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Product Regulation & Liability

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The Ministry for Productive Agriculture and Lands issued Administrative Ruling INSAI No. 007/2023 (“Administrative Guidelines”) on 6 June 2023, establishing the rules that regulate the registry, supervision and control of agro-ecological or organic consumables which became effective on 8 August 2023 (i.e., date of its publication in the Official Gazette).
The Administrative Guidelines also regulate activities related to the manufacture, formulation, import, export, commercialization, distribution, packaging, storage, sale, transport, application, release, advertising, quality control and research of Products for agricultural, industrial, domestic, public health and livestock use in Venezuela.

On 21 August 2023, the decree by which the Influencers Advertising Guide of the Federal Consumer Protection Office (PROFECO) was published, which is a reference tool for content creators, influencers, and the general public for due compliance with the provisions on advertising established in the Federal Consumer Protection Law.

The recent proliferation of artificial intelligence (AI) tools, particularly generative AI tools, has brought these questions to the forefront of ongoing conversations about the role that AI will play in the marketplace. As an advocate for and enforcer of consumer protection laws, the US Federal Trade Commission recently offered reminders and recommendations for companies offering digital products and AI tools.

On 26 July 2023, the Ministry of Health launched the Industry Transformation Map (ITM) 2025 for healthcare. The ITM 2025 refreshes the ITM for healthcare, which was first launched in 2017.
ITM 2025 focuses on four main areas: (i) strengthening Singapore’s research and innovation ecosystem; (ii) strengthening digital system enablers; (iii) attracting and retaining healthcare workers; and (iv) strengthening partnerships.

In the first two parts of this series, we provided an overview of the new US Food and Drug Administration regulatory requirements under the Modernization of Cosmetics Regulation Act of 2022 and the good manufacturing practices regulations FDA plans to establish. In Part III, we will review the new FDA draft guidance on the facility registrations and products listings as mandated by MoCRA.

A modification of the current fertiliser products regulation (Royal Decree 529/2023) has been published. This new Royal Decree 529/2023 improves the alignment of national regulations with Regulation (EU) 2019/1009 on EU fertiliser products to avoid tensions between these two regimes. The new regulation introduces provisions on certain mixtures of micronutrients, inorganic fertilisers based on ammonium nitrate and the criteria that sub-products must meet in order to be classified as such.

The Spanish Government has approved a new Royal Decree 666/2023 completing the regulatory framework for veterinary medicinal products. This regulation seeks to update the regulations governing veterinary medicinal products in accordance with current scientific advances and economic conditions. Among other considerations, it aims to improve the protection of animal health, the environment and the public health.

On 7 August 2023, Decree 405/2023 (“Decree”) was published to regulate Law No. 27,669 that states the regulatory framework for the development of the medicinal cannabis and industrial hemp industry. Further, the Decree: (i) regulates the chain of domestic production and commercialization and/or for export purposes of the cannabis plant, its seeds, and its derivative products for medicinal use, including scientific research and industrial use; and (ii) complements Law No. 27,350, which initially regulated the medical and scientific research of the medicinal use of the cannabis plant and its derivatives.

Last week the SEC published new proposed rules and amendments to address certain conflicts of interest associated with the use of Predictive Data Analytics by broker-dealers and investment advisers in interactions with investors. The wide-ranging proposal would require firms to implement detailed policies and procedures to identify and “eliminate or neutralize” the effects of such conflicts of interest.