In 2024, the Dutch Supreme Court referred questions to the Court of Justice of the European Union (CJEU) regarding the ability for EU Member States to introduce quantitative conditions for pharmacy preparations. On 9 October 2025, the Advocate General (AG) of the CJEU delivered his opinion (Case C-589/24).

In the EU, medicinal products may, with certain specific exceptions, only be placed on the market after having obtained a marketing authorization issued by the European Commission, or by the competent authority of the relevant EU Member State. 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."

The EU Directive 2001/83/EC excludes from its scope, 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"). Those pharmacy preparations do not require a marketing authorization and the compounding pharmacies do not need a manufacturing authorization. In the Netherlands, officinal formula preparations are only exempted from these requirements if the products are prepared on a "small scale," which is expressed as a numerical criterion.

The AG has proposed to the CJEU to answer that the Directive must be interpreted as not precluding national legislation, which exempts officinal formula preparations from the requirement to obtain a marketing authorization and a manufacturing authorization, provided that the monthly number of patients served by that pharmacy does not exceed the limit determined using a numerical criterion. The AG takes the view that – insofar the preparation and supply of the officinal formula is excluded from the scope of the Directive – the Directive does not in principle preclude EU Member States from adopting national legislation with respect to that activity, so long as there is compliance with the requirements imposed on EU Member States by EU law. In this case, those requirements concern, in particular:

• the achievement of the objectives pursued by the Directive,
• the treaties, and, especially,
• the free movement of goods.

A decision of the CJEU is expected in Q1 or Q2 of 2026. The outcome of the case could be of great importance for compounding pharmacies, as well as holders of marketing authorizations in the EU.