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Luxembourg's first dip before surfing on the blockchain wave

On 14 February 2019, the Luxembourg Parliament adopted the bill (the "Bill")(*) amending the law dated 1 August 2001 on the circulation of securities (the "Securities Law").

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Hogan Lovells Publications

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level...

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What lies ahead for UK payments and retail banking regulation in 2019?

2018 was dominated by preparations, or talk about preparations, for Brexit and 2019 started out in the same vein, with many firms planning for the worst while hoping for the best.

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Card acquiring services: UK Payment Systems Regulator launches its market review

The UK Payment Systems Regulator (PSR) has kicked off its market review into card-acquiring services with the publication of its final terms of reference (ToR). For affected firms,...

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Hogan Lovells Publications

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will take to ensure that the Orange Book (FDA's publication of Approved Drug...

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South Africa's green rush- "weeding" out the confusion

Following the recent landmark decision of the South African Constitutional Court, in which the private and personal use of cannabis was decriminalised, together with the publication of...

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Africa 2019 – The Optimist's View

Andrew Skipper, head of Africa for Hogan Lovells, looks forward to Africa’s business and investment climate for 2019.

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The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases

On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines...

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Hogan Lovells Publications

Pharma companies may benefit from proposed patent law changes in China; public comment invited

On 4 January, China's National People's Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to...

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FCA finalised guidance on fairness of variation terms in financial services consumer contracts: the devil's in the detail

The FCA published their finalised guidance on the fairness of variation terms in financial services consumer contracts under the Consumer Rights Act 2015 on 19 December 2018.

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