Pharma: Falsified Medicines Directive, are you ready?

On the 19th of January 2016, Hague will be exhibiting at the Access to Safe Medicine conference organised by Reconnaissance International. The conference will focus on the new EU directive – the Falsified Medicines Directive and the Unique Identifier – which will be enforced in 2019.

In a worldwide market where 1 in 10 drugs is said to be counterfeit, the directive focuses on the tracking, security and safety requirements including the Unique Identifier and the tamper-evident seal on drugs packaging.

The EU Falsified Medicines Directive, what is it all about?

Adopted in 2011, The EU Falsified Medicines Directive 2001/83/EC stated that:

  • Prescribed medicines should bear, on their outer packaging, a specific number and anti-tampering device
  • The active ingredients should be manufactured according to appropriate quality standards, whether they are manufactured in the EU or imported
  • Online legitimate pharmacists should carry the same logo across the EU so consumers could make an informed choice

On the 2nd October 2015, the European Commission submitted a supplement to the Directive detailing specific rules on the safety features applied on the outer packaging of medicinal products to be enforced in 3 years’ time.

By 2019, every pharmaceutical company operating in the EU will have to meet serialisation and verification requirements. In a nutshell, it means that the outer packaging of any medicine will require to carry the following features:

  • Security features which make it possible for wholesalers and professionals who have the responsibility to prescribe medicines to the public to verify the authenticity of the medicine and identify single packs
  • A device which makes it possible to check if the outer packaging has been tampered with

Drugs manufacturers as well as companies repackaging medicines produced by another manufacturer must comply to the Directive.

Tamper-verification features, where to start?

Tamper-proof pharmaceutical packaging can carry a range of security features which indicate that the outer-packaging has been opened or tampered with. There are however strict conditions about the tamper-evident features used. For example, the tamper-evident seal must not prevent the readability of the information and the text on the packaging must remain readable after the pack has been opened.

The tamper verification features will enable wholesale distributors and drugs’ prescribers such as doctors, nurses and pharmacists to check easily if the packaging has been tampered with.

The directive clearly states the technical requirements for the application and features of the seal. It is therefore recommended that manufacturers get in touch with packaging and labels manufacturers to implement a solution that suits them whilst complying with the new directive.

How we can help?

Expert in security print solutions with years of experience, Hague provides a comprehensive range of security solutions dedicated to the pharmaceutical market. We work closely with our clients to understand their requirements and offer expert advice on how we can protect their brand.

Our security products are compliant with the new EU directive and include multi-component labels combining a number of overt and covert security features into a single label, 3D holograms and track and trace technology.

Contact us or come to our stand on the 19th of January at the Access to Safe Medicine conference to discuss how we can help you to get ready for 2019 and protect your brand.