Recipharm anticipates FMD compliance struggles, launches standalone service

By Ben Hargreaves contact

- Last updated on GMT

(Image: iStock/RawPixelLtd)
(Image: iStock/RawPixelLtd)

Related tags: Serialization, serialisation, medicine packaging, FMD, DSCSA

Recipharm has revealed that it will be offering a standalone serialization service to companies that have not yet prepared for the upcoming FMD deadline.

The new service will be able to add 2D codes, human readable text and tamper evidence to already packaged medicines.

A spokesperson for Recipharm explained why this could appeal to companies: “The service is designed to fill the gap between current packaging and compliance with the EU FMD. The project scope could be to only add serialization data to packages or it could be wider artwork adaptations as part of secondary packaging requirements. Aggregation will also be offered if requested.”

In terms of how long this will process will add to customers packaging timeframe, the spokesperson replied: “From a regulatory point of view it is relatively straight forward to implement this service if you are only adding serialization date to existing packs and as such, it will not have a big impact on time scales. However, if customers also require secondary packaging support this will take longer as we will need to obtain regulatory approval. From a technical and capacity point of view this will depend on individual customer requirements and volumes.”

It is anticipated that the standalone service will be used by those companies that do not yet have an agreement in place to manage the serialization process, as a temporary measure. However, Recipharm anticipates that this could lead to lasting partnerships with companies.

The spokesperson explained, “We work hard to develop relationships with our customers so, of course, our goal is to have long-term supply agreements in place. We're confident our standalone serialization service will allow our team to demonstrate the added value the Recipharm team can bring to our customer operations.”

The company stated that companies employing its services have resulted in over 1.3m serialized and aggregated packs being delivered to areas in the Middle East and East Asia, including China, South Korea, Turkey and Saudi Arabia. In addition, the company has also exported 500,000 packs to the US – where the Drug Supply Chain Security Act (DSCSA) requires track and trace capabilities.

Expanding capabilities

Ahead of both the FMD and Brexit deadline, Recipharm has expanded rapidly to accommodate the increase in business and to broaden its services. This has meant building an entirely new workforce to deal with Brexit repercussions​.

It also seen the firm enlarge its roster of facilities, by acquiring Sanofi’s CMO site​ in the UK.

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