Life Sciences Horizons Brochure 2025 - Flipbook - Page 8
7
2025 Horizons Life Sciences and Health Care
Stricter GMP, GDP, and other supply chain rule enforcement in the EU
The supply chain for medicinal products, from
manufacture of a pharmaceutical product to import
into and distribution within the EU, is increasingly
coming under more scrutiny by the competent
authorities. EU laws as well as Good Manufacturing
Practice (GMP) and Good Distribution Practice
(GDP) regulations (together, “GxP”) impose various
requirements on how a supply chain must be
designed, affecting importation and the supply
chain more broadly.
In the EU, these laws are being interpreted and enforced in a
stricter manner. As a result, pharmaceutical companies may be
forced to re-assess and potentially re-design or adapt the supply
chain for their medicinal products in the EU. Doing so requires
consideration of not only regulatory requirements, but also of
logistics, customs, and tax concerns.
Since the Court of Justice of the European Union (CJEU) ruled
in September 2023 (ECJ, 47/22) that a wholesaler in Europe may
not buy medicinal products from entities located outside the
EU, there is scrutiny on the compliant design of pharmaceutical
supply chains, specifically those where a product comes from
outside of the EU. There is particular focus on situations where a
product derives from the U.S. or is routed via non-EU countries
into the EU (e.g., the “Swiss Model”).
Beyond the aforementioned CJEU ruling, there are plans to
change EU law and specifically codify that even merely fiscal
purchase of products (e.g., distribution without “touching” the
products) is a “wholesale activity,” for which an EU wholesale
license is required. Compliance with GDP rules would also be
required, especially with the rule that an EU wholesale license
holder can only buy products from entities that hold an EU
wholesale license or EU manufacturing license.
An EU wholesaler may no longer purchase products from
entities outside of the EU. Fiscally importing products would
arguably require holding an EU manufacturing license for the
entity that is purchasing from outside of the EU, or otherwise for
redesigning the supply chain.
Designing a compliant pharmaceutical supply chain where
a product originates from outside of the EU requires holistic
thinking and care, and necessitates bringing together
stakeholders for regulatory, quality, logistics, intercompany
contract designing and tax.
Hein van den Bos
Partner
Amsterdam
Dr. Jörg Schickert
Partner
Munich
1
See Planning contract negotiations with treatment centers in Germany article on page 41
