Implementing ‘safety features’ under the Falsified Medicines Directive

Falsified medicines present a threat to public health in several ways, such as adverse reactions, interaction with other medicines and loss of faith in healthcare systems. Currently there is no mechanism that allows users to verify where a medicine has come from. The European Union (EU) Falsified Medicines Directive (FMD) aims to prevent falsified medicines from entering the legitimate supply chain and reaching patients. The ‘safety features’ policy requires a unique identifier and tamper-evident features to be added to prescription medicine packs by 9th February 2019. 

The EU FMD (2011/62/EU) introduced new harmonised measures to ensure that medicines in the EU are safe and that medicines trade is controlled properly. Member States now have until 9th February 2019 to implement the final part of the Directive; the ‘safety features’ Delegated Regulation.

The Medicines and Healthcare Products Regulatory Agency (MHRA) consultation invites views on the proposed steps that the Government intend to make to ensure that the United Kingdom (UK) meet its obligations to transpose the provisions of the FMD that requires ‘safety features’ to appear on the packaging of certain medicines. The consultation closes at 3pm on 23rd September 2018.

The rules for the ‘safety features’, which are set out in detail in Commission Delegated Regulation (EU) 2016/161, are as follows:

  • A unique identifier (a 2D data matrix code and human readable information) that must be scanned at fixed points along the supply chain.
  • An anti-tampering device allowing verification of whether the packaging of a medicinal product has been tampered with.

The ‘safety features’ element of the FMD is an end-to-end verification system, therefore data linked with individual packs will be uploaded into the repository at the time of manufacture and the data will be decommissioned when supplied to patients. Medicines will be authenticated on a risk-based approach through the supply chain with verification and decommissioning (which involves changing the active status of the product in the national and European repositories to prevent any further verification) taking place before the product is supplied to the patient.

The consultation document aims to: explain the scope of the policy in relation to the ‘safety features’; explain the flexibilities within the Delegated Regulation, where the UK can determine policy decisions to accommodate the complexities within the UK medicines supply chain; present the Government’s proposed approach to implementation; consult on the available options for implementation and provide stakeholders with a list of questions to assist understanding of the best way to implement this policy. The consultation is accompanied by a Statutory Instrument (SI) that aims to implement the requirement for ‘safety features’ to appear on the packaging of certain medicinal products and an Impact Assessment (IA) which focuses on the areas of the regulation where the UK has flexibility to refine the implementation approach.

Article 2 of the Delegated Regulation sets out the scope of products that are required to have the ‘safety features’ as follows: prescription medicines, unless they are listed in Annex I of the Delegated Regulation; non-prescription medicines listed in Annex II of the Delegated Regulation and medicinal products to which Member States have extended the scope of the application of the unique identifier or of the anti-tampering device.

The consultation should be read by those in the UK who will be affected by the proposed changes, thus this includes but is not limited to: the pharmaceutical industry, wholesalers, patient groups, other regulatory authorities, the National Health Service (NHS) and persons authorised to supply medicines to the public.

The UK remains a full member of the EU until exit negotiations are concluded, therefore all the rights and obligations of EU membership remain in force. The EU Withdrawal Bill will help ensure that, as far as possible, the same rules and laws will apply in the UK after exit day as the day before. The Bill aims to convert existing direct EU law such as EU regulations into UK law as it applies in the UK at the date of exit from the EU. The Bill will also preserve the laws that have been made in the UK to implement EU obligations, for example laws already made to implement the FMD, and the Delegated Regulation being consulted now, which will apply in UK law from 9 February 2019. The Government aims to finalise implementation plans on areas covered within the consultation later in 2018.

To read more about implementing ‘safety features’ under the FMD, please click here.