Key representative bodies in the UK medicines supply and distribution sector have recently reached an important stage in ensuring the continued safety of patients across the UK.
The management Boards of the ABPI, BAEPD, BAPW, NPA and PFNI have approved an Interim Memorandum of Understanding (MoU) which will underpin the implementation of the European Falsified Medicines Directive (FMD). The FMD introduces, by the end of 2018, mandatory, harmonised pan-European safety features, in the form of tamper evident packaging and a unique identifier to prevent falsified or counterfeit medicines reaching patients.
The interim MoU captures the stakeholders’ support for the adoption of the European stakeholder model (ESM) as a solution to the requirements of the Directive and associated Delegated Act. The ESM provides a Pan – European model, which will allow the required product verification and authentication. The BGMA has recently joined the ESM and supports the approach taken by the other representative bodies.
The stakeholders will be working with the RPS, regulatory and competent authorities and other relevant stakeholders, to enable the authentication and verification of medicines before they are dispensed to patients, thereby improving the integrity of the UK medicines supply chain.
For more information on the development of the UK medicines verification system, please contact Rick Greville, Director, ABPI Wales Cymru & Distribution Supply.
The stakeholders are:
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.
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