Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

FMD

MHRA confirms it will consider UK version of Falsified Medicines Directive

With less than a month until the Falsified Medicines Directive (FMD) is implemented on 9 February 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that if there is a no-deal Brexit it will consider a UK-only version of the EU law.

In a government response to a 2018 consulation on the implementation of ‘safety features’ under the FMD, the MHRA said that “in the interests of public safety, we will evaluate the options around a future national falsified medicines framework”.

The statement, published on 24 December 2018, supports what Claymore Richardson, senior policy manager at the Department of Health and Social Care, told delegates at the Pharmacy Show in October 2018. Richardson told delegates that it would be “common sense” to build on work already done to create a UK version of FMD legislation in the case of a no-deal Brexit.

If the UK leaves the EU without a deal, access to the EU database — including the European Medicines Verification System (EMVS), which is the heart of FMD compliance — will be revoked. The MHRA had previously said that since FMD compliance is impossible without access to the EMVS, legal obligation to adhere to FMD regulations “would be removed for actors in the UK supply chain” in the event of a no-deal departure.

Some pharmacies in the UK are already FMD compliant: on 11 November 2018, a pack of insulin was thought to be the first medicine to be decommissioned under FMD procedures at Aintree University Hospital NHS Foundation Trust. Shortly afterwards, Market Pharmacy in Bolton was thought to be the first UK community pharmacy to decommission a medicine.

The National Pharmacy Association has advised pharmacists to prepare themselves for FMD but to “avoid signing long-term contracts” with FMD solution providers.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206001

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 1 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £138.50Buy now
  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 2 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £262.50Buy now
  • International Research in Healthcare

    International Research in Healthcare

    Guidance for students or researchers undertaking a multi-centre research project in health services, medicines use and professional practice.

    £38.00Buy now
  • Drugs in Use

    Drugs in Use

    Optimise drug therapy for your patients. These case studies help you bridge the gap between theoretical medicines knowledge and practical applications.

    £43.00Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.