The Falsified Medicines Directive (FMD) and associated Delegated Regulation introduces measures which aim to prevent the entry of falsified medicines into the legal pharmaceutical supply chain by enabling the verification and authentication of medicines as they move through the supply chain to patients. It includes using tools such as 2D barcodes, and anti-tampering devices on pack of certain medicines, to ensure those medicines are real and intended for human use.
The regulation includes expectations for pharmaceutical manufacturers and supply chain stakeholders to work together across Europe to establish a system where the identification and authentication of medicines are guaranteed throughout European (EU) countries.
In the UK, key representative bodies from across the medicines supply and distribution sector have created an informal alliance, the UK ESM FMD Partners, to drive forward the implementation of this regulation. Today sees the launch of a four-week consultation for interested parties to provide feedback on the proposed User Requirement Specifications (URS) for the UK Medicines Verification System (UKMVS) as required by the Delegated Regulation (EU) 2016/161 of 2 October 2015. The consultation also introduces a Framework Memorandum of Understanding (MOU) that has been developed and agreed between the principle UK pharmaceutical supply chain associations who will take on the responsibility for its management under the supervision of the UK competent authority.
When the consultation closes on Wednesday 13 July, the UK will have better understanding of the wider view of key representative bodies and associations on the proposed model.
The key UK representative bodies or associations are:
ABPI Press OfficeEmail: email@example.com Telephone during work hours (9am to 5pm Monday to Friday):+44 (0) 20 7747 7147 or +44 (0) 20 7747 1441Telephone out of hours (5pm to 9am and weekends):+44 (0) 20 7747 1445
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. We represent companies supplying around 90 per cent of all medicines used by the NHS, and are researching and developing the majority 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.