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NHS Digital and stakeholders from across the medicines supply chain are working together to implement a national system to ensure compliance with the FMD. We are led by the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA), and collectively known as the National Competent Authority (NCA).
We have been commissioned to develop guidance toolkits for healthcare providers to help them prepare for the implementation of FMD.
It is the responsibility of healthcare institutions to ensure that they have a suitable system in place for FMD decommissioning. Queries relating to the implementation of FMD policy should be directed to the MHRA. Healthcare providers can also contact IT system suppliers directly for information.
Guidance on safety features: 7 February 2019
The United Kingdom is committed to meeting the 9 Feb 2019 deadline for the launch of EU FMD safety features delegated regulation, and we expect all stakeholders in the UK supply chain to be aiming to comply with these new requirements, indeed we know much of the UK supply chain is already prepared.
Despite the significant work undertaken to date in the UK and given the complexities associated with setting up the medicines verification system across the EU it is anticipated issues will arise especially during the initial operational/implementation phase. It is important that these issues do not compromise confidence in the medicines supply chain. The government’s priority is the continued supply of safe medicines to patients.
For example, several member states have formally advised those who may receive ‘unknown’ error messages to dispense anyway. Therefore, the MHRA will also be taking a pragmatic, flexible approach to how we enforce the new legal requirements, as long as the normal checks are carried out, and there is no reason to think that the medicine is falsified. This position will be kept under review.
We are also aware of issues around non-FMD compliant packs released to market before 9 February 2019, and wholesalers’ designated status, We will continue to work with UK stakeholders to help bring them into full compliance with the safety features regulation as soon as possible.
Error messaging and false alerts
Medicinal products manufactured and released before 9 February 2019 containing safety features may not necessarily be fully uploaded to the repositories system. There are also packs of medicines already on the UK market which contain 2D barcodes that do not relate to the FMD safety features due to other international initiatives. Attempts to verify or verify and decommission these products will trigger system alerts. This situation may continue for a period of time due to the shelf life of medicinal products, in some cases up to five years. Where Alert IDs are triggered please refer to the guidance published by the Royal Pharmaceutical Society and the UK FMD working group.
Any instances of suspected falsification (including physical signs of tampering) are to be reported in the usual way via the yellow card scheme using the ‘fake’ button.
Where the Marketing Authorisation Holder is notified by the alerting system that a data error has occurred, they are to notify the MHRA if upon further investigation, falsification is suspected.
Further background explaining the alert management process on the EMVO website
Toolkits are available for the following care settings:
- Secondary care toolkit, including organisations that hold a Wholesale Dealers Licence (WDL) or Wholesale Distribution Authorisation (WDA)
- Community pharmacy toolkit (v0.1)
- Dispensing doctors Toolkit (v0.1)
- GP surgery toolkit (v0.1)
- Out-of-hours services (v0.1)
- Additional guidance on ‘Article 23 providers’, ‘Healthcare institutions’ and ‘Article 26 exemption
Each toolkit will highlight a number for supply chain scenarios that are common across that care setting and identify all possible points at which verification and decommissioning could happen.
The purpose of these toolkits is to inform and prepare staff in various care settings for the implementation of FMD. The majority of care settings that receive and supply medicines will need to implement FMD for verification and decommission purposes.
The toolkits can be used to assist each individual healthcare setting identify the most suitable place to verify/decommission based on their needs and inform staff of what they need to do to successfully implement FMD and be compliant. In addition the toolkits can also provide useful links to other sources of relevant FMD information.
The Directive on the Falsified Medicines was legislation passed by the European Union Parliament, which aimed to increase the security of the manufacturing and delivery of medicines in Europe and provide protection to patients from falsified medicines in the legal supply chain of pharmaceuticals.
Under the FMD, all new packs of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features:
The unique identifier must be carried in a 2D data matrix code. The information contained within this is specified in the Delegated Regulation. The information in the 2D code must also appear on the package in human readable format. Often this will appear where the batch number and expiry date are currently located on the packaging. Sometimes due to the size of the carton it will not be possible to accommodate this information as currently and other solutions will be needed. Exceptionally the information may be split over different faces of the carton.
The human readable information with the 2D data matrix code can appear in any order. Any descriptive terms may be used provided it is clear what is being referred to. Where necessary the prefix descriptive terms may be located above or adjacent to the information
Verification: can take place at any time during the movement of the medicine through the supply chain. It is a check within the repository (IT database) of the data held which ensures that the product is authentic and originates from a legitimate manufacturer.
Decommissioning: takes places at the end of the supply chain when the product is being supplied to the patient and changes the status of the unique identifier in the repository to indicate that the pack has been supplied– so that any other pack bearing the same unique identifier cannot successfully be verified/or decommissioned.
Minimal technology specifications – scanner
The Falsified Medicines Directive (FMD) delegated regulation requires those who supply medicinal products to verify their authenticity via a decommissioning process. Decommissioning involves reading (scanning) a unique 2D bar code printed on every manufactured medicinal product pack.
When you are looking for a scanner, look for these decode capabilities.
What drugs need to be scanned
Prescription Only Medicines
These drugs need to be verified and decommissioned, with the exception of those excluded, see below.
General Sale List Medicines (GSL) pharmacy medicines
Non prescriptions medicine are not included under FMD. They do not need to be decommissioned or verified. The exception to this is the OTC Omeprazole.
Article 23 exemptions
Article 23 of the delegated regulation provides member states with legal flexibility regarding their respective supply chains about where the decommissioning process should take place for
persons or institutions captured under Article 23 (‘Article 23 providers’). This list is made up of the following Article 23 providers:
(a) persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy
(b) veterinarians and retailers of veterinary medicinal products;
(c) dental practitioners
(d) optometrists and opticians
(e) paramedics and emergency medical practitioners
(f) armed forces, police and other governmental institutions maintaining stocks of
medicinal products for the purposes of civil protection and disaster control
(g) universities and other higher education establishments using medicinal products for the purposes of research and education, with the exception of healthcare institutions
(k) nursing homes.
The purpose of this toolkit is to inform and prepare staff throughout secondary care for the implementation of the Falsified Medicines Directive (FMD).
The purpose of this toolkit is to inform and prepare staff members throughout community pharmacy for the implementation of the Falsified Medicines Directive (FMD).
This toolkit prepares and informs dispensing doctors and any associated staff on the implementation of the Falsified Medicines Directive (FMD).
This toolkit gives information to GPs and medicine administering practice staff inform GPs and medicine administering practice staff on the implementation of the Falsified Medicines Directive (FMD).
The purpose of this toolkit is to prepare and inform out-of-hours GPs and associated staff on the implementation of the Falsified Medicines Directive (FMD).
This document which provides additional information for stakeholders considering whether an organisation is covered under Article 23, needs to fulfil decommissioning obligations as a healthcare institution or a community pharmacy, or meets the requirements for exemption under Article 26.