With the toughest requirements, continued business success depends on proactive regulatory planning.
Because of their unique role in the supply chain, parallel importers have perhaps the most challenging set of requirements under the European Union’s Falsified Medicines Directive: part pharmaceutical marketing authorisation holder (MAH), part wholesale distributor, part pharmacy dispenser. Their ability to meet this unique set of mandates will be a critical factor in their business success going forward.
The complexity of their challenge will depend on who they buy from – original manufacturer or other – but overall, there are five main processes that parallel importers operating under EU FMD will need to master:
- Scan and verify the product identifier – typically against a national system – for the source product to satisfy the verification requirement.
- Provide a status update, reporting a decommission of the source product, generally against the national system.
- Serialise their product.
- Report their product’s master data to the EU hub.
- Report product pack data to the EU hub.
To accomplish all of this, parallel importers will need to establish connections to three separate entities: the EU hub; national systems; and CMOs and line management systems.
There is an initial belief in the industry that, given the significant challenges that parallel importers face, there will be consolidation. Starting preparations well in advance – and choosing a proven solution provider that can facilitate connections and help guide the way – will be critical parts of minimising business risk under this new regulatory landscape.