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In Product Regulation & Liability

Spain: New deadline for transferring Medical Device Commercialization Communications to the CCPS application.

by 4 Mins Read

The PMPS, in which commercial communications of medical devices were registered, ceased to be operational and was replaced by the new CCPS application of the AEMPS. However, communications made to the PMPS were still valid, although they cannot be managed until they are migrated to the CCPS. Consequently, the AEMPS has set the deadline of 18 July 2023 for the transfer of marketing communications to the new CCPS application, requesting companies to retrieve them by that date, updating their information and submitting them to the necessary review by the AEMPS, prior to their inclusion in CCPS.

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In Product Regulation & Liability

EU: New developments in breeding products, animal health and traceability requirements

by 4 Mins Read

The new Delegated Regulation (EU) 2023/647 has amended the former Delegated Regulation (EU) 2020/686, which in turn complemented Regulation (EU) 2016/429, on the prevention and control of transmissible animal diseases, animal health requirements and traceability of animal reproductive products. The new Regulation complements the rules laid down in the original regulation as regards animal health issues of traceability and certification of movements of captive breeding products of terrestrial animals. Furthermore, the main objective of the regulation is to unify the different regulations applicable on this matter in order to improve their application and to avoid duplication or cross-references.

In Product Regulation & Liability

Spain: New indications from the AEMPS on the adaptation of veterinary medicinal products to European Regulation

by 4 Mins Read

The AEMPS has published new indications on the adaptation of veterinary medicinal products to the content of Regulation (EU) 2019/6, which establishes a period of five years for veterinary medicinal products authorized under the previous legislation to adapt to the provisions of the new Regulation. For this reason, the Quality Review of Documents has been adapted to version 9.0 on the summaries of product characteristics, package leaflet and labelling of veterinary medicinal products.

In AML & Financial Services Regulatory

UAE: Securities and Commodities Authority issues new regulations relevant to virtual assets

by 2 Mins Read

The United Arab Emirates’ federal-level financial services regulator relevant to securities, commodities and now Virtual Assets Service Providers, the UAE Securities and Commodities Authority (SCA), has just issued two new regulations relevant to Virtual Assets:
1. SCA Chairman of the Board of Directors’ Decision No. (26/RM) of 2023 in relation to Virtual Assets Platform Operators
2. SCA Chairman of the Board of Directors’ Decision No. (27/RM) of 2023 amending SCA Chairman of the Board of Directors’ Decision No. (13/RM) of 2021 in relation to the SCA Rulebook

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In AML & Financial Services Regulatory

Argentina: General Resolution No. 959/2023

by 4 Mins Read

On 2 May 2023, the Argentine Securities and Exchange Commission issued General Resolution No. 959/2023 in order to restrict the sale of marketable securities with settlement in foreign currency for parties that hold positions in surety bonds and/or repos, regardless of the settlement currency. Likewise, settlement and clearing agents are prohibited from granting financing to the transactions mentioned above. Finally, the term of permanence in portfolio for the sale of marketable securities with settlement in foreign currency in foreign jurisdiction is modified.

In Corporate Compliance

International: Assess, visualize and improve the effectiveness of your compliance program

by , , , , , , and 1 Min Read

Most major companies have implemented a compliance program but often struggle with two issues: ensuring the compliance program remains effective in light of their existing and changing landscape and making it more efficient by leveraging technology. The Compliance Cockpit specifically addresses both issues.

In AML & Financial Services Regulatory

Argentina: Communication “A” 7759 on Payment Service Providers and Crypto-assets

by 1 Min Read

On 4 May 2023, the Argentine Central Bank (ACB) issued Communication “A” 7759, whereby it amended the regulations applicable to Payment Service Providers Offering Payment Accounts (PSP). Under the Communication, the ACB established that PSPs shall not carry out or facilitate transactions involving digital assets (including crypto-assets) for their clients.

In AML & Financial Services Regulatory

Mexico: Bill of Law prohibiting suppliers of goods, products or services from charging additional fees for using debit or credit cards

by 1 Min Read

On 20 April 2023, a bill of law was published, approval pending, to amend the Federal Consumer Protection Law to prohibit suppliers of goods, products or services from charging a commission or additional fee to consumers when they use a debit or credit card as a payment method instead of cash. The foregoing is motivated by the fact that this practice of some suppliers is detrimental to the consumers’ economy and discourages the use of debit or credit cards as a payment method.

In Sanctions

Canada Proposes Amendments to Economic Sanctions Framework and Seeks to Establish Deemed Ownership Provisions

by 11 Mins Read

The Government of Canada recently introduced Part 1 of the budget implementation bill, which completed its second reading before the House of Commons and has been referred to the Standing Committee on Finance. The Bill proposes novel amendments, including “deemed ownership” provisions to the Special Economic Measures Act and the Justice for Victims of Corrupt Foreign Officials Act and it demonstrates that the Government intends to rely on existing anti-money laundering enforcement regimes to eliminate sanctions circumvention and enforce sanctions compliance. Additionally, the Bill seeks to expand the Government’s authority to prohibit activities with specific persons under the SEMA.

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