LS&HC Horizons 2023 - Flipbook - Page 62
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Europe
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EU supply chain issues for medicinal products
Supply chain structures of import and
distribution of medicinal products in the EU
should be carefully set up. Due considerations
need to be taken for account logistics, but also
for regulatory and customs requirements, as
well as tax considerations. Often, the physical
product flow and the legal product flow are not
in sync with regulatory requirements. Without
careful planning, such regulatory requirements
may jeopardize tax optimization.
Medicines shortages are also on the radar of the
authorities in several EU Member States as well
as of the European Medicines Agency (EMA).
In 2022, EMA published key principles and
examples of good practices to support patients
and health care professionals in preventing and
managing shortages of medicines. Structuring
supply chains and combatting medicines
shortages will remain key areas for companies
and regulators in the EU in 2023.
In addition to structuring questions around
import and distribution, supply chains of
medicines are under scrutiny of the EU
authorities. In October 2022, the European
Commission published its main findings
from a Structured Dialogue with stakeholders
in the pharmaceutical supply chain regarding
global supply chain vulnerabilities and
risks of shortages. Topics raised included
identifying critical medicines, increasing
manufacturing capacity in the EU, optimizing
regulatory environment, promoting green
and digital innovation in manufacturing,
and global cooperation.
Hein van den Bos
Partner, Amsterdam
Dr. Jörg Schickert
Partner, Munich
Band One for Life
Sciences in Chambers
Europe-wide, 2022