Falsified medicines are recognised as an increasing problem in the EU and the USA where illegal online pharmacies provide the main route of distribution supplying up to 50% of all falsified medicines, according to a WHO-estimation. In the developing world, falsified medicines account for up to 30% of the market share.
The EC have recognized the severity of this problem and successively implemented legislation aimed at blocking falsified medicines from entering the supply chain. The EU Falsified Medicines Directive - first published in 2001 (2001/83/EC) and amended in 2011 (2011/62/EU) - concerns three main areas:
To ensure GMP-consistent supply chains in non-EU countries, the FMD specifies strict rules for Audits, Quality Technical Agreements and Quality Management Systems.
The EU Delegated Regulation EU/2016/161 provides the specific details of the safety features. It will be implemented on 09 February 2019 and applies to new obligatory safety features that will be required on packaging. In general, only prescription medicines are concerned. Annex I and II, however, contain lists of OTC medicines to which the legislation applies (the “black” list) and exempt prescription medicines (the “white” list).
These are the unique identifier (UI) and an anti-tampering device, now defined in the EMA QRD template.
The UI is well defined. It consists of a 2-D barcode (must comply with ISO 15495) which contains:
Inclusion of a National reimbursement number is optional and country specific. Information contained in the 2-D barcode needs to be additionally included in alphanumeric writing.
The advantage of the UI system is that it allows for end-to-end verification of a medicine at various stages of the supply chain. Manufacturers upload data to a centralised EU hub which distributes requested information to National databases in real time.
The anti-tampering device is technically not particularly specified so manufacturers can decide on exact technical implementation, depending on the packaging used (e.g. label-seals or tear-off strips).
The responsibility for setting up robust IT systems in EU supply chains has been placed with stakeholders, and so National Repositories have been set up to store all the details of medicines bearing the new safety features. Implementation of these systems remains a major challenge and will probably provide opportunities for improvement well beyond February 2019.
In order to help users determine whether an online Pharmacy is legitimate or not, the EC have introduced the clickable logo. It redirects the user to the NCA website, containing a list of approved online retailers.
EUDRAC is currently working with its clients to implement the required safety features and liaising with national repositories who are working with supply chains in different Member States, such as SecurMed UK. For more information, please contact one of the Eudrac offices.