EU Market Challenges - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

EU Market Challenges


Pharmaceutical Technology Europe
Volume 23, Issue 10

Securing the supply chain Pharma’s supply chain can be very complex.

Importation of the drug product

As previously discussed, all pharmaceutical products manufactured outside of Europe must be analysed in line with the specification outlined in the product’s MAA upon entry into the EU.

In addition, depending on the composition of the pharmaceutical drug product, importation duties and taxes can vary significantly and add to the overall supply chain cost. By assessing the drug product and the manufacturing processes of the product, it may be possible to apply a specific customs procedure to minimise, or even eradicate, duties payable. For example, we have used this approach for a number of high-value biologic APIs being shipped into Europe by US clients.

Securing the supply chain and ensuring traceability

With the increasing problem of counterfeit, misbranded, adulterated and diverted drugs entering the supply chain, it is essential to ensure full traceability of the drug product by seeking advice on the country specific requirements and then implementing an anti-counterfeiting strategy, such as serialisation or 2D matrix barcodes. For example, it is useful for service providers to be able to apply and verify 2D codes to packs, including on-line verification of 2D code quality (ISO/IEC15415) standard) and content. At our company, we can also receive and/or generate serial numbers and apply these within the code and verify on-line. This includes aggregation to shipper and pallet level, and the management of the data and collation thereof for supply to the client.

Distribution strategies for the drug product

Traditionally, client companies would have their drug product manufactured at a CMO and then the finished goods would be shipped to a wholesaler for storage and distribution. To mitigate risk, cost and shorten the supply chain, many client companies are now using CMOs that provide third party logistics services to reach their target market end users.

When deciding upon a distribution strategy, the CMO, in conjunction with the client company, must conduct a distribution risk assessment that considers factors such as product value, transit times to target markets and temperature requirements. Results from the risk assessment should then be written into the distribution instructions to ensure consistency and repeatability in all activities for every product dispatched.

To ensure all drug products reach the end user in optimum condition, the CMO should conduct a full validation of shipping and packaging configurations. For example, our validation and logistics teams work with the client company, the packaging supplier and distribution partners to design a configuration bespoke to the drug product being shipped. We also develop and execute a full validation programme to ensure the solution is fit for purpose. This can be extended to include route qualification where ‘dummy’ shipments can be made to test the performance of the system in transit.

Additionally, it is helpful to find a service provider that can identify paperwork requirements in relation to import, export and customs documentation early in the project to ensure there will be no delays at shipment.

Finally, one of the most important aspects of successfully launching a drug product onto the European marketplace is, quite simply, good project management. Having a detailed, realistic project plan and an experienced and dedicated product supply manager are the keys to success. 


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
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Source: Pharmaceutical Technology Europe,
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