GovWire

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 UKs 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:

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 Governments priority is the continued supply of safe medicines to p

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