Guidance

Application of the Falsified Medicines Directive: Safety Features in Northern Ireland

How to prepare for implementation and compliance of the Safety Features Regulation.

From:
Medicines and Healthcare products Regulatory Agency
Published
24 October 2018
Last updated
14 November 2022 — See all updates

Introduction

This page provides information for stakeholders on the application of the Falsified Medicines Directive (FMD) delegated regulation (2016/161) on Safety Features. Included is:

  • Guidance on the supply of medicinal products to different markets
  • Information on actions to take in the event of suspected falsification
  • Additional useful information

How the Falsified Medicines Directive works

The EU Falsified Medicines Directive (2011/62/EU) (FMD) was adopted in 2011 and introduced new harmonised measures to ensure that medicines in the European Union (EU) are safe and that trade in medicines is properly controlled.

The final part of the Directive, the ‘safety features’ Delegated Regulation (EU) 2016/161 came into force on 9 February 2019, and applies to certain categories of prescription only medicines (POM) and certain named non-prescription medicines.

Following the UK’s departure from the EU, the ‘safety features’ Delegated Regulation (EU) 2016/161 no longer applies in Great Britain (England, Scotland and Wales) but still applies in Northern Ireland.

The European Commission produced a video to explain more about the safety features.

These safety features are:

  • a unique identifier (a 2D data matrix code and human readable information) which will be placed on medical products that can be scanned at fixed points along the supply chain
  • tamper evident features (anti-tampering devices) on the pack

The unique identifier comprises:

  • a product code which allows the identification of at least:
  • the name of the medicine,
  • the common name
  • the pharmaceutical form
  • the strength, the pack size
  • the pack type
  • a serial number which is a numeric or alphanumeric sequence of a maximum of 20 characters randomly generated
  • a batch number
  • an expiry date

If the member state to which the medicine is being supplied requires it, the unique identifier will also need to include the national reimbursement number. This is not applicable in the UK.

The unique identifier must be printed on the pack in a 2D data-matrix code and be printed in a way in which the information can be read by the human eye.

The choice of tamper-evident feature to be used is for the marketing authorisation holder (MAH) to decide. A European Standard is available with guidance on the types of tamper-evident features which could be considered by MAHs. This is titled ‘Tamper verification features for medicinal product packaging EN 16679:2014’. MAHs are required to place the safety features on the packaging of medicines which fall within the remit of the delegated regulation and upload the data into European Medicines Verification System (EMVS) prior to placing the product on the market.

The 2D barcode is scanned at various points in the supply chain to verify that it is an ‘authentic’ medicine. Upon supply to the patient in the EU or Northern Ireland, the unique identifier must be ‘decommissioned’ via a scan from the FMD system, to prevent any duplication of a legitimate identifier for use on a falsified medicine. This will be checked against data in the national repository, which for Northern Ireland is the UKNI Medicines Verification System (UKNI-MVS) run by SecurMed UK.

Guidance and useful resources

Supply of medicines to GB and NI

Medicines with a marketing authorisation valid only in Great Britain (PLGB) do not require a Unique Identifier (UI), however, we encourage companies to retain the tamper evident device. Amendments to packaging mock-ups to remove placeholder references to serialisation data, including the UI, from PLGB packs can be made at the next regulatory submission and there is no need to a submit a specific labelling update application.

No pack data upload to the European Medicines Verification System (EMVS) is required.

Medicines with a marketing authorisation (MA) valid in Northern Ireland (PL and PLNI) require a Unique Identifier and a tamper evident device on each pack. Pack data for these products must continue to be uploaded to the EMVS.

This is in line with guidance provided by the European Medicines Verification Organisation (EMVO) Letter of Announcement Clarifying the uploading requirements for packs intended for supply in Northern Ireland, dated 22 February 2021.

A derogation from the delegated regulation is in effect meaning that the Unique Identifiers on packs with a marketing authorisation valid in NI, supplied by a manufacturer or wholesaler in the EEA do not require decommissioning when exported to the UK. This supports the flow of products through Great Britain to Northern Ireland. Unique Identifiers on these packs should be decommissioned in Northern Ireland as required by EU Delegated Regulation 2016/161.

The above derogation on decommissioning upon export from the EEA is in place until 31st December 2024. The MHRA and Department of Health and Social Care (DHSC) will ensure reasonable notice is provided in the event that any of these arrangements are to change.

Verification of Medicines Packs Supplied to Northern Ireland

It is recognised that wholesalers established in Northern Ireland require practical guidance on the actions to be taken to verify safety features on medicines to comply with the obligation set out in the Human Medicines Regulations 2012.

As a condition of holding a wholesale dealers’ licence in Northern Ireland, regulations 42 (4) and (5) of the Human Medicines Regulations set out the provisions of Commission Delegated Regulation 2016/161 that must be complied with relating the safety features appearing on the packaging of medicinal products for human use.

Article 20 of Commission Delegated Regulation 2016/161 states:

“A wholesaler established in Northern Ireland, Cyprus, Ireland or Malta shall perform adequate verifications to ensure that shipments of medicinal products manufactured and labelled for the United Kingdom market comply with the requirement to bear safety features under Article 54a(1) of Directive 2001/83/EC when received from the manufacturer, the marketing authorisation holder (MAH) or a wholesaler who is designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf.”

Actions to be taken by NI wholesalers to verify medicines:

The MHRA considers that, as a minimum, NI Wholesalers should take the following steps to ensure medicines are adequately verified:

Quantity supplied from a GB based wholesaler/MAH/manufacturer Minimum risk-based verification required at receiving wholesaler
Pallet level supply of stock: Complete pallet of 1 batch 1 pack to be verified per pallet to confirm status
Pallet level of supply of stock: More than 1 product or batch per pallet 1 pack of each product or batch to be verified per pallet
Complete box outer 1 pack of each box to be verified
Loose individual packs Each pack to be verified

Where a product is shipped as an inter-company transfer to NI from a GB wholesaler, no additional verification of stock is required. All medicines delivered to a GB wholesaler will have been examined upon receipt and as such there is an expectation that they are correctly authorised for the UK market and originate from approved suppliers.

Export of medicines to non-EEA countries

Holders of wholesale dealer authorisations in Great Britain no longer have access to the UKNI MVS and are therefore no longer obliged to decommission packs upon export.

Holders of wholesale dealer authorisations in Northern Ireland continue to have access to the UKNI MVS and should continue to decommission packs upon export to non-EEA countries, including Great Britain, in line with the delegated regulation.

Future plans for a UK Wide national verification system

The Government has committed to explore all options for a national system to ensure that UK patients will continue to be protected from the public health threat posed by falsified medicines. We are committed to fully consulting with stakeholders on the future development of a national falsified medicines scheme that is the best fit for our national supply chain.

Implementation and enforcement

The UK is committed to meeting the requirements of EU FMD safety features Delegated Regulation in Northern Ireland, and we expect all stakeholders in the supply chain to comply with these requirements.

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. 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 and DHNI will also be taking a pragmatic, flexible approach to how we enforce the 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.

Error messaging and false alerts

Medicinal products manufactured and released before 9 February 2019 may have had the safety features applied but may not have been 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.

MA holders are reminded of the requirements in Article 33 of Commission Delegated Regulation 2016/161, in particular to upload information to the repositories system before the medicinal product is released for sale or distribution by the manufacturer, and the offence in regulation 94A of the Human Medicines Regulations for failure to comply with those requirements,.

There have been a number of occurrences of “A2 – Batch Not Found” alerts generated in the UK/NI medicines verification system (NMVS) due to batch data not being uploaded prior to batches being released to market. This is an area of focus for the MHRA as we look to drive down the number of such alerts.

Where the MAH 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.

Any instances of suspected falsification (including physical signs of tampering) are to be reported in the usual way via the Yellow Card reporting system.

Further information and explanation of explaining the alert management process may be found on the EMVO website.

Guidance on checking Italian and Greek FMD compliant stock

There are two countries (Italy and Greece) that are yet to implement the 2D barcode UI system. Where the 2D barcode UI is not in use it is the responsibility of the licence holder importing the product into the UK to identify falsified, stolen or recalled stock, including those that have already been decommissioned.

Italian stock

The Italian Medicines Agency (AIFA) have issued updated guidance on the security label used by Italy, the ‘bollino’.

This system uses a serial number on a 2-layered adhesive sticker/label which can be tracked via a central database and must be applied to each pack. The upper label is removed upon dispensing in Italy leaving a voided area and strip containing the repeated serial number.

The complete Italian bollino label (2 layers) must be present on the outer carton of packs exported from Italy. Furthermore, the exported packs should bear a nullification mark (e.g., an “ESPORTAZIONE” stamp or a cross over the barcode).

The MHRA have been made aware of packs that do not have the full 2 layers of the bollino label or packs on which the bollino has been falsified and is not of the correct appearance. AIFA state that both a missing bollino or products bearing a falsified bollino should be considered as a falsified medicine and reported.

If there are anomalies with missing bollino or bollino labels showing different features from those described in the guidance document, please contact [email protected], who will check the legitimacy of the products.

Legitimacy of labels can also be checked using the Italian Ministry of Health’s drug package verification website.

Italian Medicine Agency guidance (PDF, 3.61MB, 2 pages)

Greek stock

Greece operates a similar, two-layer system where the unique identifier (pack serial number) is placed upon an authenticity sticker carrying a linear GS1 128 serialised barcode plus an EAN 13 product barcode. The labels fluoresce under UV light and have holograms of varying designed embedded within them. As with the Italian system, the adhesive top layer sticker would be removed when the product is dispensed in Greece to reveal an exposed area where it was once located.

Example of a Greek FMD barcode.

These barcodes are decommissioned in the Greek system upon dispensing or export. The Greek National Organisation for Medicines (EOF) has also developed and disseminated through its website a software application which can be used for tracing individual product packs.

The link below can be used to check if specific stickers are valid and correspond to the physical medicinal products that are affixed to:

Authenticity label check

Reporting suspected falsified medicines

Any falsified medicines identified should be reported through the Yellow Card reporting system [Report a FAKE or Counterfeit]. For FMD applicable Prescription only Medicines (POM) products containing the Unique Identifier (UI) 2D bar code the following information is needed: A report of an alert for one of these packs should include:

  • the alert number in the following format: “GB-xxxxxxxx-xxxx-xxxx-xxxx-xxxxxxxxxxxx” and the following details from the pack itself:
  • GTIN
  • serial number
  • batch id
  • expiry date

Ideally this would be with images of the pack showing all 4 elements in human readable format AND the 2D barcode. The alert could be generated for any of the following codes upon verification or decommissioning;

  • NMVS_FE_LOT_03
  • NMVS_FE_LOT_12
  • NMVS_FE_LOT_13
  • NMVS_NC_PC_01
  • NMVS_NC_PC_02
  • NMVS_NC_PCK_19
  • NMVS_NC_PCK_22

For FMD applicable products without a Unique Identifier (UI) 2D bar code from Italy or Greece the following is needed:

  • supplier details
  • product particulars
  • photographs (to include the side where the adhesive stickers / labels should have been present
  • date received

Updates to this page

Published 24 October 2018
Last updated 14 November 2022 + show all updates

  1. Update to FMD guidance

  2. Update to post-Brexit protocols

  3. Added a notice to the top of the page, explaining that the content of this page will be updated in the following weeks following the Northern Ireland Protocol coming into effect after the end of the transition period.

  4. Change to wording under 'Italian stock' as well as updated guidance links.

  5. Updated link to PHE information on PHE-supplied vaccines under FMD.

  6. Updated Italian Medicine Agency guidance

  7. Additional guidance on checking Italian and Greek FMD compliant stock

  8. Added Jan 2019 pdf attachment Amended wording.

  9. Added links to external information in the Guidance for all stakeholders section.

  10. Added information on the implementation of safety features.

  11. Published guidance for wholesalers, guidance for parallel import license holders and a link to guidance related to Medicines Homecare.

  12. Minor update to dates of government consultation including when response was published.

  13. Published Additional guidance on Article 23 providers, Healthcare Institutions and Article 26 exemption.

  14. First published.

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