Product Regulation & Liability Archives

In Europe

United Kingdom and European Union: Separate product safety reform initiatives continue with no guarantee of alignment

January 1, 2022 by John Leadley, Kate Corby and Joanne Redmond 9 Mins Read

The UK Office for Product Safety and Standards (OPSS) has published its response to the recent call for evidence on product safety in the UK (“Response”). In line with the government’s aim to capitalise on Brexit opportunities, the Response emphasises that the UK now has a genuine opportunity to “think boldly” about how to regulate product safety. One concern that is not addressed in detail in the Response is the risk that divergence from the EU product safety and regulatory regime could actually make the UK less attractive for business and in fact discourage innovation within the UK.

In Asia-Pacific

China: New Regulatory Requirements for Imported Food Products

December 30, 2021 by Frank Pan and Tina P. Li 8 Mins Read

On 12 April 2021, the General Administration of Customs of China issued Order No. 248, which sets out new requirements for the registration of qualified foreign food producers that are allowed to export food products to China, effective from 1 January 2022. This Order represents a significant move toward tightening up the regulation of foreign made food products imported into China.

In Cybersecurity, Data and Tech

Life Sciences Business Evolution Series – Report 1: How Digital Transformation and Data Are Shaping Business Models

December 23, 2021 by María (Vanina) Vanina Caniza, Henrique Kruger Frizzo, Elisabeth White, Randall Sunberg, Adam Aft, Anne Petterd, Hiroshi J. Sheraton, Julia M. Wilson and Khelin N. Aiken 2 Mins Read

As digital transformation reshapes business models with different emphases across regions, digitally enabled strategies are helping companies transition from product-only offerings to product-service hybrids, orient to patient mapping, pre-diagnostics solutions and enhancing treatment administration.

In ESG

Healthcare & Life Sciences Supply Chain Series: Integrating the healthcare & life sciences supply chain

December 23, 2021 by Cecilia Pastor, Kerry Contini, Mattias Hedwall, Adriana Ibarra-Fernandez and Anne Petterd 3 Mins Read

A helicopter view of each stage of the healthcare & life sciences supply chain lifecycle and an overview of the trends that businesses in the sector should consider in 2021 and beyond, including sustainability, digitalization and increased public funding.

In Europe

Italy: New document on relabeling and repackaging of medical devices

December 15, 2021 by Baker McKenzie 2 Mins Read

On October 21, 2021, the MDCG published a new question and answer document on the procedures governing the relabeling and repackaging of medical devices under Article 16 of the MDR and IVMDR.

In Europe

Italy: AIFA – new simplified negotiation procedures

December 15, 2021 by Baker McKenzie 3 Mins Read

On November 25, 2021, the AIFA published two new simplified negotiation procedures for (i) the negotiation of generic or biosimilar drugs and reimbursement applications for the extension of indications already reimbursed for the originator, and (ii) the reimbursement of new packages for changes in the primary packaging.

In Europe

Italy: Consolidated Law on rare diseases

December 15, 2021 by Baker McKenzie 2 Mins Read

On 27 November 2021, Law No. 175/2021 (“Consolidated Law”) was published in the Official Journal. The Consolidated Law’s main objective is the protection of the right to health of those suffering from rare diseases through measures aimed at ensuring the uniform distribution of services and medicines, including orphan drugs, throughout the Italian territory, the surveillance, diagnosis and treatment of rare diseases as well as the support to research activities.

In Europe

Italy: Medical device coordination group: Update of the document on the operating procedures of notified bodies

December 14, 2021 by Baker McKenzie 1 Min Read

In October 2021, the Medical Device Coordination Group (MDCG) published the third revision of the MDCG 2019-6 Questions and answers: Requirements relating to notified bodies, which provides clarification on the operating procedures of notified bodies responsible for performing conformity assessment activities under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

In Asia-Pacific

Thailand: Cannabis and hemp regulations – What it means for foreign investors and the private sector

December 14, 2021 by Peerapan Tungsuwan, Panyavith (Taro) Preechabhan, Prim Uditananda and Parisa Nontasirichayakul 5 Mins Read

In a recent interview Mr. Anutin Charnvirakul, the Minister of Public Health, lauded the many community enterprises all over Thailand which have been growing cannabis for hospitals to extract for medical purposes and the hundreds of medical cannabis clinics all over the country which have proven to be very popular with the Thai people. The Minister was pleased with how Thai people have embraced cannabis and has again stressed his mission to make cannabis both a cash crop, as well as a medicine, for the nation. He also mentioned intended efforts to continue with liberalizing the laws and regulations on cannabis even further to increase access to cannabis.

In Asia-Pacific

Thailand: The Narcotics Code will be effective on 10 December 2021

December 13, 2021 by Peerapan Tungsuwan, Panyavith (Taro) Preechabhan, Prim Uditananda and Parisa Nontasirichayakul 2 Mins Read

In the current narcotics and psychotropic substances regulatory regime, there are numerous laws governing narcotics and psychotropic substances which are enforced by different regulatory bodies. The Thai government aims to modernize certain current provisions and to incorporate these laws into the Narcotics Code for ease of reference and consistency in law enforcement.