Falsified Medicines Directive Enforced in the UK

Craig Stobie from Domino Printing Sciences shares on how to prepare for FMD and other emerging legislation.

The Falsified Medicines Directive (FMD) has finally been transposed into UK legislation. The FMD came into force on 20 August 2013. “It is now time for pharmaceutical manufacturers to walk the talk,” said Craig Stobie, global life sciences sector manager at Domino Printing Sciences.

Compliance with the directive, aimed at safeguarding patients by preventing the infiltration of falsified medicines into the legal supply chain, has always been a race against time, noted Stobie, but now, UK manufacturers must stop playing the waiting game and start working with suppliers. However, according to Stobie, there are no solid examples for manufacturers to learn from given that there are only a few pilot projects that have achieved the full extent of the FMD. “Hence, building on trusted relationships with suppliers and industry experts will enable manufacturers to make confident decisions on how best to comply,” said Stobie.

While it is tempting for companies to push investments costs into the next financial year, Stobie pointed out that it is key for manufacturers to realise that implementing serialisation is not a straightforward engineering job. “In some respects, it is similar to a regular installation, but in others, it’s vastly different.” For example, getting a serialisation-ready line back to ‘business as usual’ standards has proved to be a challenge in pilots, with high levels of rejects and low line speeds cited as key problems that take time to overcome.

However, it’s not all bad, said Stobie. “Item level serialisation as a result of the FMD, if done well, will raise overall equipment effectiveness levels. Moreover, in addition to improving consumer safety, it can potentially increase patient engagement, leading to improved adherence and patient experience.”

Stobie provided some insights on how to prepare for FMD and other emerging legislation. The first step is to get senior colleagues involved. Secondly, senior stakeholder engagement is essential because serialisation will impact most if not all business functions during implementation, with a dip in efficiency across all departments at real risk. “Getting your business leaders to understand this will go a long way to getting teams working together to make compliance a company goal,” said Stobie. Thirdly, companies should invest in training. “Make time to train engineers and operators in optimising lines and don’t be afraid to champion the idea of a pilot line for staff to work on,” Stobie added. Last but not least, companies must not be reluctant in sharing best practices. The directive is making an industry-wide impact and it will help to take a collaborative approach with other companies.

About EU Falsified Medicines Directive

Adopted in 2011 to prevent falsified medicines from reaching the open market within the European Economic area, the EU Falsified Medicines Directive (FMD 2011/62/EU) will no doubt change the landscape of the European pharmaceutical business model. The scope of the Directive places new obligations on all branches of the industry from manufacturers and generics producers to contract packers, re-packers and importers, amongst which is the unique identification of products at unit of sale level. Domino established a European Group in 2011 to help manufacturers comply with the Directive. The Group consolidates Domino’s expertise in pharmaceutical legislative compliance solutions and comprises specialists in disciplines such as legislative standards, validation of automated manufacturing good practice, code formats and serialisation.