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

European Medicines Agency

Supply of more than 100 drugs could be disrupted by Brexit

Survey raises “major concerns” that 108 products may no longer be available after Brexit if changes are not made to marketing authorisations by 30 March 2019.

More than 100 medicinal products could be at risk of supply if marketing authorisation holders do not make the necessary changes to their marketing authorisations in time for Brexit, according to a survey from the European Medicines Agency (EMA).

When the UK leaves the EU in March 2019, some marketing authorisation holders will have to move processes from the UK to EU or European Economic Area (EEA) countries to ensure their authorisation remains valid. But according to companies’ current plans, changes may not be submitted in time for 108 (16%) of all 694 affected products, which the EMA said raises “major concerns” that if plans are not adapted, these products may no longer be available on the EU market.

The EMA contacted more than 180 marketing authorisation holders of 694 human and veterinary centrally authorised medicinal products located in the UK or who have quality control, batch release, importation sites or a qualified person for pharmacovigilance or pharmacovigilance system master files based in the UK. Over 90% of the marketing authorisation holders contacted responded to the survey.

The survey found that 400 medicines will require a transfer of marketing authorisation to a marketing authorisation holder based in the EU or an EEA member state. The majority of companies (94%) plan to submit their transfer applications by 30 March 2019, although this leaves 6% that might be submitted after this date.

A statement from the Association of the British Pharmaceutical Industry said that: “The EMA survey was carried out over six months ago, and we continue to stress the need for companies to make all preparations by March 2019.”

It added: “We are confident that during this period significant progress has been made — our message remains the same — with 45 million packs of medicines leaving the UK for Europe and 37 million coming the other way every month. Companies must be as prepared as possible.”

The EMA said it would follow up with all non-respondents to the survey, as well as with the marketing authorisation holders that have batch release, quality control and/or importation sites located in the UK only and that have indicated in the survey that they do not plan to submit changes required before 30 March 2019, as this could lead to supply disruptions.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205163

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
  • Patient Care in Community Practice

    Patient Care in Community Practice

    Patient Care in Community Practice is a unique, practical guide for healthcare professionals or carers. Covers a range of non-medicinal products suitable for use at home.

    £22.00Buy now
  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy 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

Jobs you might like

Newsletter Sign-up

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