The steps to commercialisation readiness are complex, multi-faceted and often left too late in the launch strategy of a pharmaceutical product. This can be particularly problematic in Europe where the diversity of national legislation can make supply chain logistics very challenging. Among the issues faced, particularly for companies outside the EU are defining the product’s logistics, identifying stakeholders who will be involved in the supply chain in Europe, and ensuring that all these individuals are ready to assume their roles soon after the product’s approval (Marketing Authorisation) with the relevant Licences and Quality Technical agreements in place.
Depending on the complexity of the storage and transportation conditions of the product, and the number of stakeholders envisaged for the supply chain, experience shows that preparing all these steps can take up to two years for quality assurance, commercial and supply chain departments. And, while the European Union has harmonised wholesale distribution regulations and introduced good manufacturing and good distribution practices in the pharmaceutical legislation (Directive 2001/83/EC and Directive 2003/94/EC and Guidelines 2013/C 343/01, respectively), which have helped patients to access medicines faster, there are still different post-approval requirements in each EU Member State, and also in the United Kingdom and Switzerland.
Among these differences, the importation, distribution and release of medicines in the EU, UK and Switzerland are still country specific requiring national authorisations to permit these activities. Moreover, in our experience, getting the necessary licences to ensure an efficient supply chain in all targeted territories requires significant preparation.
