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In AML & Financial Services Regulatory

Indonesia: Things to watch in financial conglomeration and consolidation

by , , , , and 4 Mins Read

This is the fourth in a series of client alerts in relation to Law No. 4 of 2023 on the Development and Strengthening of the Financial Sector (“P2SK Law”), dated 12 January 2023. Aside from asserting the provisions that have been stipulated by the Financial Service Authority, the P2SK Law sets out several new provisions that open a new chapter in the financial conglomeration and consolidation. The P2SK Law now requires financial conglomerates to establish or appoint a financial holding company, a legal entity that is expected to control, consolidate and be responsible for all of the financial conglomerate’s activities. The P2SK Law also affirms OJK’s authority to give written orders to financial services companies to push for financial consolidation.

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In AML & Financial Services Regulatory

South Africa: Crypto asset advertisements now regulated

by and 4 Mins Read

Crypto asset advertisers should be aware that they must now comply with new regulatory requirements around the publishing of crypt asset advertisements in South Africa. The South African Advertising Regulatory Board’s Code of Advertising Practice was broadened to include new requirements for crypto assets in January 2023. Crypto asset advertisers should prioritize compliance with new requirements under the ARB Code because, although the ARB’s rulings are not binding, an adverse decision is usually accepted by the advertising and publishing community and can result in reputational consequences for advertisers.

In White Collar Crime

Indonesia: New Criminal Code – fraudulent acts against creditors chapter

by , , and 4 Mins Read

The New Criminal Code became the first piece of legislation passed into Law in 2023 and was promulgated on 2 January as Law No. 1 of 2023. This alert takes a look at how the New Criminal Code reintroduces crimes related to fraudulent acts against creditors. In the absence of any criminal provisions under Law No. 37 of 2004 on Bankruptcy and Debt Suspension of Payment, any criminal sanctions for fraudulent-related acts against creditors are those originally set out in the old criminal code. The New Criminal Code reinvents the provisions in the old criminal code and reintroduces them as a new section in the fraudulent-related acts against creditors.

In Product Regulation & Liability

United States: FDA – Zeroing in on lead in food for babies and young children

by , and 3 Mins Read

On 24 January 2023, the US Food and Drug Administration issued draft guidance on action levels for lead in certain categories of processed foods intended for babies and children under two years of age. These action levels reflect levels of lead at which FDA may regard the food as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug & Cosmetic Act. FDA will consider these action levels when determining whether to bring an enforcement action.

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In Product Regulation & Liability

European Union: Recommendations for the conduct of decentralized clinical trials

by and 2 Mins Read

On 19 December 2022, the Recommendation Paper on Decentralized Elements in Clinical Trials was published on the website of the European Medicines Agency, with the aim to facilitate the conduct of decentralized clinical trials in the EU, while safeguarding the rights and well-being of participants and the robustness and reliability of the data collected.

In Product Regulation & Liability

European Union: Clinical trials information system becomes mandatory

by and 1 Min Read

Starting from 31 January 2023, the Clinical Trial Information System, provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area countries. The single portal was launched on 31 January 2022, initiating the one-year transition period during which sponsors could choose whether to submit a clinical trial application according to the Clinical Trials Directive or through the single portal. As of 31 January 2023, submission of clinical trial applications through the single portal will become mandatory.

In Product Regulation & Liability

Singapore: HSA update on products found by overseas regulators to contain potent ingredients

by and 2 Mins Read

On 3 January 2023, the Health Sciences Authority (HSA) issued an update on products found and reported by overseas regulators to contain potent ingredients that are prohibited and may cause side effects. The HSA published a consolidated list of health products that were found and reported by health regulators overseas (including regulators in Brunei, Canada and Hong Kong) to contain potent ingredients.

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In Environment

Brazil: State decree establishes take-back requirements system for packaging in Mato Grosso do Sul

by , , and 2 Mins Read

On 17 January 2023, State Decree nº 16,089/20231 was published, establishing and updating the take-back requirements system for packaging in the state of Mato Grosso do Sul. In summary, the decree becomes the new regulatory standard on the take-back requirements system for packaging in the state.

In Product Regulation & Liability

Italy: AIFA updates Active Substance Master File submission procedures

by and 1 Min Read

On 23 December 2022, the Italian Medicines Agency (AIFA) published on its website an update concerning the procedures for submitting the Active Substance Master File, which is the document that the manufacturer of the active ingredient is required to submit to AIFA for the active substances contained in the medicine for which a marketing authorization has been applied for.

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