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  • Article

    Court Of Appeal Permits Repackaging Of Parallel Import Pharmaceuticals

    On 14 September 2015, the Court of Appeal of Mons permitted parallel imported pharmaceutical products to be repackaged and sold in package sizes that are predominant on the Belgian market.
    BelgiumIntellectual Property
    Van Bael & Bellis
    Van Bael & Bellis
  • Article

    Three 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 three developments in Belgian food law that have taken place in 2023...
    BelgiumFood, Drugs, Healthcare, Life Sciences
    ALTIUS
    ALTIUS
  • Article

    The European Commission Launches Public Consultation On The MDR And IVDR

    The European Commission has opened the floor for a discussion on whether the EU medical devices legislation is effective, efficient, relevant, coherent and valuable.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Arnold & Porter
    Arnold & Porter
  • Article

    "Shrinkflation": A New Obligation For Distributors Regarding The Display Of Their Products

    Shrinkflation is a commercial practice which consists of reducing the size of a product while maintaining or even increasing its price. With the increases in raw materials costs.
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Osborne Clarke LLP
    Osborne Clarke LLP
  • Article

    The EU Pharma Package: Formal Adoption In Sight

    With formal adoption by both the Council of the EU and the EU Parliament expected by summer 2026, stakeholders should start looking into implementation preparations...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Crowell & Moring LLP
    Crowell & Moring LLP
  • Article

    Parallel Trade: Rebranding Of Generic Medicine To Originator Brand Name Constitutes Trade Mark Infringement

    In reaching this conclusion, the Court referred to the Belgian regulatory framework which embraces the principle of "therapeutic freedom" which, as a rule, prohibits substitution in the deliverance of medicines.
    European UnionIntellectual Property
    Van Bael & Bellis
    Van Bael & Bellis
  • Article

    FDA Addresses Industry Feedback On Routine Inspections By Formalizing Processes And Standards In A Draft Guidance

    On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    FDA Issues Draft Guidance On Reducing Microbial Food Safety Hazards In The Production Of Seed For Sprouting

    FDA recently released a Draft Guidance for Industry entitled, "Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting" ("Draft Guidance"). The Draft Guidance
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    ECJ Provides Guidance On Parallel Imports From New Member States

    The Court of Justice of the European Union issued a judgment interpreting the Specific Mechanism for parallel importation of pharmaceutical products from new EU Member States shortly after their accession to the EU.
    European UnionIntellectual Property
    Van Bael & Bellis
    Van Bael & Bellis
  • Article

    New European Parliament Activities on Environment

    On July 27, 2004, the European Parliament Committee for Environment, Public Health and Food Safety (ENVI COM) will hold its first meeting under the sixth Parliamentary Term.
    BelgiumFood, Drugs, Healthcare, Life Sciences
    McKenna Long & Aldridge LLP
    McKenna Long & Aldridge LLP
  • Article

    English Court Orders Disclosure Of Customer Information At Interim Stage

    On 28 February, the High Court handed down an interim judgment in Eli Lilly v Neopharma and Anor (Howrey acting for Eli Lilly) in which it ordered the disclosure of information relating to sales of the (allegedly) infringing pharmaceutical Olanzapine Neopharma.
    BelgiumIntellectual Property
    Howrey LLP
    Howrey LLP
  • Article

    Taste Of Food Product Does Not Qualify For Copyright Protection

    Convinced that these practices infringed its copyright in the taste of "Heksenkaas", Levola brought an action against Smilde for copyright infringement.
    BelgiumIntellectual Property
    Van Bael & Bellis
    Van Bael & Bellis
  • Article

    ECJ Dismisses Astrazeneca Appeal Over Abusive Misuse Of Patent System And Regulatory Procedures Involving Anti-Ulcer Pharmaceutical Losec®

    On 6 December 2012, the Court of Justice of the European Union handed down its judgment in the AstraZeneca case, following an appeal against a 2010 judgment of the General Court which itself had upheld in large part an earlier decision of the European Commission that had imposed a € 60 million fine on the company for abuse of the patent system and regulatory procedures in the pharmaceutical sector.
    European UnionAntitrust/Competition Law
    Van Bael & Bellis
    Van Bael & Bellis
  • Article

    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...
    European UnionFood, Drugs, Healthcare, Life Sciences
    ALTIUS
    ALTIUS
  • Article

    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...
    European UnionFood, Drugs, Healthcare, Life Sciences
    ALTIUS
    ALTIUS
  • Article

    Updates To The EU Pharmacovigilance Rules: Key Takeaways For Marketing Authorisation Holders

    On 22 July 2025, the European Commission adopted Implementing Regulation (EU) 2025/1466 ("Regulation"), updating the EU pharmacovigilance (or "PV") rules by way of amendments...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Arnold & Porter
    Arnold & Porter
  • Article

    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, Marvesa Rotterdam NV, and the Federal Agency...
    European UnionFood, Drugs, Healthcare, Life Sciences
    ALTIUS
    ALTIUS
  • Article

    Belgian Pharma Law Summer Blog Series (Part 1): The Act Of 30 May 2026 Containing Various Provisions On Medicinal And Health Products

    Belgium introduces significant reforms to pharmaceutical law through the Act of 30 May 2026, addressing critical medicine shortages through enhanced export controls and stock allocation measures. The legislation also modernizes the Federal Agency for Medicines and Health Products' operational framework and adapts clinical trial regulations to support decentralized research models.
    BelgiumFood, Drugs, Healthcare, Life Sciences
    ALTIUS
    ALTIUS
  • Article

    EMA Guidance On Comparability Exercise For ATMPs

    On 13 December 2019, the European Medicines Agency ("EMA") published a Questions and Answers document ("Q&A")
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Arnold & Porter
    Arnold & Porter
  • Article

    Plastic Food Contact Materials: Declaration Of Compliance Soon To Reflect Compliance With New Purity Requirements

    On 21 February 2025, the EU Commission adopted Regulation (EU) 2025/351, the so-called 19th Amendment to the Plastics Regulation (Regulation (EU) No 10/2011)...
    European UnionEnvironment
    Mayer Brown
    Mayer Brown

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