EU-FMD: Post-deadline challenges do not mean the end of new sales

Last week saw the official launch of the national drug verification system in Bulgaria as part of the Europe-wide EU-FMD EMVS go-live. This is a great step forward for the country and its manufacturers in meeting the changes in legislation. At a press conference, at the launch, our Senior Director Ian Haynes, spoke to put the European approach into perspective and talk about the wider challenges presented by counterfeit medicines.

The issue: counterfeit medicine

Counterfeit drugs not only affect the brand owners through loss of revenue and reputation, but fake medication hurts real patients, sometimes fatally. Counterfeit products have also been shown to be leading to an increased resistance to some medication, such as some malaria products and antibiotics.

The Solution: serialization

Serialization, i.e. to assign a unique identifier on each pack, helps to secure the supply chain, it establishes a fundamental basis for traceability as product moves through the supply chain. The EU-FMD milestone of 9^th February 2019 is therefore clearly not the end of this process, but just an important milestone along the way to the full system being operational.

The fact that 80% of global pharmaceutical worldwide sales is already subject to serialization requirements, will allow for optimising the supply chain, clearer visibility and monitoring of operations. There will also be retail and healthcare benefits including increased safety of patients, optimising recalls and returns, as well as additional patient support. Although there are risks with any large amount of data, this is a great opportunity for the healthcare industry to exploit this digital asset to enhance the industry and its patients.

The Next Steps: continued compliance

Unfortunately, counterfeit drugs will not disappear overnight, but the EU-FMD is a strong regulation that will protect this industry and patients. To listen to the conference in full, Ian Haynes, speaks from approximately the five-minute mark and can be viewed here: http://www.bta.bg/bg/live/show/id/0_z9xs86ep

Excellis Europe work with manufacturers and businesses throughout the supply chain, as well as the regulatory authorities and solution providers that are providing the technology solutions for the supply chain participants. There will still be many changes and challenges with the EU-FMD regulations, contact Excellis Europe today to find out how we can help your business continue to be compliant. https://www.excellishealth.eu/contact-us/