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.email@example.com.
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
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
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
MHRA guidance for wholesalers will be linked to in this section
FMD guidance for community pharmacies: “The way forward for Community Pharmacies”
Hospitals and hospital pharmacies
CQC guidance will be linked to from this section
NHS guidance on secondary care
Further information for NHS organisations on FMD can be requested by emailing firstname.lastname@example.org
HMG guidance on the definition of Healthcare Institutions will be linked to from this section.
Additional guidance from the British Medical Association will be linked to from this section.
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
Health and justice
Guidance and FAQ’s for health and justice will be linked to in this section.
MHRA publish the FMD Newsletter to all MAHs and Wholesale Dealers Licence holders when new information and guidance is available.
Please send items for inclusion in the newsletter to FMD.email@example.com.