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We have moved parts of our blog to the new technology platform Engage. Engage will give you the legal and regulatory insight and analysis you need, from across our global network, when you need it. If you are signed up to receive emails from us, you’ll soon receive an email with details on how to use Engage to continue to stay up-to-date on the latest developments in regulation, as well as on different topics published by the firm if you’d like.
The third amendment to the German State Treaty on Gaming (GlüStV) will come into force on 1 January 2020. Private operators of online sports betting platforms will now be given the opportunity to apply for a licence for the operating of online sports betting in Germany.
1. Introduction On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. This is part of MHRA’s continued effort to regulate medical devices in the event of a no-deal Brexit. With the possible withdrawal of the UK from
On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that address unmet medical needs. In addition to outlining the tools currently available to manufacturers seeking expedited approval of breakthrough
Foreign direct investment (“FDI”) screenings have become a relevant factor for global transactions in recent years. More and more jurisdictions are introducing or ramping up their powers for scrutinising FDI, which parties to M&A transactions and their advisors need to consider when structuring such deals and planning for completion of the projects. In Europe, the
The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques. The first Brexit related communique concerned changes to: data which was included within marketing permissions, data being made available on the market, and data concerning the use of biocidal products. The second
A Hogan Lovells study comparing of regulatory requirements in the European Union, United States, and China shows the complexity and uncertainty of the regulatory framework relevant to Internet of Things (IoT) in Europe. The number of telecoms regulatory constraints affecting IoT in the EU is almost twice as high as in the United States and
On 1 March 2019, the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the medical devices. It is announced that in the event of a “no-deal” Brexit, as from 30 March 2019, the United Kingdom
On 25 February 2019, the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event of a “no-deal” Brexit. In the event of a “no-deal” Brexit, the President of the Office has recommended that companies immediately introduce post-registration
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”). This Notice applies, among others, to medical devices, active implantable medical devices and in vitro medical devices. The Q&A
Introduction On 19 December 2018, the European Commission published a Communication addressed at the EU institutions. The Communication relates to the preparation for the withdrawal of the United Kingdom from the European Union, in case of a “no-deal” Brexit. The Communication discussed 14 measures that the European Commission has adopted to prepare for the “no-deal”
The President of the Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) estimates that approximately 20% of all the 10,000 medicinal products registered in Poland will be affected by the effects of Brexit. Out of this number, according to media reports, new reimbursement decisions will need to be issued for
Notwithstanding the fact that a draft deal has been agreed between the EU and the UK at a technical level, the developments of recent days and weeks have made it clear that significant obstacles will need to be overcome before any deal can be finalised and ratified. In light of this uncertainty, there remains a
The UK Department of Health and Social Care (DHSC) has published a new policy paper “The future of healthcare: our vision for digital, data and technology in health and care” setting out the UK’s approach to using the best technology available in the National Health Service (NHS) and social care sector to provide better care
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be amended in the event of a “no deal” scenario, i.e. if the UK leaves the EU on 29 March 2019 without the framework
In the final batch of technical notices, the UK Government has provided guidance on what impact traders can expect on food labelling and packaging in the event that the UK exits the EU without a Withdrawal Agreement on 29 March 2019. Producing and labelling food Currently, EU rules, such as EU Regulation 1169/2011 or “FIC”,
The UK Government has released a further batch of technical notices, providing guidance to businesses on the implications of an exit from the EU without a Withdrawal Agreement on 29 Mach 2019. Three of these notices will be of particular interest to businesses trading goods in other EU Member States: 1. Trading under the mutual
On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their joint task force regarding the availability of authorised medicines for human and veterinary use. The HMA-EMA task force was created
The Government has released its first batch of technical notices which aim to prepare UK citizens and businesses for an exit from the EU without a Withdrawal Agreement on 29 March 2019. Of most relevance to food businesses are the notices on developing genetically modified organisms (“GMOs“) and producing and processing organic foods. Under the
The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. If the draft Withdrawal Agreement is finalised by the UK and EU, during the implementation period the UK will no longer be an EU Member
On 19 June 2018, the European Medicines Agency (EMA) published updates to its Brexit Q&A document for human and veterinary medicines authorised via the centralised procedure and to its practical procedural guidance on making Brexit related changes to the authorisations for those products. The updated version (“Rev 03”) of the EMA Q&A document includes new
On 4 June 2018, the European Commission adopted a proposal for a Regulation to modify existing EU rules to allow manufacturers of vehicles to obtain new approvals from the 27 EU Member States who will remain post-Brexit to replace their existing UK-type approvals. Although the proposed Regulation focuses specifically on vehicles it could be interpreted
The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit: medicines, medical devices and substance of human origin”, which considered the regulatory arrangements needed for the safe and effective supply of medicines and medical devices post-Brexit (see our blog