In April, Royal Decree-Law 7 of 27 April 2021 was passed. It introduced major amendments to Royal Legislative Decree 1 of 16 November 2007, approving the revised text of the General Consumer and User Protection Act and other supplementary acts, which we analysed in our May newsletter.
Following the recent publication of the UK Hydrogen Strategy, the UK Government has now published its Net Zero Strategy. As expected, low carbon hydrogen development is central to this strategy. At the core of the strategy is an ambitious goal of fully decarbonizing UK power systems by 2035.
In October 2021, the Medical Device Coordination Group published the Guidance on the classification of medical devices. In particular, the purpose of the Guidance is to ensure the proper application of the classification rules set forth in Annex VIII to the Medical Device Regulation (EU) 2017/745 (MDR).
On 28 October, Baker McKenzie International Human Rights lawyer was joined for a conversation with Canada’s first Ombudsperson for Responsible Enterprise Sheri Meyerhoffer, to explore the mandate of the Office of the Canadian Ombudsperson for Responsible Enterprise.
On 28 September 2021, the European Commission launched a public consultation on the proposed revision of the current EU’s general legislation on medicines for human use referred to in Directive 2001/83/EC and Regulation 726/2004 in order to ensure a future-proof and crisis-resistant medicines regulatory system.
Please join us for upcoming webinars on important developments in the Consumer Goods & Retail industry. Please note that the webinar series will be held in German only
The National Institute of Pharmacy and Nutrition (“OGYÉI”) issued a Guidance on 20 September which contains useful information on the OGYÉI’s interpretation of the recent legislative amendments of Act XCVIII of 2006 concerning medicine promotion, events and contracts with HCPs.
The Medical Device Coordination Group (MDCG), the expert panel of the EU Member States and the EU Commission, has released on 20 October 2021 two guidance documents which provide meaningful guidance (1) for manufacturers, importers and distributors of “legacy devices” on which MDR obligations they must comply with (guidance document 2021-25), and (2) on the obligations of parallel importers regarding the repackaging and relabeling of medical devices under Article 16 MDR/IVDR (guidance document 2021-26).
Last June, the Superior Court of Justice of the Basque Country delivered a decision with wide repercussion with regards to advertising of medicinal products by pharmaceutical companies. The decision ruled on an appeal filed by Farmaindustria (the Spanish trade association bringing together innovative pharmaceutical companies) against a regional Order regulating the advertising of pharmaceutical products through medical sales representatives in the context of the Basque Health System.
Join the regulatory affairs specialists in our Bangkok office’s Healthcare & Life Sciences Industry Group at this insightful webinar to get an overview of the key issues which you should consider when undertaking a regulatory compliance audit as applicable to pharmaceuticals, medical devices, foods and cosmetics (including considerations based on recent legal updates), as well as the steps that may be taken to ensure you stay compliant and avoid unnecessary pitfalls.