The European Commission published the Falsified Medicines Directive (Directive 2011/62/EU amending Directive 2001/83/EC) to improve patient safety by mandating supply chain stakeholders to strengthen aspects of the supply chain, alongside the addition of obligatory safety features on the outer packaging of certain medicines – essentially all prescription medicines.
This includes significant expectations on all Marketing Authorisation Holders in the UK as outlined by the associated Delegated Regulation (EU 2016/161 published in February 2016) which defines the characteristics and technical specifications of the safety features, which include:
- a ‘unique identifier’ which enables the identification of individual packs
- the addition of ‘anti-tampering devices’, which would indicate corruption of the pack
- the funding of a stakeholder-established IT system which enables the verification of each pack of medicine as it moves through the supply chain to patients
The Delegated Regulation, and the new medicine verification system it lays down, will apply as of 9 February 2019.
65 Gresham Street
Attendance via webinar also available
Wednesday 17 October 2018
11:00 - 15:30
As part of ongoing ABPI/BGMA engagement with the legislation, we are pleased to provide members and wider industry with a briefing from the MHRA, SecurMed UK (the UK Medicines Verification Organisation) and EMVO (the European Medicines Verification Organisation).
Attendees have the opportunity to attend in person or join via WebEx, as detailed below.
- Are you aware of the obligations you face to ensure a continuity in your marketing authorisations post 2019?
- Are you satisfied with the progress made in the UK with regards to establishing the UK verification system?
- Are you confident as to how to on-board with the European Medicines Verification Organisation to enable your data to be downloaded into the pan-European database?
- Are you aware of the medicine Master Data requirements for download into the pan-European database?
- Are you engaging with the MHRA to understand their intentions for supervising the UK implementation of the Directive and sharing your own challenges?
To attend the briefing in person at the BGMA offices in London please register here.
To join via Webinar please register here.