medicinal products

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On 23 October 2025, Advocate General (“AG”) Emiliou delivered his opinion in Case C-118/24: Laboratoires Eurogenerics and Theramex France.[1]

The AG opines on three key questions regarding the use of the decentralised procedure for generic medicinal products:

(i) The national courts of the EU Member States are allowed by EU law to judicially review the legality of a marketing authorisation (“MA”) granted via the decentralised abridged procedure where it is alleged that the medicinal product in question does not meet the criteria of a generic medicinal product. This is applies even if the judicial review is conducted by a national court in an EU Member State other that the reference Member State for the decentralised marketing authorisation procedure.

(ii) The applicant seeking such judicial review does not need to be the marketing authorisation holder for the reference medicinal product or the applicant for the generic marketing authorisation. The applicant could also be a third party with a vested interest, such as the marketing authorisation holder for a biosimilar medicinal product which will be competing with the newly authorised generic medicinal product. This conclusion by the AG remains unaffected by the fact that such applicant  may not be admissible if the action was brought at EU level to the Court of Justice of the European Union (“CJEU”) if the direct and individual concern of the applicant is not demonstrated. According to the AG, it is for the EU Member States in the framework of their procedural autonomy to decide whether a right to challenge an MA exists in these circumstances.

(iii) Chemically synthesised products are not precluded from meeting the criteria to be a generic of a reference biological medicinal product.

This third finding will, if followed by the CJEU, also apply to the centralised marketing authorisation procedure and arguably facilitate market access for synthetic copies of biological medicinal products. It would mean that, in practice, applicants for generics of biological medicinal products would not be required to submit additional pre-clinical and/or clinical data (as opposed to biosimilar applicants) and may potentially benefit, once authorised, from more advantageous pricing and reimbursement conditions (e.g., substitutability at pharmacy level which may not be available for biosimilar medicinal products).Continue Reading Can a chemically synthesised medicine be authorised as a generic of a biological medicine? And who can challenge this?

[1] This post and the paper it links to were prepared at the instruction of Novartis; it reflects the views of the authors.

Radiopharmaceuticals are a special type of medicinal products. Where they are prepared industrially or by a method involving an industrial process and are intended to be placed on the market in the European Union (‘EU’), they are subject to the rules of Directive 2001/83/EC on medicinal products for human use (the ‘Medicines Directive’). In addition, if patients are treated with radiopharmaceuticals, account should be taken of Directive 2013/59/EURATOM (the ‘Euratom Directive’) which lays down basic standards for the protection of individuals against radiation exposure.Continue Reading Development of a new EMA guideline on the clinical evaluation of ready to use radiopharmaceuticals[1]

On 10 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the “Aligned Pathway”. This is a joint initiative designed to streamline  the scheduling of the regulatory approval and health technology assessment processes in order to reduce the time before a new medicine is available on the NHS following the grant of the marketing authorisation (MA). The pathway supports the UK Government’s ambitions outlined in the 10-Year Health Plan for England and the Life Sciences Sector Plan to accelerate access to medicines and reduce regulatory burden, as discussed in our blog here.Continue Reading MHRA and NICE launch aligned approvals pathway

On 8 September 2025, the Court of Justice of the European Union (CJEU) received a preliminary request from the Bundesverwaltungsgericht, the German Federal Administrative Court BVerwG, referring a series of questions seeking interpretation on the applicability of certain rules to parallel trade of medicines, including whether German language and packaging requirements are proportionate or compatible with EU law.  The request follows an order for a preliminary reference made by the BVerwG in March 2025.  Notably, the request does not disclose the identity of the parallel importer, the manufacturer of the medicinal product, or the name of the product itself.Continue Reading CJEU to Clarify Rules on Packaging Requirements in Parallel Trade of Medicines

The European Commission has published new Guidelines on the details of the various categories of variations (to the terms of marketing authorisations (“MA”) for medicinal products) (“Variations Guidelines”).

The new 2025 Variations Guidelines replace the older 2013 Variation Guidelines, and support the implementation of the amended Regulation (EC) No 1234/2008 (“Variations Regulation”) (see our BioSlice blog post), which entered into force in January 2025. The Variations Guidelines provide detailed guidance for marketing authorisation holders (“MAH”) on modifying and updating their MAs, the procedures to follow and the related requirements.

Overall, the new Guidelines provide greater flexibility and clarity in certain aspects of the variation procedures. At the same time, they introduce new obligations for MAHs that should be taken into account by pharmaceutical companies going forward.

In this blog, we highlight some of the key changes introduced by the Variations Guidelines.Continue Reading European Commission Publishes New Variation Guidelines for Medicines

On 21 May 2025, the European Parliament and Council reached a provisional agreement on a new Regulation which establishes an EU-level framework on compulsory licensing of patents for any crisis emergency-related products in the EU, including medicinal products. The draft legislation, published in 2023, must now be endorsed and formally adopted by both the Parliament and the Council, expected in the coming months.Continue Reading One step closer to EU-wide compulsory licences for crisis management

Introduction

On 4 June, EU Member States, meeting in the Council of the European Union (‘Council’), have agreed on a position on the pharmaceutical reform package.

This agreement was reached despite significant divergences between EU Member States in the preceding weeks. It marks a key milestone in the process for adoption of the EU revision of EU’s general pharmaceutical legislation, as it sets out the Council’s position for the trilogue negotiations to find a text agreeable to the Parliament and the Council, which can now begin.

The innovative pharmaceutical industry will welcome aspects of the Council’s adopted negotiating mandate as it provides greater certainty with regards to regulatory data protection and it lightens some of the obligations introduced in the European Commission proposal for reform of the EU pharmaceutical legislation adopted in April 2023 and the European Parliament’s position adopted on 10 April 2024 (see our detailed advisory). At the same time, the Council has adopted positions on some aspects of the proposals that could be seen as less favourable to industry.

We discuss some of the key provisions and changes in the Council’s adopted position below. This is, however, not covering all elements of the reform of the EU pharmaceutical legislation and the final outcome of the legislative process remains uncertain.Continue Reading Council of the European Union backs reforms to the EU Regulatory Framework for Medicinal Products

Do discount campaigns on prescription-only medicines (POMs) run by mail order pharmacies lure patients into consuming medicinal products? The European Court of Justice (CJEU) in the case of Apothekerkammer Nordrhein (C-517/23) has held that they do not.

Following on from the AG Opinion of Advocate General Szpunar, which we provided an update on earlier in the year, this case is the latest in a stream of cases on advertising practices involving DocMorris, a Dutch mail-order pharmacy that supplies medicines to end customers in Germany. The CJEU concluded that the discount campaigns regarding unspecified POMs do not fall within the definition of “advertising of medicinal products” (Article 86(1) Directive 2001/83) as the discount is implemented at the point of purchase of the POM.  The decision of which product to prescribe has already been taken by a doctor and all the patient is left to do is choose the dispensing pharmacy. As such, the Court held that the purpose of the discount campaign is not to encourage patients to purchase medicinal products. Rather, it is simply to attract them to a specific pharmacy.

The facts of the case are set out in our previous blog available here.Continue Reading An update from the European Court of Justice on discount campaigns run by mail order pharmacies

On January 1, 2025, new UK-wide arrangements for the supply of medicines came into effect on account of the “Windsor Framework.” The overarching aim is to secure the long-term stability of the supply of medicines to Northern Ireland (NI), ensuring that medicines will be available at the same time, and on the same basis, across…

Do discount campaigns on prescription-only medicines (POMs) run by mail order pharmacies lure patients into consuming medicinal products?

Advocate General Szpunar has opined that they do not. The opinion comes in the latest of a stream of cases on advertising practices involving DocMorris (Case C-517/23), a Dutch mail-order pharmacy that supplies medicines to end customers in Germany. The AG concluded that the discount campaigns regarding POMs do not fall within the definition of “advertising of medicinal products” (Article 86(1) Directive 2001/83) as the discount is implemented at the point of purchase of the POM.  The decision of which product to prescribe has already been taken by a doctor and all the patient is left to do is choose the dispensing pharmacy. As such, the purpose of the discount campaign is not to encourage patients to purchase medicinal products. Rather, it is simply to attract them to a specific pharmacy.Continue Reading When discount campaigns regarding prescription only medicines do not fall within the definition of advertising in the EU