TwitterLinkedin

Contact Us

  • Biopharma Excellence
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Integrated Product Development
            • Market Access
            • Scientific Advice
            • Statistics and Data Sciences
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Scientific Advice
            • Statistics and Data Sciences
          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistics and Data Sciences
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • ICSR (Individual Safety Case Report) Management
            • Literature Monitoring & Screening
            • Pharmacovigilance Quality & Compliance
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • MedTech Services
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • COVID-19 Support
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Post-Brexit Regulatory Support
            • Statistics and Data Sciences
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Career Opportunities
  • Training
Home > News & Events > BREXIT Updates > Brexit Supply Chain Risk – 5 Considerations

Brexit Supply Chain Risk – 5 Considerations

On 2nd May 2018, minutes were published of an Industry Stakeholder meeting on Brexit and operation of the centralized procedure for human medicinal products that was held at European Medicines Agency on 23rd March 2018.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2018/03/event_detail_001615.jsp&mid=WC0b01ac058004d5c3

The purpose of this meeting was to update European Union trade associations on the Agency’s Brexit preparedness activities.

A couple of days prior to this meeting, the draft text of the Withdrawal agreement of the UK and Northern Ireland from the EU was published. The withdrawal agreements needs to ratified on both sides. The “Transition period”, until 31st December 2020 (inclusive) is part of the Withdrawal agreement.

Despite this “Transition Period” it was stressed at the Industry Stake holder meeting that this Withdrawal agreement is still not agreed upon (“nothing is agreed before everything is agreed”) and not yet ratified by the concerned parties. In terms of governance, as of 30 March 2019, the United Kingdom will no longer take part in the decision making of EU institutions and bodies, nor will it have a role as a leading authority, meaning that the UK will not have a role as rapporteur or reference Member State.

It was very clearly recommended to prepare on the scenario of a “hard Brexit”. It was stated:-

“In view of the considerable uncertainties, industry should not rely on the “transition period”. Even if there is commitment to reaching an agreement on the UK’s orderly withdrawal, this should not dispense from ensuring ‘preparedness’. The Withdrawal agreement needs to be ratified by the UK and the EU and this is only expected early in 2019. Therefore preparedness is a matter of today.”

So with this advice from the EMA, it is timely to look in detail at your supply chain risks. Here are some elements to consider:-

Review your Supply Chain Maps and Staff Appointment:

After Brexit, UK entities will be no longer permitted to hold EU Market Authorisation or to be sponsors of orphan designations. Companies need to be actively seeking out alternative arrangements for MAHs and MAAs.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_001891.jsp&mid=WC0b01ac0580cb2e5b

Therefore, companies will need to look at roles currently carried out by UK entities and determine the most appropriate changes to be made. This could change the supply chain dramatically and trigger review of licenses such as Manufacturer’s / Importers Authorisations and Wholesale Distributor Authorisations. Relocation or recruitment plans for roles such as the QP role should be put in place as your QPs must be EU Residents.

Risk to your Customers:

Companies need to have contingency plans in place to ensure delivery of your end product to your customers. There is no guarantee that border procedures will operate smoothly immediately after Brexit, and companies will need a contingency plan for continuity of supply in case systems fail. One scenario to consider, for example, is that there could be delays of up to two days between the UK and EU because of the need for document checks. To counteract that, companies could consider setting up a supply cache and asking customers to take extra stock in advance. It has been reported that some pharma companies have already planned for this. https://www.thetimes.co.uk/article/drug-firms-build-brexit-stockpile-pq0gw8sb2

The pharmaceutical companies most at risk are those involved in medicines that require certainty in supply chain timelines (for example cell and gene therapies). Companies such as this need to address this risk carefully.

Risk from your suppliers:

Consider your suppliers. Do your suppliers have contingency plans for Brexit? Do your QTAs or contracts with your suppliers need to be updated to ensure robust supply chain through the Brexit process? As part of your contingency planning, look at your high risk suppliers.

Communication Strategy:

No matter what the actual outcome, Brexit is going to cause disruptions across the supply chain which is bound to have a knock on effect throughout. Ensure all your customers and suppliers throughout the supply chain are in the loop. A robust communication strategy will be needed.

Review processes and systems for data capture:

Based on the UK Government’s current commitment, it is likely that Brexit will establish a customs border between the UK and the EU at some point. This may lead to the introduction of new customs processes, tariffs and import taxes. With this it is inevitable that new data will need to be captured, and communicated. In light of this, companies can be cleaning their current data and preparing their systems to collect new data fields (eg. for export declarations versus an Intrastat declaration). It would be prudent for companies to review options for data storage outside of the UK in case geographical restrictions appear.

We, at PharmaLex, are ready to help you prepare. Have you considered all scenarios? Are your contingency plans in place for supply chain interruptions? Please contact us to discuss.

Related posts
Resilience of Pharma Supply Chains and the Impact of Covid-19 Pandemic
Resilience of Pharma Supply Chains and the Impact of Covid-19 Pandemic
17th May 2021
Contamination Control
Contamination Control
8th April 2021
Rules on Ownership of Medicinal Product stock distributed in Great Britain
Rules on Ownership of Medicinal Product stock distributed in Great Britain
7th April 2021
GET SMART: reliable analytical results & continuous regulatory compliance!
GET SMART: reliable analytical results & continuous regulatory compliance!
30th March 2021
Challenges of Advanced Therapy Medicinal Products (ATMPs)
Challenges of Advanced Therapy Medicinal Products (ATMPs)
16th March 2021
Supporting M&A in the pharmaceutical / biopharmaceutical industry
Supporting M&A in the pharmaceutical / biopharmaceutical industry
11th February 2021
Search
Upcoming Webinars

June 28th, 2022

eCTD in Australia: key steps to start a successful submission

08:30 am CET / 4:30 pm AEST

June 28th, 2022

An Introduction to Bayesian adaptive methods in clinical trials

04:00 PM CET

June 30th, 2022

Transforming the drug development process with an integrated strategy

03:00 PM CET

Categories
  • All News
  • Webinars
  • Events
Archive
Biopharma Excellence Website Image

PharmaLex Brings You Biopharma Excellence

Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.

Visit Website
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
PharmaLexGLOBALPharmaLex@PharmaLexGLOBAL·
24 Jun

Milena Shuytsova-Mircheva and Lisa Pascoe latest blog here https://www.pharmalex.com/sponsors-gear-up-for-a-smoother-process-with-ctis-but-must-first-overcome-key-hurdles/ discusses the benefit of the Clinical Trial Information System (CTIS).

💡 Interested in CTIS? Take the Phlexglobal survey to evaluate your preparation https://www.phlexglobal.com/ctis-survey

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • Provided honest feedback and collaborative working solutions to obstacles

    South Korea based medium sized company
    Manager
PharmaLex
©2022 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit LogoSGS Logo

Suspicious Emails

We are aware of a number of suspicious emails about recruitment in circulation purporting to be from PharmaLex. Emails sent by PharmaLex will originate from @pharmalex.com. Should you receive an email and are unsure as to its validity, please report it to contact@pharmalex.com.

Many thanks for your understanding.

The PharmaLex Team

    Please DO NOT send us event/conference information.
    We will not respond and these will be deleted immediately.






    Select your state:

    .
    If you do not wish to receive any communication from us, you may unsubscribe at any time.

    #AskTheExpert #TogetherBEYONDCOVID19





      Select your state:

      .
      You can unsubscribe at any time at data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      #TogetherBEYONDCOVID19

      We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for