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Product Regulation & Liability

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In Product Regulation & Liability

Italy: European Medicines Agency trials the package leaflet 2.0

by , and 1 Min Read

In July 2023 the European Medicines Agency, together with the network of the Heads of Medicines Agencies and the European Commission, started to work to in order to enable the use of the electronic product information, so called package leaflet 2.0. The package leaflet 2.0 consists of an electronic card that provides access to the information contained therein to the various telemedicine platforms; within that, the mandatory information on medicinal products, including the description of the product characteristics and the label, adapted for the electronic management, will be available.

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In Product Regulation & Liability

Singapore: Health Sciences Authority removes over 4,600 listings and seized more than 60,000 illegal health products as part of one-week international operation

by and 3 Mins Read

In October 2023, the Health Sciences Authority (HSA) participated in a one-week INTERPOL-led, internet-based operation involving 89 member countries targeting the sale of illegal health products.
The HSA announced that it removed over 4,600 listings of illegal health products from local e-commerce and social media platforms and seized more than 60,000 units of illegal health products at the Singapore Customs during a week of intensified surveillance from 3 to 10 October 2023.

In Product Regulation & Liability

United States: FTC reminds companies about need for influencer disclosures

by and 3 Mins Read

The United States Federal Trade Commission (FTC) has again shown that social media influencers, endorsements and testimonials remain an enforcement priority. The FTC sent warning letters to two trade associations and several dieticians and other online health influencers to make clear that failure to include clear disclosures that these are paid endorsements may violate the law.

In Product Regulation & Liability

Brazil: New state law creates the Consolidation of Consumer Protection Laws of the State of Sao Paulo

by 2 Mins Read

On 6 November 2023, State Law No. 17,832 of 1 November 2023 was published in the Official Gazette of the State of Sao Paulo, creating the “Consolidation of the State’s Consumer Protection Laws,” which aims to unify the main laws that protect consumer rights in the state, bringing them together in a single document to facilitate legislative consultation.

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In Environment

Global: Plastics regulation and what it means for the consumer goods and retail industry

by 2 Mins Read

Countries are approaching plastics regulation in different ways. Measures that have been proposed and adopted vary and include imposing plastic taxes, bans on single-use plastics, microbead bans, deposit return schemes, and consumer charges to discourage consumption (e.g., carrier bag charges). At an international level, in 2022, a UN resolution was endorsed to end plastic pollution and propose an international legally binding agreement by 2024.

In Product Regulation & Liability

United States: A Legal Makeover Guide for Complying with New Cosmetic Regulations under MoCRA (Part IV)

by 6 Mins Read

In the first three 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 (MoCRA), the good manufacturing practices regulations FDA plans to establish, as well as the FDA draft guidance on the facility registrations and products listings. In this Part IV, we are providing an important update of FDA’s compliance policy – enforcement discretion for MoCRA facility registration and product listing until 1 July 2024, as well as the existing FDA resources to help industry prepare for MoCRA implementation.

In Product Regulation & Liability

Spain: Green light to the use of QR codes in promotional materials aimed at healthcare professionals

by 3 Mins Read

The Ministry of Health has issued a note in which it promotes the use of QR codes to show the technical data sheet of medicinal products in promotional materials aimed at healthcare professionals. However, some information must remain in physical format to comply with the regulations on the advertising of medicinal products.

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Singapore: CSA announces launch of nine-month Cybersecurity Labelling Scheme for Medical Devices sandbox

by 3 Mins Read

On 20 October 2023, the Cyber Security Agency of Singapore, in collaboration with the Ministry of Health, Health Sciences Authority and national health technology agency, Synapxe, launched the Cybersecurity Labelling Scheme for Medical Devices sandbox. Medical device manufacturers are invited to participate in the sandbox to gain a first-mover advantage in enhancing the security of their products.

In Product Regulation & Liability

Singapore: HSA issues transition plan for compliance with the requirement for Evidence of Good Manufacturing Practice

by 3 Mins Read

On 29 September 2023, the Health Sciences Authority rolled out a one-year transition plan for companies to fully comply with the requirement for chemical drug substance manufacturers to provide Evidence of Good Manufacturing Practice Compliance. The HSA also provided clarity over the types of evidence that companies can submit as proof of GMP compliance.

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