Despite EU Harmonisation, Member States May Impose Authorisation Requirements On Pharmacy-prepared Medicines, Rules EU Court Of Justice

Introduction 

Under EU pharmaceutical law, certain medicines fall outside the scope of Directive 2001/83/EC (i.e. the Community code on medicinal products for human use). This includes “magistral formulae” (prepared in a pharmacy for an individual patient on prescription) and “officinal formulae” (prepared in a pharmacy in accordance with a pharmacopoeia and supplied directly to that pharmacy’s patients). As a result, they are not subject to the Directive’s requirements, including marketing and manufacturing authorisations. This raises the question to what extent Member States may regulate these exemptions in national law. In particular, can they impose additional conditions – such as requiring authorisation in certain circumstances – not foreseen by EU law? That issue arose before the EU Court of Justice (“CJEU”), in Case C-589/24, following a reference from the Dutch Supreme Court concerning national rules limiting the officinal formula exemption based on the quantity supplied to patients by pharmacies per month.

Factual background

Under Dutch law, the officinal formula exemption only applies if the medicine is prepared and supplied “on a small scale”. In practice, the Dutch authorities interpret this to mean that no more than 50 different patients can receive the product each month for long-term use. This rule was at the heart of a dispute between pharmaceutical company Almirall and the pharmacies Infinity and Pharmaline, who allegedly exceeded that limit.

Almirall produces and distributes Skilarence®, a treatment for psoriasis, and holds both a marketing and manufacturing authorisation for it. Meanwhile, the pharmacies Infinity and Pharmaline prepared and supplied Psorinovo® on their premises – a medicine with the same active ingredient and indication as Skilarence®- but without any marketing or manufacturing authorisation, instead relying on the officinal formula exemption under EU and Dutch law.

Almirall sought injunctions against Infinity and Pharmaline in the lower courts for violation of a regulatory requirement and to compel the pharmacies to comply with the quantitative limit for officinal formulae under Dutch law. The dispute eventually reached the Dutch Supreme Court, which referred the case to the CJEU. The question for the CJEU was essentially whether the officinal formula exemption under EU law prevents a Member State from imposing a national rule that requires the preparation and supply of medicines falling under that exemption to be carried out “on a small scale” – effectively a rule expressed through a specific numerical threshold.

What the CJEU decided

The Court began by recalling its two-step test to decide whether a medicine falls under the EU Community code. First, the product must be industrially produced. Second, it must not fall into one of the categories excluded by Article 3. Under Article 3(2), a medicine is excluded if it qualifies as an “officinal formula”, which requires that it is:

Because officinal formulae are excluded from the Community code, regulating them falls squarely within the competence of the Member States. They do not need to harmonise their rules with other countries in this area and are free to impose national authorisation requirements for the preparation or supply of such medicines. In doing so, said the CJEU, they are not implementing the Community code, which is irrelevant for judging the legality of these national rules and cannot limit the Member States’ discretion.

 In this case, if Psorinovo® meets all the conditions to qualify as an “officinal formula”- a determination for the referring court to make – it falls outside the scope of the Directive, leaving potential restrictions to national law. As a result, the Dutch rules were not found to violate the Community code, meaning that the Netherlands can require authorisation for pharmacy-prepared medicines based on a quantitative threshold. 

Conclusion

This case is a reminder that not all areas of pharmaceutical regulation are harmonised by EU law. Some regulatory discretion still rests with Member States, which means that medicines falling outside the scope of the Community code can, in principle, be regulated in 27 different ways (if not covered by any other EU act), adding complexity to the system. At the same time, this gives Member States the opportunity to use national law to treat certain pharmacy-prepared products as if they were industrial medicines, subjecting them to similar authorisation requirements (and this is anticipated to still be the case once the EU Pharma Package is in place). In many Member States, pharmaceutical companies will be able to enforce these national restrictions directly if they are violated, and it is unlikely that such enforcement could be challenged using the Community code, since the CJEU has now effectively cut off that line of argument.

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