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934121

registered interest
date	03/07/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Drugs: Licensing
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, if he will close the legal loopholes to make the market for unlicensed medicinal products less restricted.
tabling member constituency	Bath
tabling member printed	Wera Hobhouse
uin	160334
answer	answer is ministerial correction date of answer 06/07/2018 answer text <p>The Medicines and Health products Regulatory Agency (MHRA), the Government body responsible for the safety and licensing of medicines in the United Kingdom, is not aware of any legal loopholes for the supply of human unlicensed medicinal products.</p><p> </p><p>Before a human medicine can be marketed or sold in the UK, a number of licences are required. The product itself must have a licence called a ‘marketing authorisation’ unless an exemption applies.</p><p> </p><p>UK medicines legislation contains a provision for the supply of an unlicensed medicine (commonly known as ‘specials’) which is provided for by way of an exemption from the requirement for a marketing authorisation. In the interests of public health this exemption is narrowly drawn because these products, unlike products holding a marketing authorisation, will not have been assessed and approved against the criteria of safety, quality and efficacy in the UK.</p><p> </p><p>Unlicensed medicines can be manufactured in the UK under European Union good manufacturing practice or imported into the UK by the holder of an appropriate licence issued by the MHRA.</p><p> </p><p>Notifications prior to importation of unlicensed medicines are required and are assessed by the MHRA and objections may be raised where there are prohibitive safety or quality concerns. Any person that sells or supplies an unlicensed medicine is required to keep records and report suspected adverse drug reactions.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 06/07/2018 12:28:35 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	4602 label Biography information for Wera Hobhouse

934270

registered interest
date	03/07/2018
answering body	Ministry of Justice
answering dept id	54
answering dept short name	Justice
answering dept sort name	Justice
hansard heading	Legal Representation: Low Incomes
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Justice, what steps his Department is taking to ensure access to legal representation for people with low incomes.
tabling member constituency	Bath
tabling member printed	Wera Hobhouse
uin	160335
answer	answer is ministerial correction date of answer 06/07/2018 answer text <p>The ability of individuals to resolve their legal problems is vital to a just society. Legal aid continues to be available in the highest priority cases – for example, when an individual’s life or liberty is at stake, when someone faces the loss of their home, in domestic violence cases, or when children may be taken into care – subject to an applicant passing the test of means and merits. In the Crown Court, over 99% of applications for legally-aided representation are granted.</p><p> </p><p>As part of the evidence gathering phase of the Post-Implementation Review of the Legal Aid, Sentencing and Punishment of Offenders Act 2012, we are gathering evidence on people’s ability to access legal support to resolve their legal issues. The evidence gathered will be used to inform our wider considerations for the future of legal support in the justice system.</p> answering member constituency Penrith and The Border answering member printed Rory Stewart question first answered 06/07/2018 13:59:18 answering member 4137 label Biography information for Rory Stewart
tabling member	4602 label Biography information for Wera Hobhouse