Supply-chain controls updated as the FMD became applicable
Ergopharm has completed a review of its packaging and supply-chain controls following the application of the European Union's Falsified Medicines Directive on 2 January 2013. The review confirms that our export packaging and distribution processes are being prepared to support the safety features the Directive introduces.
Directive 2011/62/EU, published on 1 July 2011 and applicable from 2 January 2013, amends the EU medicines code to strengthen the supply chain against falsified medicines. It establishes the framework for two safety features to be placed on the packaging of certain medicinal products: a unique identifier carried in a machine-readable code, and an anti-tampering device. The Directive also tightens obligations across the distribution chain, including on the sourcing of active substances and on wholesale distribution. The detailed technical rules for the safety features are to follow in a delegated act; until that act and its own application date are settled, manufacturers are working to be ready rather than to a fixed operational deadline.
“Our aim is straightforward: to prepare Ergopharm's own packaging and records now, so that when the Directive's safety features become operational our export batches are ready without disruption.”
As a manufacturer based in Vadodara producing for export, Ergopharm treats these developments as a design input for its packaging and quality systems. Our approach is to align our own processes to the direction the Directive sets, so that products destined for markets that adopt these controls can carry the required features without disruption. This work sits within our existing pharmaceutical quality system and is managed through change control, with any modifications to artwork, packaging lines and records handled as documented, qualified changes.
In practice, the review has focused on three areas of our own operation. First, packaging design and serialisation readiness: preparing our lines and label artwork to accommodate a unique identifier in a two-dimensional data-matrix format and the data elements needed to identify each pack. Second, anti-tampering: confirming that tamper-evident features can be applied and verified as part of the packaging record for each batch. Third, supply-chain documentation: reviewing how batch identity, dispatch records and Certificates of Analysis flow with the goods so that traceability is maintained from our site to the point of export.
No specific national marketing approval is claimed by this notice, and the figures and timelines described here are for planning purposes. The technical detail of the safety features remains subject to the forthcoming delegated regulation, and Ergopharm will update its packaging specifications and standard operating procedures once those requirements are finalised. Ergopharm will continue to manufacture and release product under its GMP quality system, with Qualified Person release and full batch documentation, throughout this transition.
Key facts
- Instrument
- Directive 2011/62/EU (Falsified Medicines Directive)
- Applicable from
- 2 January 2013 (published 1 July 2011)
- Two safety features
- Unique identifier in a 2D data-matrix + anti-tampering device
- Technical detail
- To be set by a forthcoming delegated regulation
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.