Search for:
Category

Product Regulation & Liability

Category
In Product Regulation & Liability

Vietnam: New Law on Protection of Consumers’ Rights, new obligations for digital services providers

by , , and 10 Mins Read

On 20 June 2023, the National Assembly (NA) passed the Law on Protection of Consumers’’ Rights (amended), with an effective date of 1 July 2024, superseding the current Law on the Protection of Consumers’’ Rights No. 59/2010/QH12.

The New LPCR includes seven Chapters and 80 articles under which many proposed critical changes have been officially adopted. This law also addresses various issues that will have direct impacts on onshore and offshore organizations that transact or do business with consumers in Vietnam.

Read More
In Product Regulation & Liability

Italy: Ministerial decrees on clinical investigation applications published in the Official Journal

by 2 Mins Read

In the Official Journal of 13 June 2023, the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for devices that are not CE-marked and CE-marked but used outside their intended use and the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for CE-marked devices used within their intended use were published. These decrees are provided for in article 16, paragraphs 2 and 3 of Legislative Decree No. 137/2022 issued to bring national legislation in compliance with the provisions of Regulation (EU) 2017/745.

In Product Regulation & Liability

Italy: European Medicines Agency has updated its Q&A on good clinical practice (GCP)

by 2 Mins Read

On 23 June 2023, EMA’s GCP Inspectors Working Group updated the Q&A on Good Clinical Practices. In particular, the update has allowed for the possibility, if in compliance with applicable European regulations and the requirements of ICH E6 guideline, that the sponsor may support the investigator by identifying or contracting service providers or personnel to be directly involved in the conduct of the clinical trial (e.g., by providing additional resources to the clinical trial site or qualified personnel).

In Product Regulation & Liability

Italy: Decrees of the Ministry of Health of 20 March 2023 published in the Official Journal

by 2 Mins Read

In the Official Gazette of 14 June 2023, the Decree of the Ministry of Health of 20 March 2023 regulating the requirements of facilities suitable for conducting clinical investigations and the Decree of the Ministry of Health of 20 March 2023 introducing provisions to ensure that persons in charge of evaluating and validating clinical investigation applications do not have a conflict of interest, are independent of the sponsor, the investigators involved and the natural or legal persons financing the clinical investigation, and are free from any undue influence were published. These decrees, which are immediately applicable, are provided for in article 16, paragraphs 5 and 8 of Legislative Decree No. 137/2022.

In Product Regulation & Liability

United States: Complying with new cosmetic regulations under MoCRA (Part II)

by , and 8 Mins Read

In the first part of this series, A Legal Makeover Guide for Complying with New Cosmetic Regulations under the Modernization of Cosmetic Regulation Act of 2022 (MoCRA) Part I, we provided an overview of the new US Food and Drug Administration (FDA) ‘s regulatory requirements for cosmetics and their implementation deadlines. In this second part, we will delve into the details and look at the good manufacturing practices regulations the FDA plans to establish for cosmetic products.

Load More