The Falsified Medicines Directive is legislation passed by the European Union Parliament, which aims to increase the security of the manufacturing and delivery of medicines across Europe and protect patients and prevent falsified medicines from entering the supply chain.
Now that the UK has left the EU, some regulatory requirements associated with FMD will no longer apply. However, all EU legislation relating to medicines will continue to have effect in Northern Ireland under the Northern Ireland Protocol.
FMD in Great Britain
- The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 Statutory Instrument outlines changes to regulations around the use of medicines in the UK.
- The requirements placed on all actors in the GB supply chain from 9 February 2019, by virtue of the Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regarding the safety features aspects of the Falsified Medicines Directive are removed by this instrument, according to the Explanatory Memorandum (Article 7.32).
- The EU legislation requires that the Unique Identifier on medicines coming from the EU be decommissioned (made inactive) on export from the EU to a third country (Article 22 – EU Delegated Regulation).
- There will be no obligations on the GB supply chain to affix safety features or to scan packs of medicines however, packs that already have FMD safety features will continue to be accepted in the GB, provided that they are in line with other GB packaging requirements.
- The MHRA is encouraging companies to retain the tamper evidence device on packs supplied to the UK.
- In the interests of public safety, the Government will evaluate the options for a future UK falsified medicines framework, considering the investment already made by stakeholders.
FMD in Northern Ireland
- Under the Northern Ireland Protocol (NIP), medicines in NI will be governed by EU rules and regulations. However, these rules are to be enforced by the UK’s medicines regulator, the MHRA.
- As a result of the NIP, the Falsified Medicines Directive will continue to apply and FMD ‘safety feature’ requirements will continue in NI from 1 January 2021. Packs with a marketing authorization (MA) valid in NI will require a unique identifier and a tamper evident device on each pack.
- The unique identifiers on packs with MA valid in NI (including UK-wide MAs) supplied from the EEA will not require decommissioning when exported to the UK until the 31 December 2021, according to MHRA guidance. The active unique identifiers on these packs should be decommissioned in NI at the time of dispense. Please note, the European Commission is considering extending this 31 December 2021 deadline for a further 3 years.
Pharmacies and Wholesalers in Great Britain
The ‘safety features’ elements of the EU Falsified Medicines Directive (FMD, 2011/62/EU) and Delegated Regulation (2016/161) cease to have effect in Great Britain from 31st December 2020. This means that pharmacies (and other end users such as wholesalers, hospitals and others handling or supplying medicines) will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs.
- End users in Great Britain will be disconnected automatically from the UK National Medicines Verification System (UKMVS) run by SecurMed UK. This means that it will no longer be possible to verify and authenticate packs from 1st January 2021. Pharmacy operators and system suppliers need to check that any integrated pharmacy systems with FMD functions are no longer actively connecting to or seeking a response from the UKMVS after the end of 2020. Stand-alone FMD systems can simply be turned off.
- Integrated pharmacy systems can still use batch details, expiry dates or product details (GTINs) from packs’ 2D barcodes while these packs are still in circulation. However, pack serial numbers no longer have any function. These packs remain valid and can be dispensed for as long as they are still in date.
- SecurMed UK will continue to provide end user registration and necessary support up to 31st December 2020 for end users in Great Britain.
Pharmacies and Wholesalers in Northern Ireland
Under the terms of the Northern Ireland Protocol, part of the UK’s Withdrawal Agreement with the EU, FMD will still apply in Northern Ireland, for at least four years (until the NI Protocol is due to be reviewed).
- End users in Northern Ireland will remain connected to the UKNIMVS. They need to continue to verify and decommission any packs with the FMD safety features (unique identifiers and anti-tamper devices) in line with the requirements of relevant EU and UK medicines legislation.
- SecurMed UK will continue to provide end user registration and necessary support to enable Northern Ireland end users to decommission packs with FMD identifier features in to 2021 and beyond.
The UK continues to participate in discussions with the EU to agree a phased implementation of medicines regulations in Northern Ireland, under the NI Protocol, as is evidenced by the recent publication of the UK Govt Command Paper, the EU COM Non-paper and the UK Govt Written Ministerial response:
Future national falsified medicines system
The Medicines and Medical Devices Bill (progressing through Parliament) would enable the Government to make regulations aimed at preventing falsified medicines from entering the medicine supply chain. This could include establishing a national system based on the unique identification of individual packs that enables medicines to be authenticated and identified if tampered with. The Government will have to consult with industry stakeholders, including pharmacy organisations, before introducing any new Regulations. No timetable has been set by the Government for consultation.
For more details, please contact Dr Rick Greville.