• Skip to main content
  • Skip to primary sidebar
  • Home
  • News
  • Events
  • Education
  • Interviews
    • Career spotlight
  • Opinion
    • Professional Dilemmas
    • Patient perspective
  • PIPcast
  • Jobs
  • Business Directory

Pharmacy in Practice

EDX/20/1154
Date of prep: December 2020

Prescribing information and
adverse events reporting

For healthcare professionals only

Falsified medicines directive to end due to Brexit

17th November 2020 by PIP editor Leave a Comment

 

Now that the UK has left the European Union and the Transition Period ends on 31st December 2020, the regulatory requirements surrounding the Falsified Medicines Directive will no longer apply in ‘Great Britain’.

 

In a statement this week the UK FMD Working Group for Community Pharmacy said that the ‘safety features’ elements of the EU Falsified Medicines Directive and Delegated Regulation 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.

 

European Union legislation will continue to have effect in Northern Ireland under the Northern Ireland Protocol.

 

In a statement released this week by the UK FMD Working Group for Community Pharmacy they commented:

 

“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.

 

“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 UKMVS. 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.

 

“The UK participated in discussions with the EU to agree a phased implementation of medicines regulations in Northern Ireland, under the NI Protocol, by 1 Jan 2022. The UK published a statement, agreed with the EU, on 5 Nov 2020 confirming a 12-month phased implementation of the Falsified Medicines Directive and regulatory importation requirements for medicines moving from GB to NI.

 

“Work is continuing with the EU to agree on operational specifics.

 

“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 enable 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.”

 

 

 

 

Share this:

  • Click to share on LinkedIn (Opens in new window)
  • Click to share on Facebook (Opens in new window)
  • Click to share on Twitter (Opens in new window)
  • Click to share on WhatsApp (Opens in new window)
  • Click to share on Telegram (Opens in new window)
  • Click to email this to a friend (Opens in new window)

Related

Next article  Second wave of pharmacies join vaccination effort in England

Filed Under: News Tagged With: Falsified Medicines Directive, FMD

Register for our upcoming webinar and live Q&A

About PIP editor

Pharmacy in Practice is a UK pharmacy publication with its roots in Scotland.

Reader Interactions

Begin the discussion right here Cancel reply

Primary Sidebar

Categories

Follow Us

  • Twitter
  • LinkedIn
  • Facebook
  • Instagram
  • Twitter

PIP business directory

Letters to the editor

Letters to the editor

Community pharmacists can identify high-risk asthmatic patients

Pharmacists severely limited without patient record access

It is difficult to know how to ask a patient if they can read

We don’t ask patients about their medicines as often as we should

More letters to the editor here...

Blogs

💊 PIP live pharmacy blog

Winter stresses must not ‘destabilise’ general practice

What is it like to depend on medicine to treat endometriosis?

Opinion

Why is pharmacy not integral to government mass vaccination plans?

Pharmacy Covid-19 vaccination involvement is a ‘no-brainer’

The great patient medication returns debacle

CPD Challenges

💊 CPD Challenge: How well do you understand pulmonary embolisms?

💊 CPD Challenge: Prescribing and dispensing clozapine

💊 CPD Challenge: Oral anticoagulants – Dabigatran

More CPD challenges here...

© 2021 · About Pharmacy In Practice · Site mantained by Mike

This site is for healthcare professionals, please confirm you are a healthcare professional to continue.

YES

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
Pharmacy In Practice uses cookies, by continuing to use this site we will assume you are ok with that Find out more.