “Quality Defect Report” Form which can be found on the HPRA website and this should be sent to the HPRA as soon as possible.
Do you feel confident that you have successfully considered all aspects associated with serialisation now that the industry has gone live? If not, Pharmalex can support you and help you to assess the robustness, or identify potential gaps that may exist in your serialisation programme. If you would like further information or wish to discuss how PharmaLex can support you, please connect with us at +353 1 8466 4742 or email@example.com.