Consultation on how the Falsified Medicines Directive should be implemented
June 22 2016
A four week consultation has commenced asking how the European Falsified Medicines Directive should be implemented in the UK.
The Directive was introduced in October 2015 and aims to prevent the entry of falsified medicines into the legal pharmaceutical supply chain. It sets out “obligations on pharmaceutical manufacturers and supply chain stakeholders to establish a pan-European system where the identification and the authentication of medicinal products is guaranteed by the end-to-end verification of all medicinal products bearing the safety features.”
The system requires greater traceability on medicines including packs to contain a unique identifier code so they can be tracked through the supply chain, and anti-tampering packaging. All medicines will have to comply with the regulations by 2018.
Medicines manufacturer and supplier organisations in the UK have now come together to consult on the proposed User Requirement Specifications (URS) for the UK Medicines Verification System (UKMVS). The URS describes how the system will work, centred on a European hub which will serve as the principle storage place for master data and will be the gateway for transmitting manufacturer data to the national systems. It will also be where data reconciliation is done, so that original and repackaged products can be tracked throughout the EU.
Manufacturers will submit package unique identifier codes to the European hub, and as the product is repackaged or shipped between countries by parallel importers, the data will be scanned at a each stage for verification at the Europe hub. It also means that packs can be ‘decommissioned’ (eg withdrawn or shipped out of the EU) and stock can be reconciled, or products affected by alerts can be traced across different countries.
National systems will be verification platforms that pharmacies or other registered parties such as wholesalers, self-dispensing doctors or hospital pharmacies can use to check a product’s ‘authenticity’. All data necessary to perform this and other relevant transactions will be stored in the respective National Systems.
The consultation is asking for views on the URS and in particular:
- any discrepancies with the requirements of the Delegated Regulation (EU) 2016/161;
- any concerns regarding the overall architecture of the EMVS and in particular the key tasks of the National System;
- any disagreement with the Governing Principles;
- any disagreement with the Design and Implementation Principles;
- any critical gaps in the major functions or additional requirements as outlined;
- any additional user requirements, specific to the needs of a UK verification system;
- any priority ‘use cases’ not currently listed.
Members of the informal alliance, UK ESM FMD Partners, conducting the consultation are the ABPI (research-based pharmaceutical industry representatives), BAEPD (parallel distributor representatives), NPA and CCA (dispensing entity representatives) and HDA (wholesaler representatives).
Consultation documents https://app.citizenspace.com/ukmvo/consultation-on-the-ukmvs-urs