Store-All have a wholesale distribution authorisation in accordance with Directive 2001/83/EC. However, today’s distribution network for medicinal products is increasingly complex and involves many players who are not necessarily wholesale distributors as referred to in that Directive and therefore the falsified medicines directive emerged.
Compliance is reviewed on a regular basis and especially prior to initiation of a new storage contract. Relevant licenses are reviewed and updated accordingly. Storage of API will also require an update to the clients manufacturing license. If the API is being imported from outside the EU, the client will be required to be registered with the IMB as per DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products
Key facets of our ISO 9001:2015 Quality Systems include: