Life Sciences Horizons Brochure 2025 - Flipbook - Page 104
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2025 Horizons Life Sciences and Health Care
CJEU mulls questions over pharmacy compounding
In 2024, the Dutch Supreme Court referred questions
to the Court of Justice of the EU (CJEU) regarding
the ability for EU member states to require
pharmacies to obtain a marketing and manufacturing
authorization for medicinal products that are
prepared in pharmacies.
In the EU, regulations regarding the manufacturing and
marketing authorization of medicinal products are harmonized
in Directive 2001/83/EC (the “Directive”) and Regulation (EC)
No 726/2004 (the “Regulation”). Medicinal products may, with
certain specific exceptions, only be placed on the market after
having obtained a marketing authorization issued by the
competent authority of the EU member state in accordance with
the Directive, or by the European Commission in accordance with
the Regulation. In order to obtain a marketing authorization, an
appropriate data package must be submitted to the competent
authorities, including the results of pre-clinical tests and clinical
trials, regarding the quality, safety and efficacy of the medicinal
product. Further, a manufacturing authorization is required for
the manufacturing of medicinal products.
The requirement to obtain a marketing and manufacturing
authorization applies to medicinal products either “prepared
industrially” or “manufactured by a method involving an
industrial process.” In 2015, the CJEU ruled that characteristics
of “industrial preparation” include standardized production of
significant quantities of a medicinal product stocked and sold
wholesale, and large-scale or serial production of magistral
formulae sold in batches.
Excluded from the scope of the Directive are, among others,
medicinal products prepared in a pharmacy in accordance with
the prescriptions of the pharmacopoeia and intended to be
supplied directly to the patients served by the pharmacy in
question (“officinal formula”). The Directive does not set any
additional quantitative requirements. In the Netherlands,
officinal formula preparations do not require a marketing and
manufacturing authorization, but only insofar as the products
are prepared on a “small scale,” meaning they are prepared and
supplied to a maximum of 50 unique patients per month for
long-term use, and a maximum of 150 unique patients per month
for short-term use.
The CJEU has now been asked to clarify whether an interpretation
in conformity with the Directive allows EU member states to pose
any quantitative requirement for officinal formula preparations.
The outcome of the case could be of great importance for
compounding pharmacies as well as holders of marketing
authorizations in the EU.
Hein van den Bos
Partner
Amsterdam
Samantha van Dijk
Junior Associate
Amsterdam
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