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15 Sep 2026, 11:03 am
The manufacture and sale of human medicines is tightly regulated on public health grounds in the EU. The law generally requires businesses to obtain a manufacturing authorisation to produce medicines, and a separate marketing authorisation to supply them to customers. However, there is some scope for pharmacies to prepare and supply medicines without such licences.
Below, we look at how the scope of those rules for pharmacies differ across the EU, explore what the EU’s highest court said when it examined the Dutch framework, and explain why its ruling is set to have continued relevance under a package of changes proposed to EU pharmaceuticals law.
The EU’s 2001 human medicines directive sets out a raft of rules designed to ensure that medicines developed for use by people are both safe and effective. The directive, among other things, generally requires that businesses obtain authorisation for manufacturing such products and separate authorisation to then market those medicines. However, some activities – including those that pharmacies can undertake – fall outside the scope of the directive’s rules.
Article 3(1) provides that any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient is outside the scope of the directive.
Similarly, Article 3(2) further states that the directive – and therefore the authorisation requirements within it – does not apply to “any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question”.
Earlier this year, the Court of Justice of the EU (CJEU) confirmed that medicines that satisfy the Article 3(2) requirements are entirely out of scope of the directive. It means that the products also fall outside of the scope of the rules individual EU countries draw up to transpose the directive into national frameworks – including the rules around authorisations applicable to in-scope medicines.
However, this does not mean medicines that meet the Article 3(2) criteria are entirely unregulated. The court confirmed EU countries can impose their own national rules on the pharmacy preparation and supply of the otherwise out-of-scope products their own national “competencies” on health.
The underlying case, referred to the CJEU by the Supreme Court of the Netherlands, concerned a dispute between a pharmaceutical manufacturer and a pharmacy over the pharmacy’s activities in the Netherlands. Almirall challenged Infinity Pharma’s preparation and supply of Psorinovo, a rival medicine to its psoriasis drug Skilarence. Both products contain the same active ingredient, dimethyl fumarate.
According to Almirall, the volume of Psorinovo that Infinity Pharma – and then Pharmaline, after its acquisition of Infinity Pharma – prepared and supplied exceeded limits stipulated in Dutch law. Its case is that Dutch law provides that it can only supply the product to up to 50 patients per month under the way it has regulated products falling within the Article 3(2) criteria.
Dutch legislators chose to impose numerical limits on pharmacies’ retail supply of products. In setting those limits, the Netherlands imported wording from Article 40 of the human medicines directive, which concerns manufacturing authorisations. Article 40 (2) provides exemptions to that rule, specifically that no manufacturing authorisation is required “for preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorized in the member states to carry out such processes”. It is the wording ‘solely for retail supply’ that spurred the Dutch to impose numerical limits.
In its ruling, however, the CJEU was clear that EU countries are not bound to account for the Article 40 wording when writing rules for products falling within the Article 3(2) criteria. It confirmed how those countries have a wide degree of discretion over their regulation of those products and that, since those products fall outside the scope of the directive, that degree of discretion is not qualified by Article 40 or indeed by “the level of harmonisation effected by [the 2001 directive]” as a whole. In that respect, it confirmed that this “has no effect on the margin of discretion which the member states have when adopting legislation concerning medicinal products that come within the scope of Article 3(2) of that directive, or on the interpretation thereof”.
Analysis by Pinsent Masons shows that other EU countries have taken very different approaches to the way in which they regulate pharmacy preparations and supply of medicines in the case of products falling within the Article 3(2) criteria.
In France, for instance, the general position under the French Public Health Code is that pharmacy-prepared medicines intended to be dispensed directly to patients will benefit from exemption to marketing authorisation requirements, although the activities the pharmacies undertake in that regard are still subject to pharmacy-specific general rules and compliance obligations in force in the country.
In 2023, however, French law was amended to pave the way for special rules to be written up for pharmacy preparations and supply of medicines to address shortages or discontinuation of certain medicines or serious public health emergencies.
Under that law, the French minister of health can exempt pharmacy-prepared medicines from marketing authorisation requirements for as long as a shortage, discontinuation or health crisis exists. If introducing such special rules, French authorities must, among other things, set out the composition, manufacturing process and quality requirements applicable to the preparation of the relevant medicines by pharmacies. In addition, pharmacies would face duties to report on their monthly production. The exemption would be said to expire automatically once a shortage, discontinuation or health crisis ends.
In Germany, a distinction is made between two categories of medicinal products manufactured in pharmacies.
The first category is medicines prepared in response to prescriptions for a specific patient, known as extemporaneous preparations. These are exempt from marketing authorisation requirements.
Extemporaneous preparations are exempt because they are not considered ‘finished medicinal products’ under German medicines law. Finished medicinal products are medicines either manufactured in advance and placed on the market in packaging intended for supply to the consumer; intended for supply to consumers whose preparation involves an industrial process; or which, with the exception of products manufactured in pharmacies, are manufactured commercially. Preparation of finished medicines is subject to marketing authorisation.
The second category is so-called stock preparations – medicines manufactured in advance in response to demonstrably frequent medical or dental prescriptions, in quantities not exceeding 100 ready-for-dispensing packages per day, as part of the pharmacy’s ordinary operations, with the essential manufacturing steps carried out within the pharmacy and the products intended for supply under the pharmacy’s existing operating licence.
While these preparations qualify as finished medicinal products because they are manufactured in advance, they do not require a marketing authorisation if all the other conditions for exemption provided for in German medicines law are satisfied. Notably, this includes the batch-size limit of 100.
In terms of whether a prescription practice is regarded as “frequent”, this will be considered the case in Germany if it is submitted at least daily or, in the case of complex compounded medicinal products, at least once a week.
On the essentiality of manufacturing in a pharmacy, German courts have consistently held that packaging and labelling are not, in themselves, sufficient to qualify as essential manufacturing steps, provided that these operations do not require pharmaceutical expertise or specialist professional control. The decisive factor is whether the manufacturing steps carried out outside the pharmacy are of lesser importance compared with those undertaken within the pharmacy. This determination requires a holistic assessment of the manufacturing process as a whole.
In Ireland, the position is different again. There, regulations set out separate exemptions for pharmacies from both manufacturing and marketing authorisation, with conditions attached.
In relation to supply, guidance produced by pharmacies regulator the Pharmaceutical Society of Ireland confirms that there are only two circumstances in which unlicensed supply of pharmacy-prepared medicines is permitted. In essence, this is either where the pharmacies have a doctor’s prescription and the product in question is intended for use by a patient or patient group under that doctor’s responsibility to meet patient needs, or where patients themselves request the product and it has been made up by the pharmacy in line with pharmacopeia requirements.
The guidance sets out requirements for pharmacies to keep written records of the medicines they prepare, and notes that whilst there is no explicit restriction on preparing batches in order to maintain a limited stock of a product, the shelf life of products might make this impracticable. In addition, it is not permitted for one pharmacy to wholesale products prepared by it to another pharmacy without a licence.
EU law makers are currently in the process of negotiating reforms to the EU’s pharmaceuticals legislation. Late last year, the European Parliament and Council of Ministers reached provisional agreement on the package. It includes a new regulation, which will have direct effect across the EU when adopted, and new directive, which EU countries will need to implement into national frameworks.
Minutes from a European Medicines Agency (EMA) steering group meeting held in July (6-page / 193KB PDF) suggest that it will be December this year before the package is adopted, and a further two years after that before the rules take effect.
Like with the current framework, the proposed new regime provides for certain medicines prepared and supplied by pharmacies to be out of scope of the EU regime.
According to the text of Article 1(5) of the new directive that has been provisionally agreed (661-page / 2MB PDF), “medicinal products prepared in a pharmacy in accordance with a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question” will be out of scope – except to the extent that the product in question is one that is subject to a central authorisation procedure overseen by the EMA, listed in points one and two of Annex I of the proposed new regulation (425-page / 1.65MB PDF).
If, as expected, this text is formally adopted, it will closely mirror the existing Article 3(2) criteria and the CJEU’s ruling in relation to its scope will remain relevant.
As a consequence, it seems likely that multinational pharmacy brands will continue to have to navigate a patchwork of different exemptions to understand the extent to which they can prepare and supply medicines without authorisation across the EU for years to come.
Co-written by Virgina de Freitas, Karen Gallagher and Wesley Horion of Pinsent Masons.
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