Traceability, Falsified Products & New Legislation

Why is Product Traceability so important today?

Product traceability has become an extremely prevalent issue in recent years, particularly in relation to the pharmaceutical, medical devices, dental, cosmetic, food and tobacco industries.

The issue of traceability has increased in importance recently for many reasons. One of the most critical reasons is the issue of falsified products entering the supply chain and in some cases, reaching the end user/customer. The consumption of these falsified products, particularly in the pharmaceutical, medical devices and dental industries, has caused serious health problems, grave injuries and in the most critical cases, even death to one or more individuals.


Falsified and Counterfeit Pharmaceuticals

According to the United States Food and Drug Administration, they estimate that counterfeits make up more than 10% of the global medicines market.[1]

The World Health Organization (WHO) also estimates that more than 50% of medication and pharmaceuticals purchased online are falsified.[2]


New Legislation: Pharmaceutical Traceability

As a result of the increase in the number of falsified products being created, sold and consumed by customers, a range of different legislation has been drafted. This legislation is in the process of being implemented at the moment, in various guises, in different countries throughout the world.

This legislation relates to the requirement for serialisation and the ability to assign unique identifiers to individual packs, at dispensing unit level, of certain medication in order to try to curb the entry of falsified pharmaceuticals into the legitimate supply chain. These products can be falsified by either their identity, history or source.[3]


New Legislation: Falsified Medicines Directive (FMD) (Directive 2011/62/EU) - EU

In Europe, the most important legislation with regard to pharmaceutical traceability is the Falsified Medicines Directive (FMD) (Directive 2011/62/EU). The Falsified Medicines Directive was published on the 1st July 2011 and was designed to amend the previous directive 2001/83/EC which was implemented on the 6th November 2001.[3]

The 1st July 2011 marked the beginning of the transposition of the FMD legislation, by the various EU member states, into their own national legislation. This new legislation became applicable on the 2nd January 2013 by which time transposition of the legislation by member states into national legislation was completed.[3]


Pharmaceutical Tablets

Falsified Medicines Directive Measures

According to the European Commission:

"The new legislation introduces tougher rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled.[3]

The new legislative measures of the FMD include:

  • An obligatory authenticity feature on the outer packaging of the medicines. This feature will be decided at a later stage via a delegated act.
  • A common, EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union.
  • Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients.
  • Strengthened record-keeping requirements for wholesale distributors.[3]

According to the FMD, all prescription-only medicines will be required to have safety features including the unique serial number, at dispensing unit level, and also tamper evident packaging. Some specific products or product categories may be exempt - this is to be decided at a later date under delegated acts.[4]


Difference between Falsified and Counterfeit Medicines

According to the European Commission, there is a difference between falsified and counterfeit medicines.

Falsified Medicines
  • These fake medicines that pass themselves off as real, authorised medicines.
  • They may contain ingredients, including active ingredient, which are of low quality or in the wrong dosage - either too high or too low.
Counterfeit Medicines
  • These are medicines that do not comply with EU law on intellectual and industrial property rights, such as registered trademarks or patent rights.
  • The Falsified Medicines Directive (Directive 2011/62/EU) does not legislate for counterfeit medicines.[5]


Implementation timelines for measures under the FMD

The ballpark implementation timelines for the various measures are:

  • Legislation came into force: 2nd January 2013
  • Provisions for import of active substances: 1st July 2013
  • Safety Features: 3 years after relevant delegated act
  • Internet common logo: 1 year after relevant delegated act


Delegated Acts

The delegated acts in relation to the Falsified Medicines Directive under evaluation currently with various concept papers submitted for public consultation. Some of these delegated acts are due to be published during 2014 depending on the progress of the different public consultations.

Essentially, this new legislation will lead to significant changes for manufacturers, wholesalers and distributors of pharmaceutical products, with a particular focus on the requirement for serialisation and the individual identifier to be required at dispensing unit level.[7]


New Legislation: Drug Supply Chain and Security Act (DSCSA) - USA

The next blog in this series will deal with the American legislation in relation to counterfeit pharmaceuticals. i.e. The DSCSA - Drug Supply Chain and Security Act, which was signed into law in the USA by President Barack Obama on the 27th November 2013.[8]


[1]European Commission: Conference Paper: “Sanofi-Aventis Takes Action Against Counterfeiting”, [Online] Available From:, [Accessed: 28th April 2014]

[2]World Health Organization: Medicines: General Information on Counterfeit Medicines, [Online] Available From:, [Accessed: 28th April 2014]

[3]European Commission: Health: Human-Use: Falsified Medicines, [Online] Available From:, [Accessed: 28th April 2014]

[4]GS1: Download Files: Healthcare Files: White Paper: “EFPIA & GS1: a shared vision for product identification in the context of the EU Directive on Falsified Medicines” [Online] Available From:, [Accessed: 28th April 2014]

[5]European Union: Press Releases: “Q&A False Medicines Directive”, [Online] Available From:, [Accessed: 28th April 2014]

[6]European Medicines Agency: Document Library: Presentation: “Implementation of Falsified Medicines Directive”, [Online] Available From:, [Accessed: 29th April 2014]

[7]MHRA: How We Regulate: Medicines…:The False Medicines Directive: Safety Features, [Online] Available From:, [Accessed: 30th April 2014]

[8]FDA: Drug Safety…:Drug Supply Chain and Security Act, [Online] Available From:, [Accessed: 28th April 2014]