Tags: Regulatory
Belgian Pharma Law Summer Blog Series (Part 3): the recently passed ‘Bill containing various provisions on health’
In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Our third and final part examines the ‘Bill containing […]
Belgian Pharma Law Summer Blog Series (Part 2): the new ‘Article 10 guidance’ on pharmaceutical promotion
In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Part 2 focuses on the new guidance on the […]
Belgian Pharma Law Summer Blog Series (Part 1): the Act of 30 May 2026 containing various provisions on medicinal and health products
In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Part 1 focuses on the Act of 30 May […]
New EU sample retention rules coming up for veterinary medicines repackaged for parallel trade
The Veterinary Medicinal Products Regulation (EU) 2019/6 has applied in the EU since 28 January 2022, replacing Directive 2001/82/EC. The new rules on good manufacturing practice (GMP) will in turn be fleshed out by Commission Implementing Regulation (EU) 2025/2091, which will apply from 16 July 2026. In addition, the European Commission is introducing new GMP requirements concerning the retention of samples for veterinary medicinal products that are repackaged for parallel trade. This blog post briefly examines what these new obligations entail.
16 April 2026: AIFMD II Finally Takes Effect
After years of legislative process, the local transposition deadline of 16 April 2026 for AIFMD II (Directive 2024/927/EU) has finally arrived. This marks a significant milestone for the investment fund industry across the European Union, bringing with it a range of important changes for both fund managers and the vehicles they manage.
EU General Court bars patient association from challenging medicine authorisation refusal
In Case T‑278/25, the EU General Court recently dismissed as inadmissible a challenge brought by a patient advocacy association against the European Commission’s refusal to renew the conditional marketing authorisation for a treatment against Duchenne muscular dystrophy (DMD). The case is significant because it adds to the case law on contesting Commission decisions relating to the marketing of medicinal products. In this blog post, we look at how the Court came to the conclusion that the association lacked standing to litigate and use this as a basis for an informal categorisation of the existing case law.
Despite EU harmonisation, Member States may impose authorisation requirements on pharmacy-prepared medicines, rules EU Court of Justice
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 […]
EU General Court: technical vaccine data does not have to be disclosed on request
The EU General Court delivered a significant judgment concerning access to documents held by the European Medicines Agency (EMA), this time relating to a conditionally authorised COVID-19 vaccine. This case (T-623/22) serves as an addition to the elaborate case law on the balance between transparency in health matters and the protection of companies’ commercial interests. On this (rare) occasion, the commercial interests of the conditional marketing authorisation (‘MA’) holder prevailed, although an appeal is currently pending (C-38/26 P).
The new Product Liability Directive
The new Product Liability Directive (“PLD”) replaced the old Product Liability Directive (Directive 85/375/EEC) and aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global supply chains. It also focuses on improving the harmonisation of the common rules on liability for defective products and tackling the difficulties faced by victims when gathering evidence to prove product liability. This blog focuses on the main changes the PLD brings. Entry into force The […]
Belgian Parliament has adopted urgent 2026 healthcare budget measures: what’s the impact on the pharma industry?
Over the Christmas break, the Belgian Parliament adopted an urgent law with several measures linked to the approved 2026 healthcare budget, with effect from 1 January 2026. The law is intentionally limited to provisions that must enter into force immediately to ensure that the required savings and revenues are available from the start of the […]
EU Reaches Pharma Package Deal: Key Changes at a Glance
On 11 December 2025, following overnight negotiations, the Council and the European Parliament announced a political agreement on the long-awaited Pharma Package (see here). The reform seeks to update the EU’s pharmaceutical rulebook to facilitate access to safe and affordable treatments and bolster the life sciences sector’s competitiveness. While more detailed information is still trickling […]
Food Hygiene for Fish: EU General Court Requires Scientific Basis to “Clarify” the Law
Food company Mowi Poland successfully challenged the European Commission’s new hygiene rules governing ‘stiffening’—a specialised fish processing technique—on the grounds that the Commission failed to obtain mandatory scientific consultation. While the Commission defended its approach by characterising the measures as mere “clarification” of existing law and citing industry guidelines as support, the EU General Court […]
LSS: Challenging Government Decisions: Legal Strategies in Agri-food & Life Sciences
Government decisions can often have a significant impact on companies in the agrifood and life sciences sectors. But what options do you have if you disagree with such a decision? Which steps are available to you, and which route – administrative or judicial – is the most suitable in your case?
Titanium dioxide: General Court strikes down classification as human carcinogen and ECJ now confirms
The European Commission often relies on scientific evidence for its regulatory decisions. But when challenged, how much deference is owed to the regulator’s interpretation of the underlying science?
REACH obligation to register imported chemicals may be assumed by a person other than the buyer
Under the EU’s REACH Regulation 1907/2006, substances must be registered with the European Chemicals Agency before being imported. The duty to register lies with the importer. In practice, the act of ‘importing’ often involves multiples actors, including the seller, the buyer and various intermediaries who move the goods across borders. So, who then should register […]
Two kiwis a day to chase constipation away – European Commission approves fruit health claim
The European Commission has authorised a new food health claim recognising the digestive health benefits of green kiwifruit. The claim—“Consumption of green kiwifruit contributes to normal bowel function by increasing stool frequency”—has recently been added to the Union list of permitted claims under Regulation (EU) No 432/2012, following a five-year authorisation process. Food-related health claims […]
European Commission proposes new PPP labelling requirements
On 6 January 2025, the European Commission published a draft proposal aimed at further harmonising labelling requirements for plant protection products (PPPs) in the European Union (EU). The proposal intends to repeal the existing labelling rules and introduce certain new requirements, including mandatory digital labelling. Since the draft proposal has not yet been formally adopted, some changes to the final version remain possible.
CJEU C-793/22 Biohemp – Indoor Cannabis Cultivation: The CJEU Weighs in
The Cannabis sativa L. plant serves a wide range of purposes, many of which are uncontroversial. It can be grown in the EU, in which context it is commonly called ‘hemp’. The plant notably produces cannabidiol (CBD), which the Court of Justice of the European Union has unequivocally ruled is not a narcotic drug. Nonetheless, some EU Member States remain reluctant to accept hemp cultivation.
Belgium gears up to enforce the EU Deforestation Regulation
The EU Deforestation Regulation (EUDR) was published on 9 June 2023 and came into force on 29 June 2023. Member States, including Belgium, must establish legal frameworks for enforcement.
EU Court of Justice interprets import ban on Chinese animal products: fish oil for feed is not an exempted “fishery product”
On 21 March 2024, the EU Court of Justice (‘CJEU’) handed down its ruling in case C‑7/23, concerning a dispute between a feed company and the Federal Agency for the Safety of the Food Chain. The parties differed in their interpretation of an EU import ban on products of animal origin coming from China. The Council of State sought the CJEU’s guidance.
CJEU balances strict obligations for wholesalers of medicines with proportional penalties
On 21 September 2023, the EU Court of Justice (‘CJEU’) handed down its ruling in the Apotheke B. case (C-47/22), and it is a good example of the high threshold set by the EU Court of Justice to uphold the Community Code’s main aim of protecting public health.
EU citizens rally for medical cannabis but face a rigid European Commission
In the EU, access to medical cannabis is a matter of national policy. A group of citizens wants to change that by leveraging a citizens’ initiative and prompting the European Commission to act.
EU Court of Justice: Parallel importer may not remove PPP batch number
This blog post mainly focuses on the CJEU’s findings regarding the responsibility of parallel importers for ensuring the display of the original batch number on the product packaging.
How are the rules relating to the advertising and marketing of alcoholic beverages applied by Belgium’s Advertising Ethics Board?
Join us for a review of the Advertising Ethics Board’s decision-making practice in this respect by Mathieu Maniet and Nicolas Clarembeaux.