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  •  
    10/02/2025
    United Kingdom

    Increased regulation of high risk and weight loss medication – will new GPhC guidance strengthen safeguards and prevent unsafe online supply?

    As access to medication becomes more convenient with the increased use of online pharmacies, concerns have emerged about the safety and appropriateness of prescribing certain drugs at a distance, particularly high-risk drugs such as weight loss medication. As demand for medication supply online increases, with popularity surging as a result of social media for high-risk drugs such as weight loss medication, questions around proper patient screening and potential misuse have been raised. The General Pharmaceutical Council (GPhC) have addressed this issue and supplying at a distance generally, in...
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  •  
    06/02/2025
    Belgique

    Du projet de réforme fiscale aux sables mouvants de l’Arizona

    GB NL
    1. Les matières abordées par l’accord Après de longs mois de propositions et de négociations, les partenaires de l’Arizona (du nom de la coalition appelée à former le nouveau gouvernement fédéral) sont parvenus à un accord sur de nombreux sujets.Mais qu’en est-il des aspects fiscaux ?2. Sociétés2.1. Revenus définitivement taxés Le régime fiscal dit des « Revenus Définitivement Taxés » (découlant de la transposition en droit...
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  •  
    06/02/2025
    Hongrie

    Hungary issues decrees on cybersecurity audit and annual supervision fee

    On 31 January 2025, Hungary published two highly anticipated cybersecurity decrees under the Hungarian Cybersecurity Act, which transposes the NIS2 Directive. The decrees include SZTFH Decree 1/2025 (I. 31.), which contains the procedures for conducting a cybersecurity audit and the maximum fee for a cybersecurity audit; and SZTFH Decree 2/2025 (I. 31.), which details the amount and payment of the yearly cybersecurity supervision fee.Scope of cybersecurity auditsSZTFH Decree 1/2025 (I. 31.) lays down detailed rules on audit methodology, related examination methods, and the criteria for evaluating...
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  •  
    05/02/2025
    Hongrie

    Hungarian ruling could make credit institutions increasingly liable for AML breaches

    A recent landmark judgment by the Metropolitan Court of Appeal may represent a pivotal shift in the tort liability of credit institutions stemming from violations of anti-money laundering (AML) regulations. According to the court, if a financial institution fails to suspend a suspicious transaction in violation of AML rules and executes a transaction involving funds originating from a criminal act, the financial institution may bear tort liability vis-à-vis the original victim of the fraud.The following article provides a detailed overview of this appellate court decision, and the implications...
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  •  
    27/01/2025
    United Kingdom

    Clinical Trials: UK regulatory landscape set for change

    IntroductionOn 12 December 2024, a significant milestone was reached in the evolution of the UK's clinical trial landscape as the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were laid before Parliament for debate (the “Updated Regulations”). The Updated Regulations are set to amend the UK’s existing regulatory framework, marking a pivotal shift in how clinical trials are conducted in the UK.With a 12-month implementation period, the Updated Regulations are expected to come into force in January 2026. We set out below some of the key changes contemplated...
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  •  
    24/01/2025
    Ukraine

    Ukraine introduces updated labelling regulations for medicines

    On 18 January 2025, new labelling requirements for medicinal products in Ukraine went into force. These amendments restrict promotional information on labelling, prohibit references to entities other than the manufacturer or marketing authorisation holder (MAH) on packaging, and grant new powers to the Ministry of Health and the Quality Inspectorate to suspend marketing authorisations and circulation of non-compliant medicines. Pharmaceutical companies must address these regulatory changes and ensure compliance.In a previous Law-Now article, we provided analysis of the official interpretations...
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