Healthcare & Pharmaceutical Awards 2018
October 5, 2018
EU-FMD: Post-deadline challenges do not mean the end of new sales
February 18, 2019

Excellis Europe produces a guide to EU-FMD Compliance

GIRP, in collaboration with Excellis Europe, release guidelines to EU-FMD for wholesalers

Christoph Krähenbühl Senior Director at Excellis Europe Ltd and Monika Derecque-Pois Director General at  GIRP — European Healthcare Distribution Association

Saturday 9 February 2019 will mark a major milestone in the evolution of the medicines supply chain in Europe. On this date a Europe-wide process to verify medicines, based on the European Medicines Verifications System and the Point-of-Dispense Verification process, will go live across Europe.

The European medicines supply chain starts with the manufacturing process and continues through the distribution system, all the way to the consumer: the patient. The pathway is multi-layered and involves all levels of the supply chain. It is important to understand all areas of your business’s responsibility.

The entire pharmaceutical sector ­– from manufacturers to pharmacies, including every organisation in the supply chain – will have to comply with the requirements established in the Falsified Medicines Directive (FMD) legislation. These requirements include the mandatory verification of each pack in pharmacies and hospitals and a range of obligations on the participants in the pharmaceutical supply chain, including full-line wholesalers who process tens of thousands of medicines packs in their distribution centres in every country in Europe every day.

Meeting membership needs

GIRP – the European HDA (Healthcare Distribution Association), representing full-line wholesalers and other parties including Pre-Wholesalers/3PLs – has taken the lead among the European medicines supply chain stakeholders to recognise the needs of their membership for information and guidance. They have met these needs by publishing a concise and constructive guide to what the EU-FMD means throughout the pharma supply chain and outlining the critical requirements to these stakeholders.

We are proud that GIRP has chosen Excellis Europe as the expert consulting partner to produce this guide. The guide provides much-needed background information for the reader to understand the basis of these industry altering regulations, as well as a detailed explanation on how this affects all businesses and suppliers in the pharma supply chain.

A global serialization consultancy

Excellis Europe are the world’s leading pharma serialisation experts, and unique in having worked with both the leading stakeholders in the Europe and the US to define the documents used widely, the US (HDA Barcoding Guideline) and the EU HDA (Guideline to EU-FMD). The unrivalled understanding that Excellis have allows us to deliver innovative solutions in master data management, data visualisation and customer relationship management amongst others. The GIRP guide shares this expertise by guiding you through the challenges of implementing EU-FMD readiness and advising on the increasing pressure to improve patient safety, reduce healthcare costs and the other demands on the pharma supply chain.

Download the report here:

Follow us and GIRP on social media platforms to keep up to date with all serialisation traceability requirements and future reports, involving content such as any future requirements from the EU-FMD and best practices once established.

Twitter: @3CExcellis

LinkedInExcellis Europe Ltd

Twitter: @GIRPBrussels


Show all

Leave a Reply

Your email address will not be published. Required fields are marked *