GBA Laboratory Group to Hold Presentation at CPhI 2016 in Barcelona: EU-Import from Non-EU-Countries, Our Concept and Our Solutions to this Challenge
In a second presentation, also as part of the Insight Briefings at the CPhI 2016 in Barcelona, the GBA Laboratory Group’s Pharmaceutical Division will explain some of the special aspects of the European pharmaceutical market. Marco Zeller, a representative from our location in Neu-Ulm (Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG) will present potential solutions for how business from non-EU countries can tap into the European pharmaceutical market.
The European Union, which currently has 28 member states, is still a growing market for the sales of pharmaceuticals. Europe accounts for 25% of the worldwide pharmaceutical sales revenue, and yet the market continues to grow (approx. +4% in 2015). Due to the increasingly aging demographic structure, rising costs in healthcare services, and combined with high quality standards, the healthcare system is increasingly being put under pressure. Pharmaceutical companies from outside the EU (e.g. India, China, USA) have been increasingly observing this situation and in the meantime they have started targeting this market commercially. Often, these non-EU companies enter the market through a selected EU member state. At the moment, Germany, the Netherlands, France, and the UK are the preferred countries for this. The expansion to further EU countries ensues progressively after being granted authorization and building up the marketing and sales organization. Due to the complex authorization procedures and regulatory requirements in the EU, companies from non-EU countries often are stretched to the limits of their capabilities.
Our pharmaceutical division’s locations in Neu-Ulm (Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG), Gräfelfing, and Martinsried (LPU Labor für Pharma- und Umweltanalytik GmbH) offer one-stop shopping for all your analytical needs: comprehensive consulting, analytical and mi-crobiological analyses, complete registration services, and QP services for market authorization.
Depending on the market entry plan and the product, the GBA Laboratory Group provides you with competent and flexible support with both the centralized and decentralized authorization proce-dures and compiles all of the necessary documentation (e.g. eCTD). Following a gap analysis (due diligence), any potential gaps (e.g. validation, stability studies, establishing reference standards, Q3D risk assessment) will be identified, evaluated, and if necessary, closed.
When the authorization is granted and available, a Qualified Person (QP) from the GBA Laboratory Group conducts the qualification of the entire supply chain. If necessary, this includes auditing the production facilities of the active ingredients or pharmaceutical products, even in India, China, the USA, etc., as well as the transportation routes, packaging facilities, storage and distribution centers, and also checking their conformity with the authorization documentation and the pharmacovigilance system being used. The complexity of the supply chain determines the contractual regulations and the clearance of the pharmaceutical responsibilities that are necessary before PHYTOS, as a GMP-certified establishment with a manufacturing authorization, is able to released the product (whether a medicinal product for human use or an investigational product) for market authorization according to § 13 par. 1 of the German Medicinal Products Act (AMG). As further services, PHYTOS offers analytical method transfers, analytical and microbiological testing, importing pharmaceutical and investigational medicinal products to the EU according to § 72 par. 1 of the German Medicinal Products Act (AMG), as well as the usage of pharmaceutical storage facilities compliant with GMP.
With competent project managers, long-term experience in the analytical field and with authoriza-tion procedures, as well as a wide-ranging analytical portfolio, the GBA Laboratory Group is the competent partner that can reliably accompany you through the entire process, from the application to the authorization and bringing your product on the market.
Meet us in person at the CPhI 2016 in Barcelona: Wednesday, October 5th, 2016 (4:30 – 5:15 p.m.), Theater One