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  • Article

    Belgian Regulator Provides Safety Advice On Insects Intended For Human Consumption

    The Belgian Food Safety Agency recently provided advice on the microbial and chemical safety of insects intended for human consumption.
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EFSA Announces More Open Plenary Meetings In Brussels

    On January 22, 2015, EFSA announced it would make it easier for external observers to attend open plenary meetings by increasing its scientific panels and Scientific Committee open plenary meetings to be held in Brussels.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    WEBINAR VIDEO | Belgium's Medicines Reimbursement Reform (Video)

    During this webinar, Kirian Claeyé and Bart Junior Bollen guide you through the eagerly anticipated reform of the reimbursement procedures for medicines in Belgium.
    BelgiumFood, Drugs, Healthcare, Life Sciences
    ALTIUS
    ALTIUS
  • Article

    Trump Administration Proposes Ambitious AKS Rewrite On Drug Rebates, But Needs Answers To Big Questions

    In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs
    GlobalFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    Brexit Snapshot: Food & Beverage

    The default legal position is that the UK will leave the EU automatically at 11pm on 29 March 2019 with no "deal" in place, unless something else is agreed.
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    FDA Publishes Final Guidance On ANDA/505(B)(2) NDA Pathways

    On Thursday, FDA published the final guidance document, "Determining Whether to Submit an ANDA or a 505(b)(2) Application" that contains minor revisions ...
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    FDA Issues Final Guidance On Added Sugars Labeling For Honey, Maple Syrup, Other Single-Ingredient Sugars And Syrups, And Certain Cranberry Products

    On June 18, the Food and Drug Administration (FDA) issued its final guidance document on added sugars labeling for honey, maple syrup, and other single-ingredient sugars and syrups; and certain cranberry products.
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    Early Access To Pharmaceutical Products In Major European Markets

    The European Medicines Agency (EMA) has committed early patient access to new medicines, particularly those that target an unmet medical need or are of major public health interest.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    Council Position On EU Pharma Package Adopted

    On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package'.
    European UnionFood, Drugs, Healthcare, Life Sciences
    A&O Shearman
    A&O Shearman
  • Article

    Recent Developments In Belgium Regarding Production And Research Into Cannabis Products

    Following the change of mind that is taking place in many jurisdictions around the world, Belgium is gradually taking steps relating to the production and research into cannabis products for medicinal purposes.
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Dentons
    Dentons
  • Article

    Two Changes In Belgian Food Law In 2023

    Food law is extensively harmonized throughout the EU, but national law still has a role to play. In this short article, we look at two developments in Belgian food law that have taken place in 2023...
    BelgiumFood, Drugs, Healthcare, Life Sciences
    ALTIUS
    ALTIUS
  • Article

    Court Of Justice Of European Union Lowers Evidence Standard In Vaccine-Liability Case

    Under Article 4 of the Directive, a person injured by a defective product should prove the damage, the defect and the causal relationship between defect and damage.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Van Bael & Bellis
    Van Bael & Bellis
  • Article

    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...
    BelgiumFood, Drugs, Healthcare, Life Sciences
    ALTIUS
    ALTIUS
  • Article

    ECJ Rules On Misleading Labelling Of Foodstuffs

    On 4 June 2015, the Court of Justice of the European Union (the "ECJ") ruled on a request for a preliminary ruling from the German Supreme Court (Bundesgerichtshof) regarding the misleading labelling of foodstuffs...
    European UnionConsumer Protection
    Van Bael & Bellis
    Van Bael & Bellis
  • Article

    Two Kiwis Per Day Chase Constipation Away – European Commission Approves Health Claim For Fruit

    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...
    BelgiumFood, Drugs, Healthcare, Life Sciences
    ALTIUS
    ALTIUS
  • Article

    Brussels Court Of Appeal Refers Questions To ECJ On Validity Of Prohibition On Price Reductions For Tobacco Products

    In an interim judgment of 5 May 2015, the Brussels Court of Appeal referred three questions for a preliminary ruling to the Court of Justice of the European Union.
    European UnionCorporate/Commercial Law
    Van Bael & Bellis
    Van Bael & Bellis
  • Article

    The New EU "Pharma Package": Preparing For The Trilogues

    On June 4, 2025, after nearly two years of intense debate and negotiation between the 27 EU Member States, the Council of the European Union adopted its position on the proposed overhaul of the EU general pharmaceutical legislative framework known as the new Pharma Package.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Crowell & Moring LLP
    Crowell & Moring LLP
  • Article

    EU Commission Conditionally Approves Three-Part GSK/Novartis Deal

    On 28 January 2015, in two separate decisions, the European Commission conditionally approved a complex transaction between pharmaceuticals producers GlaxoSmithKline (GSK) and Novartis.
    European UnionAntitrust/Competition Law
    Van Bael & Bellis
    Van Bael & Bellis
  • Article

    EU Court Of Justice Confirms Validity Of Tobacco Products Directive

    Subject to a few exceptions, EU Member States should apply the national implementing measures of the TPD as from 20 May 2016.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Van Bael & Bellis
    Van Bael & Bellis
  • Article

    European Medicines Agency Publishes Q&A On Clinical Trial Data Transparency

    Following the entry into application of the Clinical Trials Regulation (EU) 536/2014 (CTR) for all initial clinical trial applications on 31 January 2023, the European Medicines Agency...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Cooley LLP
    Cooley LLP

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