Tag: Pharmaceutical Logistics

The Potential Impact of Brexit to Your Supply Chain

The Potential Impact of Brexit to Your Supply Chain

Following on from the very recent vote for Britain to leave the EU, here are our top tips to consider for your supply chain.

  1. Customs Clearance – The re-introduction of UK Customs Clearance is a possibility. We would recommend that you run a health check over your Tariff Codes, ensuring that they are up to date and reflect the commodity you are importing or exporting.
  2. Customs Regimes – If you are operating under any Customs Regimes, now would be a good time to explore what impact the EU vote might have. Are your regimes still valid or do you need to implement new ones? Make sure you pause to understand the impact before you make any changes.
  3. UK Border Enforcement – The potential enforcement of the UK border may well impact transit times through ports and airports. Stay up-to-date with developments to ensure that you limit any effect this may have on your Supply Chain.
  4. Time and Temperature Shipments – For Time and Temperature Sensitive Products, including pharmaceutical shipments, we would strongly recommend you conduct a robust risk assessment for both the security and potential temperature impacts on your products. Longer transit times could mean heightened risk.
  5. Collaboration – Finally, now is the time to ensure that you are communicating and collaborating with all of your supply chain stakeholders – the more dialogue and knowledge you have, the more robust the chain will be.

Change is never easy and the uncertainty of what the future may look like is an added difficulty. Unification of key stakeholders, and a cohesive project plan to mitigate risk and adapt to new legislative and regulatory compliance is critical to securing a safe and effective supply chain.

ASC Associates provide a range of services which could help you navigate the uncertainty that lies ahead. Why not contact us to find out more.

SMI Clinical Trials Conference 2016


Amy Shortman, our Chief Executive Officer, spoke at the Clinical Trials Logistics Conference in May. Here she describes how the conference went, and the benefit of attending such a conference for both ASC Associates and other companies working in this sector.

On a rainy day in Kensington, London, SMI held its 10th Clinical Trials Logistics Conference. It was chaired by Rebecca Jackson, the IVR/IWR Manager for Randomisation & Trials Supply Services at Janssen. Jackson delivered an enigmatic and thought provoking opening presentation explaining how personal experiences of loved one suffering with disease fuelled her passions for research and development of new products.

The day’s agenda was broad, ranging from presentations on Temperature Excursion Management to RTSM or AI; Human versus Machine? However many of the speakers continued the theme set by Jackson’s opening presentation, explaining how their passion for this industry has been sparked by the genuine desire to improve patients’ lives, as one day it could be our family or friend in need of a treatment.

I spoke on ‘Understanding the Impact of the EU GDP Guidelines’. My focus was to explore the impact the MHRA Guidelines for the Short-term Storage of Ambient and Refrigerated products – requirements for a Wholesale Dealers Authorisation (WDA) – had on key stakeholders such as the shipper, 3PL and airline. I presented three case studies using Mundipharma as my shipper, Nippon Express Ltd a 3PL and Virgin Atlantic Cargo, airline.

The results were interesting, as the shippers welcome the changes, which result in its supply chain partners being self-regulated and approved via the licence directly from the MHRA. Although this will never replace due diligence or auditing, it will reduce the level of detail to which the shipper has historically had to audit. For the 3PL and airline, who have been moving pharmaceutical and cool-chain products for years, the WDA will bring formalisation of their processes and proof to their customers of their high quality standards. My message was to embrace these changes as they benefit products and their efficacy, because at the end of the day having medicines that are safe and effective is paramount.

My highlight of the conference was the presentation Terry Madigan, GDP Inspector for MHRA gave. He reaffirmed the MHRA’s stance on the WDA and confirmed that those who are storing refrigerated medicines for human use for any length of time, and CRT (Control Room Temperature or Ambient) for longer than 36hrs, require a WDA. This includes all Logistics providers, Ground Handling Agents and Airlines.

There is still a lot of work to do in the industry, as it is clear from some conversations that there is still uncertainty that the WDA is required by some companies. Maybe it’s denial, but the reality is that compliance is strategically important for any company wishing to work in the distribution of Medicinal Products for human use. Acting sooner rather than later can only be of benefit to your company.

If you are unsure of how this affects your company and would like some training, please contact us.