The Aesgp (Association of the European Self-Care Industry), Efpia (The European Federation of Pharmaceutical Industries and Associations) and Medicines for Europe have published a position paper containing a set of recommendations on how to make package leaflets for medicines more comprehensible to patients in order to ensure their appropriate, safe and effective use.
The Constitutional Court has set the public hearing for 22 May 2024, to discuss the legitimacy of the payback regulation for medical devices. Hundreds of manufacturers of medical devices are awaiting the Constitutional Court’s decision, since, should the Court confirm the legitimacy of the legislation in question, they will be required to pay EUR 1.1 billion on account of the expenditure overruns for the four-year period 2015-2018, in addition to the payback due for the following years.
In a recent decision, the Superintendence of Companies determined that an Excel-based risk matrix of the Self-Control and Integral Management System of Money Laundering, Terrorism Financing and Financing of the Proliferation of matrixes and of the Business Transparency and Ethics Program was insufficient because it did not allow to individualize, measure, assess and mitigate the risks identified.
On 23 April 2024, the Federal Senate approved Bill 6,007/2023, which originated as Bill 200/2015, and which generated intense debate among all those involved in the clinical research ecosystem. While the bill was supported by the economic sectors and part of academia due to the stability and security it brings to clinical research in Brazil, various social segments, part of academia and government authorities who are members of the system raised concerns about the possibility of weakening national ethical guidelines and dismantling the CEP/CONEP system.
On 10 April 2024, the Hong Kong Court of Final Appeal (CFA), Hong Kong’s highest court, delivered its judgment in Tam Sze Leung & Ors v Commissioner of Police [2024] HKCFA 8, affirming the validity of the ‘No Consent Regime’ (“Regime”) of the Hong Kong Police. The Regime encompassed a practice of issuing “Letters of No Consent” to financial institutions for customer accounts that contain suspected proceeds of crime, thereby triggering informal freezes on these accounts.
On 28 March 2024, the Health Sciences Authority released updates to the registration of therapeutic products as part of its continued efforts to improve regulatory efficiency and enhance clarity in the regulatory requirements and processes.
On 8 April 2024, the Health Sciences Authority issued an update on products found and reported by overseas regulators to contain potent ingredients that are prohibited and may lead to side effects.
By means of Resolution No. 12/2024, published in the Official Gazette on 24 April 2024 (“Resolution”), the Secretariat of Industry and Commerce amended the regime of advertising of goods and services involving an offer to an undetermined audience; it also repealed Resolution No. 915/2017. The Resolution’s main purpose is to modify the regulations governing advertisements so that they are clearer, more understandable, and useful for consumers. The aim is to simplify the current regime and prevent consumers from being “over-informed,” which could make it difficult for them to make appropriate purchasing decisions.
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We are pleased to present you with the latest update of Product Risk Radar (linked to https://www.globalcompliancenews.com/product-risk-radar/), our online content hub that covers the latest important legal developments in product regulatory and liability risk. The diverse range of articles helps you navigate the increasingly challenging landscape of the newest legal…