Bridge to Europe

Delivery of medicines even before the actual market authorisation is no problem at all with named patient supply service. Together with an experienced specialist, Arvato fulfils the legal requirements and facilitates strictly regulated delivery to patients who have already exhausted other treatment options. Arvato provides consolidated management of all processes, and ensures uniform adherence to the highest quality standards. Arvato also performs the mandated checking of addressees and resolves all customs issues. These services are available for both ambient products and refrigerated products. The requirements for storage and handling of narcotics are also observed.

Arvato supports pharmaceutical companies even before product launch, while Investigational Medicinal Products (IMPs) are passing through the final phases of the clinical studies – from the submission of the clinical trial application to competent authorities to the provision of scientific advice and the development of Certified Medical Education (CME). Naturally, Arvato also handles shipping in Phase IV and provides supplementary concepts for marketing your products. Trained personnel in the Arvato Service Centre also assist with patient recruiting and patient service.

Temperature-managed transport is essential for many medicines and medicinal products. However, many freight carriers only offer national cold-chain transport. Often, only passively cooled transport is available for international freight. Arvato provides an advantageous alternative. Using a direct connection, Harsewinkel feeds daily cold-chain shipments into the network of a local refrigerated carrier, where they are forwarded with active cooling. Delivery to Italy takes 48 to 72 hours (including delivery time) – approximately 24 hours longer than with passively cooled transport. On the other hand, there are savings of more than 20 percent due to lower cost of picking, optimised cardboard packaging and the elimination from the process of expensive insulated boxes. In addition to this, Arvato also guarantees GDP-compliant shipping.

The European transport market exhibits a wide range of variation in terms of delivery deadlines, reliability, cold-chain services and – of course – costs. With access to more than 100 associated carriers, our carrier-independent transport management system (TMS) offers you flexible international transport options, by road, track, air and sea. At the same time, you will be benefiting from the buying power of a large logistics company.

Our TMS allows us to find the most suitable and cost-efficient carrier for any shipment, any time. Be it a package, transport for actively cooled goods, courier delivery or a whole range of products – leave the control tower function to us. Our TMS gives you an overview of all your goods’ movements at a glance. We will only provide you with one monthly consolidated invoice covering all transport. This reduces transport and administration costs.

With its proactive troubleshooting function, our flexible transport management also gives you the flexibility to react in the best possible way to unforeseen situations and to facilitate a timely delivery. We build on the ‘best-in-class’ principle to organise a heterogeneous European transport environment for our clients.

Seamless track & trace processes ensure that everything is adequately controlled and reported throughout the whole shipping cycle. This allows us to pinpoint individual shipments at any given time on demand, or to determine whether a product has been or will be delivered to the consignee within the specified deadline – in a carrier-independent and cross-border manner.

Implementing the Falsified Medicines Directive (FMD) with Arvato

The serialization of prescription medicines is being made mandatory in the EU from February 9, 2019 to prevent counterfeit drugs from entering the legal supply chain. All affected medicines that will be put into circulation from this key date onwards must carry a so-called unique identifier (2D data matrix code incl. serial number) on the folding box, which must, in addition, be sealed with an anti-tampering device. To produce millions of randomised, alphanumeric serial numbers, apply them to the drugs packaging and include the data when tracking goods movements will require special machines, powerful IT systems and intelligent processes. Arvato can offer both the necessary hardware and suitable software solutions and processes to enable the distribution of medicines in line with the FMD requirements, thereby facilitating end-to-end verification. 

Arvato offers the ideal logistics infrastructure for temperature-controlled warehousing and transporting thermosensitive pharmaceutical and medical products. Depending on your needs,  we can store products at -70 ºC, -20 °C, +15 to +25 °C or +2 to +8 °C. A range of ingenious monitoring systems ensures that everything meets the necessary legal conditions and manufacturer requirements.

Depending on your individual requirements, products can be actively cooled during transport and shipped by selected refrigerated carriers, or passively cooled in specially developed, validated transport packaging. Products are dispatched in compliance with GDP guidelines. Client orders are packed in designated picking areas in compliance with the most stringent quality standards before being released for shipment. We can guarantee a seamless maintenance of defined temperature ranges from the moment goods arrive in one of our distribution centres to the moment a shipment is received by the end customer. Here at Arvato, we do not depend on specific subcontractors for our supply of passive cooling systems or transport services when it comes to designing solutions for our clients. This flexibility ensures that we can always find the best possible solutions for individual clients’ needs.

Seamless track & trace processes throughout the whole shipping cycle allow us to determine whether a product has been or will be delivered to the consignee within the specified deadline.

We also provide smoothly integrated solutions for products that are subject to the risk management process due to regulatory requirements regarding prescription and delivery. We manage all processes and bring them into line with the respective national guidelines. In addition to complete traceability along the entire distribution channel, we also need to ensure that products are only sent out to previously registered persons, for example, as only specially trained medical practitioners and staff members are permitted to prescribe or administer this medication. Queries stored in the system facilitate the exclusion of patient groups for whom the risk of side effects is too great. All the data required for the comparison is stored in databases at both the customer’s and Arvato’s premises. Hospitals provide the patient data in anonymised form to ensure optimum compliance with data protection regulations.

Time is of the essence in medical emergencies. Accordingly, Arvato offers its customers emergency deliveries anywhere in the world. An emergency number is available around the clock for deliveries that cannot wait. Specially trained Arvato personnel process the orders and ship the medicine. Of course, temperature management is used for those deliveries that require it, and the strict quality standards for pharmaceutical products and medical technology are observed. Arvato ships via a proven network of couriers, who convey the shipment as quickly as possible to where it’s needed.

Not all delivery routes have a network of refrigerated carriers. As an alternative, Arvato offers its customers passively cooled transport in insulated boxes. The boxes have been specially developed and validated for refrigerated transport. Packing processes adapted to the season ensure that, regardless of the outdoor temperature, the products are transported within the specified temperature ranges and retain this temperature for up to 72 hours. As a result, deliveries around the world arrive on time. Upon request, Arvato will also integrate the customer’s customised boxes into the distribution processes. For air freight shipments, there is also the option of using special Envirotainer transport containers.

Arvato’s central warehouse offers the necessary flexibility for reduced stock under the official licence related to packing, repacking, and labelling medicinal products (guidelines 2001/83/EC). Products are stored in a country-neutral condition, and just before shipment are provided with country-specific labels (e.g. Bollini) and package inserts by specially trained personnel in a strictly isolated, temperature and access-controlled area. 

Pharmaceutical companies benefit from the synchronisation of the postponement solutions with existing processes in the areas of logistics, sales, production or transport. Arvato´s serialisation solutions are also available under the Falisified Medicines Directive.

By combining serialisation and late state finishing in the warehouse, larger, optimized batches can be produced and the number of different packages for different countries reduced drastically, thus reducing the costs of keeping large volumes of various packaging materials on stock. At the same time Arvato serves a high fluctuation. 

Of course we also help medical technology manufacturers to increase the flexibility of their stock, reduce costs, and react more quickly to demands made by the market or their clients. This includes, for example, intelligent kitting or print-on-demand solutions for information accompanying each product such as instruction manuals. 

Arvato serves various sales channels from its warehouses in order to ship medical products to: wholesalers, hospitals, pharmacies, doctors, laboratories and patients. We provide optimal support for manufacturers’ multi-channel strategies, shipping goods from one warehouse which facilitates the creation of standardised structures, a higher level of transparency, optimised processes and stock and reduces costs.

Arvato’s central warehouse offers the necessary flexibility for reduced stock under the official licence related to packing, repacking, and labelling medicinal products (guidelines 2001/83/EC). Products are stored in a country-neutral condition, and just before shipment are provided with country-specific labels (e.g. Bollini) and package inserts by specially trained personnel in a strictly isolated, temperature and access-controlled area. 

Pharmaceutical companies benefit from the synchronisation of the postponement solutions with existing processes in the areas of logistics, sales, production or transport. Arvato´s serialisation solutions are also available under the Falisified Medicines Directive.

By combining serialisation and late state finishing in the warehouse, larger, optimized batches can be produced and the number of different packages for different countries reduced drastically, thus reducing the costs of keeping large volumes of various packaging materials on stock. At the same time Arvato serves a high fluctuation. 

Of course we also help medical technology manufacturers to increase the flexibility of their stock, reduce costs, and react more quickly to demands made by the market or their clients. This includes, for example, intelligent kitting or print-on-demand solutions for information accompanying each product such as instruction manuals. 

Arvato serves various sales channels from its warehouses in order to ship medical products to: wholesalers, hospitals, pharmacies, doctors, laboratories and patients. We provide optimal support for manufacturers’ multi-channel strategies, shipping goods from one warehouse which facilitates the creation of standardised structures, a higher level of transparency, optimised processes and stock and reduces costs.