Navigating Market Authorisation in the UK for the pharmaceutical industry – 3PB

Posted June 18th, 2020 in health, licensing, medicines, news by sally

‘‘Marketing Authorisation’ must be obtained in respect of any medicinal product that is to be sold, supplied or offered for sale or supply in the UK. This article looks at the different types of authorisation available, including when they might be appropriate for use in respect of the UK only before considering the process adopted in the UK for approving medicines into the market. It is designed to be a beginner’s guide to bringing new products to market in the UK as opposed to a full explanation of each step; ultimately how the application itself is make will depend on the product itself and the research behind it. If upon reading this article you gain an understanding of how to begin the Market Authorisation process, then this article has served its purpose.’

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3PB, 4th June 2020

Source: www.3pb.co.uk

BAILII : Recent Decisions

Posted June 18th, 2020 in law reports by sally

Supreme Court

Bresco Electrical Services Ltd v Michael J Lonsdale (Electrical) Ltd [2020] UKSC 25 (17 June 2020)

Sainsbury’s Supermarkets Ltd v Visa Europe Services LLC & Ors [2020] UKSC 24 (17 June 2020)

Court of Appeal (Civil Division)

B And Y, Re [2020] EWCA Civ 767 (17 June 2020)

Court of Appeal (Criminal Division)

Waite v R. [2020] EWCA Crim 768 (17 June 2020)

S, R. v [2020] EWCA Crim 765 (17 June 2020)

Jones, R v [2020] EWCA Crim 764 (12 June 2020)

High Court (Administrative Court)

Boyer, Review of the Tariff In the Case of [2020] EWHC 1560 (Admin) (17 June 2020)

Maczkowski v Circuit Court In Gdansk, Poland [2020] EWHC 1583 (Admin) (17 June 2020)

Brooks, Review of the Tariff In the Case of [2020] EWHC 1562 (Admin) (17 June 2020)

General Medical Council v Awan [2020] EWHC 1553 (Admin) (17 June 2020)

Lendrum v Brazil Judicial Authority [2020] EWHC 1570 (Admin) (16 June 2020)

Wood Boilers LLP & Anor v Gas and Electricity Markets Authority [2020] EWHC 1578 (Admin) (16 June 2020)

High Court (Commercial Court)

The London Steam-Ship Owners’ Mutual Insurance Association Ltd v Spain (M/T PRESTIGE)[2020] EWHC 1582 (Comm) (18 June 2020)

Public Joint Stock Company (Rosgosstrakh) v Starr Syndicate Ltd & Ors [2020] EWHC 1557 (Comm) (17 June 2020)

High Court (Family Division)

JK v LM [2020] EWHC 1566 (Fam) (17 June 2020)

High Court (Queen’s Bench Division)

XLD v KZL [2020] EWHC 1558 (QB) (17 June 2020)

Archer v The Commissioner of Police of the Metropolis [2020] EWHC 1567 (QB) (17 June 2020)

High Court (Technology and Construction Court)

Stagecoach East Midlands Trains Ltd & Ors v The Secretary of State for Transport [2020] EWHC 1568 (TCC) (17 June 2020)

Source: www.bailii.org

De Sena v Notaro [2020] EWHC 1031 (Ch): The family, the demerger and the expert who wasn’t an expert – Hailsham Chambers

‘The case arose out of a corporate demerger which took place in relation to a family owned company, S Notaro Holdings (“Holdings”), on 28 April 2011. The First Claimant (C1), and the First Defendant (D1) were siblings. Prior to the demerger, they were both shareholders in and directors of Holdings. Neither were majority shareholders. D1 held 43.75% of the shares in Holdings, and C1 held 31.25%. In the demerger, C1 gave up her shares in Holdings in exchange for some assets of Holdings or its subsidiaries being transferred to the Second Claimant (C2), a company formed for that purpose, owned and controlled by C1.’

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Hailsham Chambers, June 2020

Source: www.hailshamchambers.com

Lewis Graham: Lessons from Lord Hope’s Diaries: judicial ideology and panel selection – UK Constitutional Law Association

Posted June 18th, 2020 in judges, judiciary, news, Supreme Court by sally

‘Even in a more transparent and open Supreme Court, glimpses behind the curtain of officialdom are seldom offered to the public. This is understandable; the independence and impartiality of the judiciary sets it apart from other branches of the state. As Lord Neuberger (The Power of Judges, p.22) has noted, to be effective, “justice has always to be detached, almost Olympian”. We may know of judges in their official capacity, but once they adopt their robes, personal accounts of their day-to-day lives generally remain off-limits.’

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UK Constitutional Law Association, 18th June 2020

Source: ukconstitutionallaw.org

Government facing legal challenge over urgent award of £108m PPE contract – Local Government Lawyer

‘The Good Law Project will today [15 June] launch judicial review proceedings over the Government’s award of an £108m contract to a pest control company for the supply of PPE.’

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Local Government Lawyer, 15th June 2020

Source: www.localgovernmentlawyer.co.uk

Here’s what the Romans did for us, Court of Appeal explains – Litigation Futures

Posted June 18th, 2020 in animals, fisheries, news, receivers, sale of land by sally

‘The Court of Appeal has gone back to a Roman legal scholar from AD 161 to help determine who owned fish in a lake in Lancashire after it was sold.’

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Litigation Futures, 18th June 2020

Source: www.litigationfutures.com

Police in England and Wales taking ‘excessive personal data’ from mobile phones – The Guardian

‘Police are extracting “excessive amounts of personal data” from the mobile phones of victims and witnesses during investigations and are in danger of discouraging the public from reporting crime, the Information Commissioner’s Office (ICO) has warned.’

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The Guardian, 18th June 2020

Source: www.theguardian.com

Ending it all – duties under section 188 – Nearly Legal

‘Where a local authority has an initial s.188 Housing Act 1996 duty to provide interim accommodation, but then makes a s.184 decision that the applicant is not in priority need, is that sufficient to bring the s.188 duty to an end? In this judicial review, the answer turns out to be no, at least not if the s.189B duty is continuing and notice of no further duty has not been served.’

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Nearly Legal, 16th June 2020

Source: nearlylegal.co.uk

Tribunal strikes out “vexatious” claims against leading firm – Legal Futures

‘A former employee of national law firm Shoosmiths – who was awarded £1,000 in damages for harassment back in 2017 – has had a string of further claims thrown out, with an employment tribunal branding them vexatious.’

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Legal Futures, 18th June 2020

Source: www.legalfutures.co.uk

Novel foods regulation: Getting your product to the UK market – 3PB

Posted June 18th, 2020 in consumer protection, EC law, food, news, regulations by sally

‘Foods that fall within the definition of “novel food” must have market authorisation before they can be legally marketed in the UK. This article examines what novel foods are and the authorisation process to allow novel food products to reach the UK market. This article touches upon, but does not address at length, the process in respect of “traditional foods from third countries”.’

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3PB, 5th June 2020

Source: www.3pb.co.uk

Daughters’ psychiatric claims restored over witnessing of father’s death – Law Society’s Gazette

Posted June 18th, 2020 in causation, news, psychiatric damage, striking out, third parties by sally

‘The High Court has ruled it was wrong to strike out secondary victim claims from daughters who witnessed their father die after he was allegedly victim of clinical negligence.’

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Law Society's Gazette, 12th June 2020

Source: www.lawgazette.co.uk

Pet theft law change urged as cases go ‘through the roof’ in lockdown – BBC News

Posted June 18th, 2020 in animals, coronavirus, news, theft by sally

‘Campaigners have called on the government to make pet theft a specific offence after instances of the crime “went through the roof” in lockdown.’

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BBC News, 17th June 2020

Source: www.bbc.co.uk

Police in England and Wales dropping rape inquiries when victims refuse to hand in phones – The Guardian

‘Rape investigations are being systematically dropped after victims refuse to hand over their mobile phones for analysis, an investigation has found.’

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The Guardian, 17th June 2020

Source: www.theguardian.com

Commerzbank fined £38m by UK watchdog for money-laundering failings – The Guardian

Posted June 18th, 2020 in banking, financial regulation, fines, money laundering, news by sally

‘The UK’s financial regulator has fined Commerzbank £38m for money-laundering failures, including an “out-of-control” system for checking clients.’

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The Guardian, 17th June 2020

Source: www.theguardian.com

Court blocks new expert on disabled claimant’s life expectancy – Law Society’s Gazette

Posted June 17th, 2020 in damages, evidence, expert witnesses, insurance, news, personal injuries by sally

‘The High Court has refused an insurer permission to rely on a new expert whose evidence reduced the estimated life expectancy of a personal injury claimant.’

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Law Society's Gazette, 17th June 2020

Source: www.lawgazette.co.uk

Paul v Royal Wolverhampton NHS Trust [2020] EWHC 1415 (QB): A glimmer of hope for secondary victims? – St Philips Chambers

‘The law relating to secondary victims, who suffer psychiatric injury as a result of witnessing a shocking event, has long been an area of contention.’

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St Philips Chambers, 8th June 2020

Source: st-philips.com

EHRC reports on inclusive justice – UK Human Rights Blog

‘Ten years after the Equality Act came into force, the Equality and Human Rights Commission (EHRC) have published their findings and recommendations in a report entitled “Inclusive Justice: a system designed for all”. Although the report recognises where progress has been made, it also identifies very significant problems.’

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UK Human Rights Blog, 16th June 2020

Source: ukhumanrightsblog.com

Police in England and Wales six times more likely to fine BAME people in lockdown – The Guardian

‘Police enforcing the coronavirus lockdown in England and Wales were more than six times more likely to issue fines to black, Asian and minority ethnic people than white people, figures show.’

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The Guardian, 16th June 2020

Source: www.theguardian.com

Vulnerable parties and witnesses in employment tribunal proceedings – 12 King’s Bench Walk

‘The first Presidential Guidance on vulnerable parties and witnesses in employment tribunal proceedings was issued this April. Key parts of the guidance deal with (i) identifying when a participant is vulnerable, and (ii) case management: directions and orders.’

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12 King's Bench Walk, 9th June 2020

Source: www.12kbw.co.uk

Where are my black sisters? The intersection of religion, race and gender in the AAP legal community – Garden Court North Chambers

‘I am a hijabi (head-scarf wearing Muslim) Palestinian-British lawyer who has worked in the progressive Inquests/Actions Against the Police (AAP) field for the past 7 years. I started out as a paralegal, became a solicitor and am now a pupil barrister. I have met, or know of, many of the lawyers whose talent and (often unpaid) hard work props up this niche but vital corner of the legal system. Working as an AAP lawyer is beyond rewarding and the people you get to meet, clients and colleagues, are inspiring. As a hijabi AAP lawyer, this area can also be isolating and unwelcoming at times.’

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Garden Court North Chambers, 15th June 2020

Source: gcnchambers.co.uk