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Articles by Louise Strom
New 2021 Code Of Practice For The British Pharmaceutical Industry
United States: New 2021 Code Of Practice For The British Pharmaceutical Industry 27 January 2021 by Adela Williams , Louise Strom and Daisy Bray Arnold & Porter Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com.
New 2021 Code of Practice for the British Pharmaceutical Industry
The UK’s Association of the British Pharmaceutical Industry (ABPI) has, together with the Prescription Medicines Code of Practice Authority (PMCPA), published the new Code of Practice for the Pharmaceutical Industry (the 2021 Code). Publication of the 2021 Code follows a consultation conducted in 2020, with subsequent revisions prior to approval on 12 January 2021. The 2021 Code will be implemented from 1 July 2021 and represents a significant structural revision of the current 2019 Code.
EU Medical Devices Regulation: Adoption Of Further Guidance Documents
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EU Medical Devices Regulation: Adoption of further guidance documents
In this post, updating our series of posts on the implementation of the EU Medical Devices Regulation (MDR), we take a look at the latest steps taken by the EU institutions to ensure the MDR is fully applicable by May 2021.
An Overview Of EU Rules On Consumer Advertising Of Over-The-Counter Products In The Life Sciences Sector
To print this article, all you need is to be registered or login on Mondaq.com. 1. Introduction Commentary on EU life science advertising regulation frequently focuses on the rules applicable to advertisements for prescription products directed to healthcare professionals. Less is written about other types of products that form part of the EU healthcare market, and the advertising restrictions that exist in relation to the marketing of these products to consumers.
EU Medical Devices Regulation: Implementation Progress During The Pandemic
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EU Medical Devices Regulation: implementation progress during the pandemic
Although the date of application of the Medical Devices Regulation (MDR) has been delayed by a year, to May 2021, the EU institutions continue to work on its implementation to ensure that the new framework is workable in time for the revised deadline. In this post, which is part of our series of blog posts covering the implementation of the MDR, we set out a summary of key recent developments.
EU MDR Implementation: New Guidance And Implications Of The Deferral
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EU MDR implementation: new guidance and implications of the deferral
As part of our series of blog posts covering the implementation of the EU Medical Devices Regulation (MDR), we comment below on the latest developments, including the deferred application of the MDR and the most recent guidance issued by the European Commission’s medical device coordination group (MDCG). Deferral of the MDR This is the month when it was all due to happen: after years of planning and preparing, the MDR was finally due to take effect on 26 May 2020.
Two Months To Go: Latest On The Implementation Of EU MDR (Part 1)
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Stop Press! Possible Delay To The EU MDR
Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice): Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below. Mondaq has a "free to view" business model.
Two Months To Go: Latest On Implementation Of EU MDR (Part 2)
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Two months to go: Latest on implementation of EU MDR (Part 2)
With only two months to go before the date of application of the Medical Devices Regulation (MDR) on 26 May 2020, the Commission has taken various steps towards its implementation. As we have discussed, while there are lots of good intentions, there is still much to be done – although it now seems that a delay to the May date is on the horizon. Last week, the MDCG published a number of guidance documents providing much needed clarity on some of the “priority” areas.
STOP PRESS! Possible delay to the EU MDR
As set out in our previous post, it is two months until the (current) date of application of the Medical Devices Regulation (MDR) on 26 May 2020. In this series of posts, we wanted to update you on the state of implementation given the fast-approaching deadline. However, as we were speculating that the current timeframe was looking increasingly untenable, the Commission announced yesterday (25 March) that it was working on a proposal to postpone the date of application by a year.
Two months to go: Latest on the implementation of EU MDR (Part 1)
There are now only two months to go before the date of application of the Medical Devices Regulation (MDR) on 26 May 2020. We have previously published updates on various implementation activities, and the concerns of industry and stakeholders that the deadline has been fast approaching but that there remains a huge amount to be finalised. The difficulties surrounding Brexit, and now the coronavirus pandemic, only add to these concerns.
UK Government Publishes New Draft Legislation On Medicines And Medical Devices
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UK government publishes new draft legislation on medicines and medical devices
The UK government published its Medicines and Medical Devices Bill (the Bill) on 13 February 2020. The Bill seeks to introduce delegated powers which will allow the Secretary of State to amend or supplement the existing UK regulatory framework for medicines, medical devices, clinical trials and veterinary medicines at the end of the transition period for the UK’s departure from the EU (the Transition Period), which is currently scheduled for 31 December 2020.
Latest View On Health Claims On Foods In The EU
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Healthcare enforcement and litigation in United Kingdom | Lexology
Overview Healthcare funding In general terms, how is healthcare, including access to medicines and medical devices, funded in your jurisdiction? Outline the roles of the public and private sectors. The UK’s healthcare system comprises of services that are both publicly and privately funded.
Enforcement of pharmaceutical product and medical device regulations in United Kingdom | Lexology
Regulation of pharmaceutical products and medical devices Monitoring powers What powers do the authorities have to monitor compliance with the rules on drugs and devices? The MHRA has similar investigatory powers for both medicines and devices.
Private enforcement of healthcare laws and regulations in United Kingdom | Lexology
Private enforcement Causes of action What private causes of action may citizens or other private bodies bring to enforce a healthcare regulation or law? Private causes of action to enforce healthcare laws typically involve claims of negligence or product liability. However, the main route for individuals or companies to seek enforcement of healthcare laws and regulations is by submitting a complaint to the relevant regulatory authority.
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