Guidance

Implementing the Falsified Medicines Directive: Safety Features

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

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.

Member States have until 9 February 2019 to implement the final part of the Directive, the ‘safety features’ Delegated Regulation (EU) 2016/161).

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, and 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 (note that 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 Delegated Regulation does not specify which tamper-evident feature should be used.

The choice of tamper-evident feature to be used will be for the marketing authorisation holder (MAHs) to decide. A European Standard is available which gives 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’.

The Delegated Regulation comes into force in 2019. MAHs will be required to place the safety features on the packaging of medicines which fall within the remit of the Delegated Regulation no later than 9 February 2019.

Manufacturers will place the safety features on the packaging of prescription only medicines and upload the data into the European repository system prior to placing the product on the market. The 2D barcode will need to be scanned at various points in the supply chain to verify that it is an ‘authentic’ medicine.

On supply to the patient, 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 in the UK is run by SecurMed UK.

MHRA and the Department for Health and Social Care will continue to publish further guidance to inform all stakeholders throughout the supply chain as it becomes available. To suggest any non-Government guidance for inclusion on this page please email FMD.safetyfeatures@mhra.gov.uk.

Guidance and useful resources

Guidance for all stakeholders

European Commission Delegated Regulation on Safety Features

Government consultation on the implementation of Safety Features (ran from 16 July to 23 September 2018). The Government response to the consultation is expected to be published in autumn 2018.

European Commission Q&A on Safety Features for Medicinal Products for Human Use (published September 2018)

European Commission letter to stakeholders on their obligations under the Delegated Regulation

SecurMed, the providers of the UK Medicines Verification System

Technical notices regarding the impact of Brexit on the Life Sciences

NHS Digital overarching guidance

Guidance on reporting suspected falsified medicines will be linked to in this section

Devolved administrations

This guidance does not apply to British Overseas Territories, which are out of scope of the legislative changes, but does apply to The Crown Dependencies and the devolved administrations, which can be contacted directly for further information

Manufacturers, Marketing Authorisation Holders and Parallel Importers

MHRA guidance on how to apply to register safety features

MHRA guidance for parallel import license holders will be linked to from this section

Heads of Medicines Agencies (CMDh) clarification on the implementation of FMD (April 2018)

ABPI’s FAQ’s for pharmaceutical manufacturers

Information on the “Introduction of the European Medicines Verification System (EMVS)” from the EMVO will be linked to from this section.

Information and fees for onboarding with the UK Medicines Verification System via SecurMed

Wholesalers

MHRA guidance for wholesalers will be linked to in this section

Community pharmacies

FMD guidance for community pharmacies: “The way forward for Community Pharmacies”

Hospitals and hospital pharmacies

CQC guidance will be linked to from this section

SPS ‘FAQs Secondary care services and FMD

NHS guidance on secondary care

Further information for NHS organisations on FMD can be requested by emailing fmd@nhs.net

HMG guidance on the definition of Healthcare Institutions will be linked to from this section.

GPs

Additional guidance from the British Medical Association will be linked to from this section.

Homecare

Medicines Homecare relates to specialised medicines prescribed by hospitals and supplied, often via a third party, to patients in community settings.

The Medicines Homecare guidance will be linked to from this section.

Providers not part of a healthcare institution, clinic or health centre – subject to final Government position on Article 23

SPS ‘FAQs Secondary care services and FMD

Health and justice

Guidance and FAQ’s for health and justice will be linked to in this section.

FMD newsletter

MHRA publish the FMD Newsletter to all MAHs and Wholesale Dealers Licence holders when new information and guidance is available.

Safety Features Newsletter July 2018 (PDF, 70.8KB, 3 pages)

Safety Features Newsletter March 2018 (PDF, 72.9KB, 2 pages)

Safety Features Newsletter February 2018 (PDF, 110KB, 2 pages)

Safety Features Newsletter November 2017 (PDF, 69.5KB, 2 pages)

Safety Features Newsletter October 2017 (PDF, 72.9KB, 2 pages)

Safety Features Newsletter September 2017 (PDF, 71KB, 2 pages)

Safety Features Newsletter August 2017 (PDF, 88.3KB, 2 pages)

Safety Features Newsletter April 2017 (PDF, 95.4KB, 2 pages)

Safety Features Newsletter March 2017 (PDF, 110KB, 2 pages)

Safety Features Newsletter February 2017 (PDF, 98.1KB, 2 pages)

Safety Features Newsletter January 2017 (PDF, 122KB, 2 pages)

Please send items for inclusion in the newsletter to FMD.safetyfeatures@mhra.gov.uk.

Published 24 October 2018