Cold Chain

Falsified Medicines Directive – Preparing for Global Compliance in Packaging and Labelling

Cold Chain

16:01, May 3 2018

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CTA’s Lu Tikrity explores the implications of the Falsified Medicines Directive as the deadline looms ever larger

With under a year to go before the Falsified Medicines Directive (FMD) comes into place in February 2019, are sponsor companies ready for its implementation? Will they meet the deadline and what happens after it has passed?

Reports are suggesting only 50 percent of pharma companies are prepared for the FMD deadline, which begs the question – what about the rest? There is a lot of uncertainty as to what happens once the deadline has passed. Although pharma companies feel prepared for the FMD, ensuring they're compliant is another matter. This usually takes 6-9 months, which means companies by now need to have started the implementation process in order to meet the deadlines.

As panic sets in, companies are realizing they will not be able to sell their products if the regulations are not met. Strong communication as well as seamless technologies will need to be put in place before the deadline to ensure there are no setbacks.

Every pharma/biotech firm needs to package and distribute their products, while doing so in compliance with a raft of stringent regulatory requirements. Global requirements will differ from country to country so gaining an understanding of international regulations is also vital.

SMEs and CMOs

While pharma companies are on their way to meeting the deadline, tighter budgets and fewer resources mean small to medium-sized enterprises (SMEs) and contract manufacturing organizations (CMOs) just aren’t ready. There is a lack of understanding as the whole implementation process is new which leads to a lack of readiness.

While a seamless system integration plays a key part in the implementation period, it’s imperative pharma and CMOs ensure there are no delays and that deadlines are met. A clear communication strategy between companies is more important than ever to ensure the smooth running of processes. Ensuring the correct technologies are in place and a clear understanding of regulations is key to successful implementation.

Smart Labelling

Adapting artwork to meet new regulations is a challenge a lot of pharma companies are faced with. The need for more information on smaller labels is an ongoing battle. Ensuring tamper-evident labels are also essential to meeting requirements. With so many technologies on the market, companies are moving towards e-labelling and QR codes to enhance patient interaction.

While different packaging designs are created, companies are constantly exploring how to both adhere to regulations and connect with patients through their packaging designs. New smart labelling techniques are allowing patients access to information through NFC (near field communications) technology. This allows patients to engage with the product and also meet the stringent requirements set out by the FMD.

Beyond Compliance

So you are all ready for implementation and meeting the FMD deadline in February, but what happens after the compliance date? While much focus has centred on preparation before the deadline, sponsors cannot lose sight of their responsibilities after the FMD has come into effect. 

A bulletproof rollout plan is essential to surviving in the industry. What's more, system integration needs to be seamless in order to avoid pitfalls and overcome challenges along the way. With an ongoing uphill battle, the first few months will be very testing for the pharma industry as it gets to grips with the new regulations.

Vendor Expertise

As the deadline nears, new and innovative technologies are needed for packaging. As well as adhering to guidelines, companies need efficiency in their supply chain.

There is a vast number of solution providers that offer smart packaging that adhere to regulations and meets patient requirements. Now, more than ever, pharma companies are relying on the expertise of solution providers to ensure implementation is successful and the deadline is met.

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