The Spanish legal framework on packaging and packaging waste that entered into force in December 2022 substantially modified the regulation of packaging and packaging waste in an effort to implement a circular economy in Spain. Most of the obligations have already entered into force. However, certain marking and information obligations will enter into force on 1 January 2025.
On 13 September 2024, the Australian Government opened public consultation on the proposed Scams Prevention Framework. The Scams Prevention Framework introduces economy-wide reforms designed to combat scams and enhance consumer protections across multiple sectors including banking, telecommunications and digital platform services. Under the proposed regime, regulated entities in designated sectors will be required to take positive steps to detect, prevent and disrupt scams, with significant civil penalties for non-compliance.
The deadline for renewing the drug product registration license is approaching. All renewals must be submitted by 12 October 2024
On 21 August 2024, the Italian Medicine Agency issued the Guidelines on the matter of Regulatory Simplification and Decentralization for the Purpose of Conducting Clinical Trials of Medicinal Products in Accordance with Regulation (EU) No. 536/2014.
With determination No. 425 of 8 August 2024, the Italian Medicine Agency approved the new Guidelines for the Classification and Conduct of Observational Studies, implementing the provisions of Article 6(3) of the Ministerial Decree dated 30 November 2021.
The Medical Devices Cluster of the Health Sciences Authority has released a draft guidance on the Change Management Program for Software as a Medical Device. Change Management Program is the new optional regulatory pathway that aims to streamline the SaMD regulatory framework and facilitate timely implementation of software changes for registered SaMDs in Singapore.
The Ministry of Health commenced an investigation into a clinic offering telemedicine services for its allegedly clinically and ethically inappropriate practices. The Ministry of Health has stated that this is a likely breach of the Healthcare Services Act 2020. The medical practitioners engaged by the clinic are also being investigated for breach of the Singapore Medical Council’s Ethical Code and Ethical Guidelines.
On 18 September 2024, the Ministry of Economy, together with the Ministry of Energy published in the Federal Official Gazette the Directive that amends and establishes the products subject to regulation by SENER regarding their import and export.
The new Tobacco Products Law and the revised Tobacco Products Ordinance entered into force on 1 October 2024. The new legislation introduces important amendments to the current law. In particular, these relate to the regulation of electronic cigarettes, tobacco products for heating and tobacco products for oral use. Moreover, further measures for the protection of children and young adults have been introduced.
On 26 July 2024, the government of Indonesia issued Government Regulation No. 28 of 2024 (“GR 28”), which is an implementing regulation of Law No. 17 of 2023 on Health (“Health Omnibus Law”). GR 28 came into effect on the same day it was issued.
Through GR 28, the government aims to impose control by setting up limits on the maximum content level of sugar, salt and fat (known as gula, garam dan lemak/”GGL”) in processed food products.