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Policy & Compliance Vaccine transport challenge


With the development of COVID-19 vaccines globally, it is imperative that their distribution is managed efficiently. BIFA Members hoping to offer their services should start planning now to ensure that specific transport requirements can be met


www.bifa.org


Shipping a coronavirus vaccine around the world will be the “largest transport challenge ever”, according to the airline industry. The International Air Transport Association (IATA) has estimated that the equivalent of 8,000 Boeing 747s will be required based on the assumption that only one dose per person is needed. Not all planes will be suitable for delivering


vaccines as they need a typical temperature range of 2 to 8°C for transporting drugs. Some vaccines may require freezing temperatures, which would exclude more aircraft. Just as important is the final mile


delivery/collection. Whilst many freight forwarders will view this as an opportunity, they will need to prepare themselves to adhere to strict guidelines relating to the distribution of medicines and related products.


Regulations Good Distribution Practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the regulator or product specification. In the UK, the Medicines and Healthcare


Products Regulatory Agency (MHRA) authorises and carries out inspections to ensure that manufacturing and distribution sites comply with Good Manufacturing Process (GMP) or GDP. Forwarders should be aware that there are different rules for the transport of ambient and refrigerated medical products; in relation to the latter, in most


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cases the premises will have to be licensed. Guidelines that currently fall under those of the


European Commission are unlikely to change significantly despite the EU Exit. Details can be


found at the following link to the Official Journal of the European Union: https://eur-lex.europa.eu/legalcontent/ EN/TXT/PDF/?uri =CELEX:52015XC0321(01)


Reference guide As expected, it is a weighty document, but necessarily detailed to ensure safeguarding of the product. The other important reference guide is Rules and Guidance for Pharmaceutical Distributors 2017 (The Green Guide) ISBN 9780857112866. Additional useful information can be obtained from the MHRA website at www.gov.uk/guidance/contact-mhra Those already involved in pharmaceutical


distribution will be at an advantage and already operate under the guidelines for the sector. Those wishing to prepare to enter this market should not under-estimate the regulatory and procedural hurdles to be overcome, not least the length of time needed to obtain approval, which is currently up to 90 days.


November 2020


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