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November 16th, 2020

BREXIT – your questions answered

BREXIT will soon be upon us and on 31st December 2020 as 2300Hrs, the UK will leave the EU.

Although even at this late stage much remains unclear, one thing we do know is that whichever way this plays out, things are about to change for us all and there is much to do for everyone to be ready for these changes. It will be vital to understand how your sales and supply chains work, and who is responsible for what. For example, will your European suppliers get involved in the export customs process for your orders, and when selling to your European clients, how they will handle the import customs requirements?

With this in mind Pharmafreight has prepared a list of questions and answers, and other things to think about, to help your company prepare for what lies ahead.

Buying or shipping from Europe (imports)

  1. Under which Incoterm do you purchase/use with your supplier(s), e.g. EXW, FCA, or even DAP?

If EXW (for a full list of Incoterms and their definitions see https://en.wikipedia.org/wiki/Incoterms), you are responsible for any customs action required in the origin country, and after BREXIT the UK will become a Third Country, meaning any purchases from the 27 EU Member States will be Exports, requiring some kind of customs action, e.g. customs export entry (C88). If your purchase your orders under FCA or DAP terms, your supplier is responsible for the customs paperwork.

  • If you purchase your orders EXW, have you planned with your freight forwarder or transport company to take care of any customs export declarations or transit paperwork as required?

For movements by Air, a customs export entry would need to be raised before the shipment departs the origin airport, and a customs record would automatically be raised by the UK receiving handling shed, which would then need to be cleared through HMC’s computer system, CHIEF.

For movements by road, a customs export entry and possibly transit paperwork linked to a customs guarantee would need to be raised, to allow your shipment to transit from the origin point through to the UK land border, e.g. Dover Port.

In both instances Pharmafreight can offer local support in origin country to get such paperwork raised, however this will involve speaking to your suppliers at origin, and them giving authorisation for Pharmafreight to talk to Customs on their behalf.

  • What shipping documents will be required to raise export paperwork and clear a shipment through UK Customs (HMRC) upon arrival into the UK?

At a basic level, your supplier will need to have its own EORI number for the export process and provide an invoice which covers the transaction/product to be shipped, e.g. the commercial invoice. Depending on the trade deal the UK obtains other documents may eventually be needed, such as a certificate of origin, however for the moment, only an invoice is required for standard products, not under other regulatory controls, e.g. controlled drugs/animal products.

Your own company will also need its own EORI number (this number is shown on the C88 to HMRC to identify your company as the importer of record (IOR) in the UK, and Pharmafreight will need to hold on file a Direct Representation authority from your company, which authorises it to act on your behalf when talking to HMRC. (If you have not already been asked to complete one of these forms please do get in touch with us.)

  • What if you buy your products on a DAP basis from your EU supplier (delivered through to your door – taxes unpaid)?

In this case your supplier will be organising the transport from its door through to yours. It is their responsibility to organise the customs export process and documentation for the movement, however you would be responsible for the customs clearance in the UK.

For air movements, the shipment would arrive into a UK airport, again at which point a customs record would be created by the airline carrier, and Pharmafreight can clear the shipment through UK Customs in your name, using the shipment’s invoice, and by holding a Direct Representation authority from your company. You should encourage your suppliers to share flight details and copy AWBs with you, so you can alert Pharmafreight to the shipment’s impending arrival into the UK, avoiding possible storage charges at the airport.

For road movements, the shipment would be most likely to arrive at a Short Sea port such as Dover, at which point it can be cleared through UK Customs. HMRC is advising that standard transactions can be cleared away from the border and you have up to six months to raise a customs entry, however for larger companies with multiple transactions, Pharmafreight would encourage customers to have their shipments cleared upon arrival, rather than wait. Again, customers should request truck arrival details for their orders, so when the truck does arrive at Dover, a customs entry is waiting for it, so the truck does not get held up, generating demurrage charges whilst the truck is delayed.

  • What about the payment of customs import duties and VAT?

Following the UK’s departure from, products will no longer be able to move freely between EU Member States in free circulation, and certain import taxes will now become due. The good news is that the vast majority of finished product pharmaceuticals are free from duty (this is still to be confirmed and is dependent on the trade deal which the UK secures with the EU), however if duties are payable e.g. you are importing an API, Pharmafreight would encourage you to open duty deferment account with HMRC (see https://www.gov.uk/guidance/setting-up-an-account-to-defer-duty-payments-when-you-import-goods).

Having such an account allows you to put any duty amounts to be paid against this account, so the shipment will clear UK Customs without an upfront payment to HMRC of the owed amount, which can be paid by you at a later date. VAT can also be put against your deferment account, however HMRC is introducing postponed VAT accounting for next year, which means VAT will no longer be payable immediately upon import, and such amounts can be reconciled via your company’s VAT return process.

If you do not have a customs deferment account, it may be possible to pay HMRC direct using the FAS system, or use Pharmafreight’s own deferment account, which is available for use at extra cost.

  • Will shipments coming from the Republic of Ireland be subject to the same controls?

Yes, a customs export entry will need to be raised in Ireland, and an import entry will be required upon arrival at the UK border, with any duties paid at that time, or placed onto a customs deferment account, and vice versa for shipments travelling into the Republic of Ireland.

If you are involved in shipping to and from Northern Ireland please also be aware of changes afoot for the way we will have to handle shipments to and from there, with some level of declarations required for there too (we would encourage you to sign up to TSS if you deal with Northern Ireland (see https://www.gov.uk/guidance/trader-support-service).

Selling/delivering into Europe (exports)

  • What documents will you need to export products from the UK?

Just like when importing shipments, you will also need an EORI number from HMRC to export shipments. This number is shown on the export declaration form (C88), You will also need to provide Pharmafreight with the commercial/proforma/shipping invoice covering the sale or movement. The invoice should also show the relevant HS tariff code ( see https://www.gov.uk/trade-tariff) which exactly defines what you are shipping, and also makes up part of the export customs entry.

  • What Incoterms do your sell under to your EU customers, or trade under with your European partners?

Again, if you trade using EXW, it is the responsibility of your buyer to take care of the customs export entry – which in theory they would do by using their own freight forwarder or transport company, however in recent times the UK’s MHRA has taken a stance against UK WDA holders selling licensed medicinal products under EXW, preferring FCA (Free Carrier) as that requires the seller to take responsibility for the export customs work, ensuring the licence holder knows where the product is being exported to. 

As part of an export shipment process under FCA and DAP terms Pharmafreight would undertake the customs entry for its customer, as long as it has a Direct Representation form in place from the shipper.

  • How will the customs process differ between movements via road and air?

By Road – over the last two decades, for movements into Europe there has been a remarkable shift from airfreight over to road freight, with the vast majority of EU trade moving on trucks between the UK and the EU Member States. Depending on the destination country, after BREXIT it may be necessary to use the customs road system NCTS (New Computerised Transit System) to raise customs entries and transit paperwork (T1 forms) to cover the moment under the Common Transit Convention (CTC). Such entries must be backed by a transit guarantee, lodged with HMRC, to ensure that if a shipment does not get discharged properly from under its T1, any potential taxes (import duties etc.) are paid to customs, designed to prevent the shipment being fraudulently re-routed to another country and delivered there.

For a charge Pharmafreight can raise all the customs paperwork required for a road movement, as well as provide the transit guarantee for any T documents needed. Its customer will need to sign a guarantee liability form to gain access to use its transit guarantee, taking on the liability for its use.  To avoid potentially high costs to use Pharmafreight’s transit guarantee, clients are encouraged to obtain their own transit guarantee from HMRC (see https://www.gov.uk/guidance/import-and-export-customs-comprehensive-guarantees-ccgs)

By air – in some ways airfreight will be somewhat easier, with an export entry being raised in CHIEF prior to departure of the aircraft, and a customs entry will be needed upon arrival at destination. Again, who conducts these will be dependent on the Incoterm your company sells at.

  1. Will you need a copy of the customs entry for your records?

Just like any shipments you send to Third Countries now, the MHRA and HMRC would expect you to keep appropriate records relating to exports, and a copy of the C88 raised on your behalf should be obtained from Pharmafreight, or the freight agent which undertakes the export entry on your behalf (e.g. under EXW).

March 20th, 2019

Temperature mapping an aircraft – a case study

Purpose

The majority of the pharmaceutical (temperature controlled) supply chain has been well qualified and documented over a number of years within the most common areas, such as warehousing, cold storage and vehicles. However there has been very limited work carried out to fully understand the conditions that are experienced in the cargo holds of aircraft used for the transportation of temperature sensitive pharmaceutical products.

For this reason, Biomap and Pharmafreight decided to partner up and use their respective areas of expertise to undertake the challenging process of mapping an aircraft during a live flight, to understand the temperature profile during flight and any risk areas that were highlighted in the recorded data.

Biomap would offer the resource and expertise for the mapping element, and Pharmafreight would utilise its relationships with the airlines and freight forwarding expertise in preparing pharma consignments for carriage by airfreight.

Sourcing the Right Partner

A number of airlines offering a pharmaceutical service were approached to support the project by allowing access to their aircraft for the mapping exercise.  We knew this would be a complex task in light of the tight security around accessing aircraft and freight during the loading process at the airport.  We also wanted to be able to share the data with industry by presenting the results at various professional discussion forums and seminars, whatever the data gathered showed, good or bad.

Etihad Airways were one of the carriers approached, as we knew that in addition to its core activity of passenger transportation, they also operated a significant cargo section perfect for the joint study.  Etihad were incredibly supportive of the project scope from the start, as it had been looking to develop the transportation side of its cargo operations for pharmaceutical products, and there would be huge value in being able to demonstrate the temperature performance of a cargo hold of their aircraft during flight.

Etihad Airways is the second-largest airline of the United Arab Emirates, and commenced operations in November 2003 with its head office in Khalifa City, Abu Dhabi, near Abu Dhabi International Airport.  It operates a fleet of 120 narrow and wide-body Airbus and Boeing aircraft within the Middle East, Europe, Asia, North America, Canada and Australia. This equates to more than 1,000 flights per week to over 110 passenger and cargo destinations.

The Process

Biomap and Pharmafreight proposed a solution and Etihad kindly agreed to offer an aircraft for the project, and a date was agreed.  Biomap raised a comprehensive protocol and plan documenting the suggested approach to map a Boeing B777, one of the most commonly used aircrafts used for this type of freight.   From the outset the project reminded us how quickly things can change with airfreight when at the last minute, the operating aircraft was changed from a B777 to an Airbus A330-200.  Not an ideal situation as the protocol and plans were designed for the B777 configuration.  This meant a speedy redesign of the protocol and logger placement requiring approval before we could commence.  This was achieved and the mapping process continued with the new protocol.

The initial exercise was conducted during winter at Manchester Airport – United Kingdom, to Abu Dhabi International Airport – United Arab Emirates, where it is generally quite warm all year around, with an approximate flight time of seven hours. The mapping study would determine if any hot and cold spots would occur during the exercise, and look to highlight any temperature issues experienced during flight.

The Result

A full temperature mapping exercise was conducted with data loggers positioned throughout the cargo hold (see fig.1) where the pharmaceutical products were transported, and a number of temperature excursions were recorded between the departure and arrival times.

Biomap and Pharmafreight staff supported the installation at Manchester Airport, while Etihad personnel located and retrieved the data loggers at Abu Dhabi Airport, once the flight was complete. These were then handed back to Biomap’s offices in London for processing and data assessment.

Once this was complete, full reports for the hold conditions during flight were produced. This included full graphical and summary data, as well as detailed analysis of the temperature performance and full reports were then submitted for review.

The Next Steps

As the initial aircraft for the mapping exercise had changed on the day of the flight, the project will be repeated with a B777 as originally planned. This particular aircraft is the most commonly used by the Etihad fleet for transporting pharmaceutical products.

September 12th, 2017

Pharmaceutical temperature controlled GDP warehousing MHRA approved

Pharma warehouse

Pharmaceutical temperature controlled GDP warehousing MHRA approved

NEWS: Pharmaceutical temperature controlled GDP neutral warehousing, MHRA approved. Pharmafreight UK holds its own MHRA Wholesale Dealer’s Authorisation (WDA), allowing it to store medicines and related products at its warehouse at London Heathrow. The site is fully compliant with the GDP requirements, with its key features as follows:

  • Over 400+ Euro pallet positions available
  • Storage at both +2 to 8’C and +15 to +25’C
  • Smaller LabCold fridges for product pack storage
  • Fully temperature-controlled warehouse
  • Continuous temperature monitoring system in place
  • Storage, pick-and-pack services available
  • CCTV, Police-linked alarm
  • Fire alarm system
  • AEO
  • Short-term contracts available
  • Fully temperature-mapped facilities
  • Audits welcomed
  • Large variety of storage options, including state-of-the-art chilled/temperate facilities.
  • Envirotainer, CSafe etc. loading under controlled conditions

Pharmafreight also offers our dedicated temperature-mapped vans for deliveries throughout the UK and Europe manned by GDP trained drivers.
Our overseas Pharmafreight partners can also offer a variety of GDP-compliant storage solutions, depending on a client’s requirements. Please ask us about these today!

Contact us at info (at) pharmafreight.com or 01784 248636 – Andy Hughes

C Safe containers at Unit 22

Pharmaceutical temperature controlled GDP warehousing MHRA approved

October 3rd, 2016

Pharmafreight AGM – Barcelona 2016

Pharmafreight held its AGM in October in Barcelona this year. The annual meeting of Pharmafreight licensed partners is held one day before the start of the annual CPhI global pharmaceutical meeting place exhibition. This year’s AGM and presentations dealt with the ongoing GDP audit roll-out of all global Pharmafreight partners to a common standard.

2016-10-03-10-50-53

May 12th, 2014

Pharmafreight now holds MHRA licence for its London Heathrow facility

Pharmafreight is pleased to announce it now holds an MHRA Wholesale Dealer’s Authorisation, allowing it to store and transport medicines through its London Heathrow site.

Following a successful application and subsequent audit from the UK’s health regulator, the MHRA (Medicines and Healthcare products Regulatory Agency), Pharmafreight is now one of only a handful of UK freight companies that holds a Wholesale Dealer’s Authorisation (WDA), allowing it to store medicinal and related products at its temperature-controlled facility in Ashford, Middlesex, just outside London Heathrow Airport. The WDA also confirms Pharmafreight complies with the new Good Distribution Practice (GDP) Guidelines, designed to ensure that patient safety is upmost in a company’s mind, and that the efficacy of a drug is not affected whilst in a licence holders’ care.

Pharmafreight started working in the pharmaceutical forwarding industry back in the 1990’s through its parent company, Mach II Shipping. At that time it was relatively unheard of for a freight forwarder to understand and work to the regulations that pharmaceutical companies had to abide by. Having identified a gap in the market for a specialist freight forwarder dealing only in pharmaceuticals, the Pharmafreight division and brand was established, recruiting like-minded overseas freight companies into its own network, all designed to work to GDP.

During the European Commission’s consultation period last year on the new GDP Guidelines, it was initially suggested that any company in the supply chain holding product for more than 24 hours would need to have a WDA, which would have meant that any airline, transport or warehouse company could potentially need a licence. However this was eventually watered down so that a licence holder must only “minimise” the amount of time that its product is in an unlicensed facility. Despite this Pharmafreight decided that it still wanted to demonstrate to the pharmaceutical industry its aim to be associated with quality in the supply chain, and applied for a WDA licence anyway. Its successful application means that Pharmafreight can now store medicines at its facility for longer than a day, in accordance with GDP, and in the right temperature and quality conditions.

Andy Hughes, Commercial Director at Pharmafreight, said: “We are very pleased to be only one of a handful of independent freight forwarding companies that holds a Wholesale Dealer’s Authorisation in the UK. Pharma companies using our services can take some comfort that we are working to exactly the same legal requirements they are, fully compliant in GDP. And we apply these standards whether we are storing a product on a customer’s behalf, or indeed transporting a shipment halfway across the world.”

For further information about Pharmafreight and its services, please visit www.pharmafreight.com or e-mail info@ pharmafreight.com

March 10th, 2014

Pharmafreight appoints new partner in Canada

Pharmafreight is very pleased to announce the appointment of Geo Express International as its latest licensed partner, looking after Canada for the Group.

Pharmafreight has known Geo Express for a while now, and it has a good reputation in the clinical trial logistics market. It has been in operation since 1979 and specialises in several niche markets, including Health Sciences. Its specific offerings include:

– 24/7/365 door to door transportation of time and temperature sensitive material worldwide
– Clinical Trial Logistics of IMP, ancillary supplies and biological samples for safety/efficacy testing as well as for PK, PG, PD and biomarker assessments
– CTM depot services for drug storage and distribution (ambient, refrigerated and frozen)
– Cold Chain Management including packaging validation and provision/replenishment of refrigerants, packaging, and data loggers
– Health Canada Classified Distributor under HPFB Inspectorate GMP guidelines
– Health Canada Establishment License for the importation and distribution of Pharmaceuticals, NPNs, and Medical devices
– Canada Customs (CBSA) Bonded Warehouse License for temp-controlled imports specific to the Health Sciences industry

For further information please visit www.geoexpressinternational.com/health-services.html

If you have any requests for Canada please e-mail info@pharmafreight.com at this time.

February 10th, 2014

Pharmafreight appoints new partner for Denmark, Finland and Sweden

Pharmafreight is very pleased to announce the appointment of a new partner to look after Denmark, Finland and Sweden.

Following a successful onsite visit to its operation in Copenhagen, Denmark, Pharmafreight has appointed the Finnish CHS Group – incorporating the AirLog Group in Denmark and Sweden – as its new partner for the region. The company has already been working in the clinical trial sector for several years now, providing temperature-controlled packaging and data loggers for its clients, as well as know-how on how to conduct clinical trials and handle pharmaceutical logistics. The company has completed Pharmafreight’s pre-application process, where all of its operations are audited against the new GDP Guidelines, before being appointed to the network. The company’s staff will now be required to undertake further GDP training via Pharmafreight’s online training centre.

For further information about CHS and AirLog, please visit the country pages on this website, or e-mail info@pharmafreight.com

November 23rd, 2013

Video: The opening of the Lufthansa Cargo Cool Center

November 12th, 2013

Video: New British Airways Constant Climate Facility at LHR

October 29th, 2013

Revised EU GDP guidelines (2013/C 68/01) in various languages