Falsified Medicines Directive: responding to the engineering challenges


With the deadline for the Falsified Medicines Directive looming, Shaun Baker, Managing Director of Newman Labelling Systems, answers some of the most commonly asked questions about the engineering challenges involved

Falsified Medicines Directive: responding to the engineering challenges

Falsified medicines are fake medicines that are made to look like genuine, authorised medicines. However, they often contain little or no active ingredients, poor quality or incorrect ingredients and can have fake or tampered packaging. These medicines are a real health threat as they are not scrutinised for the usual evaluation of quality, safety and efficacy, which is legally required for sale in the EU. The Falsified Medicines Directive was introduced in July 2011 in an effort to protect patients and consumers from these counterfeit medicines. In the UK, this regulation comes into force in February 2019.

Who does the Directive affect?

The Directive holds significance for all those involved in the supply chain — be it the suppliers of active ingredients, pharmaceutical manufacturers, contract packers or distributors.

What are the key changes under the Falsified Medicines Directive?

The Directive will introduce new and tighter regulation to protect medicines, with the requirement for two mandatory safety features on the packaging of medicines to enable them to be verified and authenticated at each stage of the supply chain:

  • a unique, non-predictive serial number and information that can be read by people and machines alike, often at high speeds. The unique identifier must be placed in a 2D barcode and contain the product code, a serial number, the national reimbursement number (if requested by Member States), the batch number and an expiry date. Furthermore, each serial number must be registered with a pan-European database
  • tamper evident features on the pack.

What challenges can businesses expect to face?

Upgrading existing production facilities to meet the new Falsified Medicines Directive raises a number of challenges, including the following:

  • a requirement for expert IT resources and significant investment in software and data handling
  • existing production line control systems may not have the capability to handle the new level of synchronisation that the Directive requires
  • additional printing demands can require larger or booklet-style labels and the requirement to upgrade or replace existing process machines
  • additional processes, such as tamper evident labelling, will need to be incorporated into existing packaging lines.

The deadline is approaching fast and, if existing systems need to be upgraded or replaced, then businesses need to act now.

What steps can businesses undertake to minimise the impact caused by these challenges?

First, evaluate the existing production line capability and performance to ensure it can cope with the extra requirements that the Directive will place on it. If necessary, printing and vision systems should be installed to enable an individual code to be applied to each label, as well as read and operate at high speeds (up to 350 cpm). Integrating this inline, as part of the labelling system, offers flexibility and efficiency at this stage of the process. Secondly, ensure that any upgrade maintains — or improves — the efficiency of the line. For example, it is important to consider what to do in the event that a label is “faulty” (the printed data is incorrect or the data is missing, for example). As each label is individually coded, then the traditional method of tracking a faulty label, applying it to a container and eventually rejecting the container is no longer a secure and efficient method.

In this case, a solution such as Newman Labelling’s Faulty Label Removal (FLR) System provides the solution to this problem — it removes the label from the web before it’s applied to a container. If the system does not receive “good signals” from the scanning devices in use (including barcode readers, missing overprint detectors, OCV cameras and 2D matrix code readers), the faulty label is securely removed from the label web prior to application onto the container. Faulty labels are then transferred to a paper roll for batch reconciliation and inspection.

The Falsified Medicines Directive represents a considerable change for the industry; the type of data that the pharmaceutical industry provides, and the means of handling and storing the data, will be affected. The IT challenge is one major aspect; but, don’t forget the engineering challenge involved — physically printing and applying individual codes to labels whilst maintaining line efficiency and labelling quality.