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On 31 January 2024, the Italian Medicines Agency (AIFA) published the Guidelines on applications for marketing authorizations submitted through the national procedure. The purpose of the Guidelines is to provide detailed information about (i) the correct submission of applications for marketing authorization and the relevant administrative and technical documentation, (ii) the steps and timeframes for the AIFA’s assessment of such applications, including any requests for clarification and/or further documentation, and (iii) the publication of the results of the preliminary assessment, the procedures for issuing the final resolutions as well as for their notification and publication in the Official Gazette.

On 23 January 2024, the European Medicines Agency published an updated version of the user guide for micro, small and medium-sized enterprises in the pharmaceutical sector. The revised guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorization of medicines for human and veterinary use.

With Decree of 29 December 2023, published on 9 February 2024, the Ministry of Health identified the criteria and procedures for the payment of the annual fees for the monitoring and management of the Fund for the Governance of Medical Devices referred to in Article 28 of Legislative Decree No. 137/2022.

On 30 January 2024, the Health Science Authority (HSA) announced it had seized over 1.12 million units of illegal health products and removed over 12,000 listings of illegal health products from local e-commerce and social media platforms in 2023 through targeted operations, intelligence sharing and joint enforcement efforts with local and overseas agencies.
Illegal health products include unregistered or counterfeit health products, as well as products with potent medicinal ingredients or banned substances illegally added to them.

On 23 January 2024, the European Commission published a proposal to amend Regulation 2017/745 (EU) on Medical Devices and Regulation (MDR) 2017/746 (EU) on In Vitro Diagnostic Medical Devices (IVDR), which regulate notification requirements in the event of an interruption in the supply of certain types of medical devices and in vitro diagnostic medical devices, the introduction of Eudamed as a tool for the diffusion of information on devices available on the EU market, as well as transitional provisions for in vitro diagnostic medical devices.

In order to set the regulatory framework for a products containing cannabis, the Ministry of Health has launched a public consultation on a draft Royal Decree establishing the conditions for the preparation and dispensing of magistral formula based on standardized preparations of these substances. In this regard, the interested parties were able to present allegations until 4 March 2024.

To future-proof its regulatory system, the UAE cabinet has established the Emirates Drug Corporation (EDC) in September 2023. As a new independent regulator, the EDC will replace the Ministry of Health and Prevention for the regulation of pharmaceuticals and medical devices.

Besides medicines and medical devices the EDC will also be responsible for cosmetics, dietary supplements, GMOs, fertilizers, pesticides, agricultural conditioners and plant growth regulators. The EDC will also take over some competences from the Ministry of Climate Change and Environment in relation to these products.

Investigations are an essential tool for ensuring a company’s ethical standards are being followed by employees, business partners, and any others with whom the company interacts. However, investigations are also an essential tool for demonstrating and maintaining strong corporate governance – an integral part of a company’s ESG commitments and strategy. It is also a good time to set yourself some goals and resolutions. To help you on your way, we are pleased to share our top 5 Lunar New Year Resolutions for handling Internal or Government Investigations