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Product Regulation & Liability

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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.

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amended the regime of advertising of goods and services involving an offer to an undetermined audience; it also repealed Resolution No. 915/2017.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.

Our popular Annual Compliance Conference, which attracts over 4,000 in-house senior legal and compliance professionals every year from across the world, will be taking place from 30 April – 6 June. We will be delivering our cutting-edge insights and guidance virtually on key global compliance, investigations and ethics trends.

The Thai Food and Drug Administration (FDA) has recently issued two notifications, namely the Notification of the Ministry of Public Health Re: Good Manufacturing Practice, B.E. 2566 (2023), and the Notification of the Ministry of Public Health Re: Good Importing and Sales Practice, B.E. 2566 (2023). These notifications aim to regulate the quality systems of medical device manufacturing facilities, as well as importers and sellers of medical devices.

The Government of Catalonia has recently published a guide on the advertising of medicinal products for human use. This guide provides new and updated advice on the understanding of the regulations on advertising on medicinal products. In particular, it focuses on advertising in the digital environment, analyzing the use of digital platforms and tools and providing recommendations for responsible advertising in accordance with the current sectorial regulatory framework.

The Italian Medicines Agency has summarized the distribution methods that can be applied in the event of shortages of drugs included in transparency lists. These measures can be implemented in order to guarantee pharmaceutical assistance at the regional level, avoid charges to citizens and optimize economic resources.

The EU Court of Justice, in its judgment given in Case C-291/22 P, annulled the European Medicines’s decision denying marketing authorization for a drug, finding that the evaluation process was vitiated by the presence within the Committee for Medicinal Products for Human Use of an expert who was in a situation of conflict of interest.