FMD checks in Britain will cease from December 31

Latest

FMD checks in Britain will cease from December 31

In Latest

Community pharmacies in England, Scotland and Wales are to switch off or disconnect from their FMD systems by December 31, the UK Falsified Medicines Directive Working Group has said, though pharmacies in Northern Ireland will carry on verifying and decommissioning FMD-compliant medicines.

A statement from the Working Group (WG) yesterday (Monday November 16) said contractors should ensure their integrated pharmacy systems are no longer actively connecting to or seeking a response from the UK's medicines verification hub at the end of the year.

The WG said that as the UK has left the European Union and with the Transition Period ending on 31 December 2020, some regulatory requirements will no longer apply in Great Britain, although certain EU legislation will continue to have effect in Northern Ireland under the Northern Ireland Protocol for at least four years, at which point the protocol is due to be reviewed.

Among the requirements ceasing to have effect in GB are the ‘safety features’ elements of the EU Falsified Medicines Directive (FMD, 2011/62/EU) and Delegated Regulation (2016/161). This means that pharmacies and other end users such as wholesalers will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs.

The WG said that end users in Great Britain will be disconnected automatically from the UK National Medicines Verification System (UKMVS) run by SecurMed UK, making it no longer be possible to verify and authenticate packs from January 1 2021. 

Integrated pharmacy systems will still be able to use batch details, expiry dates or product details (GTINs) from packs’ 2D barcodes while these packs are still in circulation. However, pack serial numbers will no longer have any function. Packs will 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 December 31 2020 for end users in Great Britain.

Northern Ireland remains connected

End users in Northern Ireland will remain connected to the UKMVS and will need to continue to verify and decommission any packs with the FMD safety features in line with the requirements of relevant EU and UK medicines legislation.

SecurMed UK has confirmed it will continue to provide end user registration and support to end users in Northern Ireland. 

The UK has agreed with the EU a phased implementation over the next 12 months of medicines regulations and importation requirements for medicines moving from GB to NI, with industry guidance due to be published soon. 

Potential new UK system

The Medicines and Medical Devices Bill, which is 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 WG says. "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." 

Responding to the statement, Gareth Jones, head of corporate affairs at the National Pharmacy Association, said: "Introducing FMD has been a slow process – and one that is still not complete. The Medicines and Medical Devices Bill is nearing the end of its passage through parliament – this will provide government with the power to introduce requirements for a national system to protect the medicines supply chain from counterfeits.

"The end of FMD in Great Britain provides an opportunity to deliver the patient safety benefits of an anti-counterfeiting system - but in a way that is more flexible and in line with the way that medicine supply works in the UK. There are different ways to prevent counterfeit medicines reaching patients – pharmacy level scans at the point of supply is just one option.

"Ultimately, any effective system needs to protect patients and deter counterfeiters, without imposing a disproportionate burden of time and cost."

Record my learning outcomes

Latest

Inspiring stories related to health, fitness and the pursuit of wellbeing

Share:

More like this

bookmark_icon_off
Latest

Locate a Locum Learning launched

Locate Learning launches today, increasing members access to extensive learning library.

1 Min Article

bookmark_icon_off
Latest

MHRA issues thermometer warning

MHRA issues thermometer warning after increase in the number of unreliable products available in the UK. 

1 Min Article

bookmark_icon_off
Latest

Nearly 90 per cent of adults would have tested positive for Covid-19 antibodies in June, says ONS

ONS estimates vast majority would have had antibodies in mid-June.

1 Min Article

bookmark_icon_off
Latest

New NHS clinics to provide pelvic floor support for women

Pregnant women and new mums are to receive support from new NHS clinics.

1 Min Article

bookmark_icon_off
Latest

NICE recommends mental health support for people with acne

Mental health support is key in managing acne vulgaris, says clinical watchdog.

1 Min Article

bookmark_icon_off
Latest

RPS calls for action on women's health inequalities

Action is needed to reduce the inequalities faced by women when accessing health services, the Royal Pharmaceutical Society has said. 

1 Min Article

bookmark_icon_off
Latest

Reports of potential bidding war over LloydsPharmacy

LloydsPharmacy could be the target of a three-way bidding war fought among financial investors over the next few weeks, it has been reported.

1 Min Article

bookmark_icon_off
Latest

Dukes to leave PSNC in September

PSNC chief executive Simon Dukes will leave his post at the end of September after just over three and-a-half years in the role.

1 Min Article

bookmark_icon_off
Latest

NHSE: Pharmacy must speak 'as one' to gain power

Community pharmacies need to speak 'as one' to gain greater influence within primary care, a senior NHS England official has said. 

1 Min Article

bookmark_icon_off
Latest

E-cig loophole puts minors at risk, Government told

A charity criticises the government for failing to close a loophole allowing companies to hand out free e-cigarettes to under-18s. 

1 Min Article

bookmark_icon_off
Latest

Lloyds pulls nasal spray over 'bold' Covid claims

LloydsPharmacy has "paused" sales of a £15 nasal spray that claims to neutralise the coronavirus before it can make people ill.

1 Min Article

bookmark_icon_off
Latest

DH sets ambitious targets for winter flu programme

The Department of Health and Social Care announces that it aims to vaccinate 85 per cent of people aged 65 and over against influenza.

1 Min Article

bookmark_icon_off
Latest

Wright review group to hold focus groups to form proposals

The Wright review steering group will hold a series of online focus groups and workshops this month and in August.

1 Min Article

bookmark_icon_off
Latest

Two Solihull pharmacists jailed for illegal supply of POMs

Dean Dookhan and Narvinder Nandra pleaded guilty to two charges concerning the illegal supply of 21,000 Zolpidem pills.

1 Min Article

bookmark_icon_off
Latest

Pharmacist to run London marathon for charity

Pharmacist Mohammed Hussain will run the London marathon to raise money for Pharmacist Support.

1 Min Article

bookmark_icon_off
Latest

Boots opens flu jab bookings as demand soars

Boots says it has opened bookings for its winter flu jab service amid reports of soaring demand. 

1 Min Article

bookmark_icon_off
Latest

Running app downloaded over five million times this month

The Couch to 5K app contains advice and information from a celebrity coach to help users record their progress. 

1 Min Article

bookmark_icon_off
Latest

Drug companies fined £260m for "excessive and unfair" price hikes to hydrocortisone tablets over a 10 year period.

1 Min Article

bookmark_icon_off
Latest

IBS sufferers worried about return to workplace

People with irritable bowel syndrome are anxious about lockdown easing and the prospect of going back to the workplace contributing to their symptoms.

1 Min Article

bookmark_icon_off
Latest

GPhC too soft on corporate multiples claims PDA

The GPhC is disproportionately tough on individual registrants compared to pharmacy owners and premises, the PDA has claimed. 

1 Min Article

Recommended Learning

bookmark icon off
Sponsored education

Treating acid reflux and heartburn in the pharmacy

Understand how omeprazole 20mg works to treat heartburn and acid reflux symptoms

2 Min Module

bookmark icon off
Sponsored education

Managing hay fever: help meet your customers' needs

This module will improve your hay fever knowledge, helping you to understand its impact on sufferers and recommend the right products to ease symptoms

15 Min Module

bookmark icon off
Sponsored education

Fungal Nail Roundup

Complete this short interactive module to refresh your knowledge on identifying and treating fungal nail infections, and discover more about a product you can recommend to customers.

5 Min Module

bookmark icon off
Sponsored education

Challenge your thinking on warts and verrucas

Discover different treatment options for warts and verruas and when to recommend them to your customers, based on their individual needs

17 Min Module

bookmark icon off
Sponsored education

Managing heartburn and indigestion in the pharmacy

Learn how to identify and help customers manage heartburn and indigestion, from recommending the right products to ease symptoms, to self-care advice and identifying red flags for referral

10 Min Module

Sponsored education

Constipation: Making effective recommendations

Learn how to help customers with constipation and find out how even brief conversations can have a positive influence on their health.

15 Min Module