Compassionate use meaning

This Checklist flags the usual key policies that an organisation should think about putting in place, and it points to LexisNexis® Precedents you may use or tailor as appropriate. Having robust policies and procedures established will assist an organisation to control risk and also evidence compliance wherever a written policy is a regulatory necessity. Note: this Checklist is not meant to be a complete catalogue of every policy an organisation ought to hold. Extra or alternative policies might be needed from time to time to fit your organisation or to satisfy any industry or sector-specific regulatory obligations. General human resources policies Policy — Aim of this policy — LexisNexis® Precedents you could use or adapt (available subject to subscription) Adoption leave policy — To outline an organisation’s approach to adoption leave and pay. Policy—adoption leave Carer’s leave policy — To state an organisation’s policy for employees to take unpaid time away to provide or arrange care for a dependent with a long-term care...

This Practice Note examines unlicensed medicines and the routes by which they can reach patients across the EU and the UK, such as via the UK Specials regime. It then looks at deploying authorised medicines beyond the scope of their licence (commonly termed off-label use). Lastly, the Practice Note addresses liability questions linked to using medicines without a licence. The UK’s regime governing unlicensed products is largely rooted in EU legislation. Numerous EU-derived principles and obligations remain in UK domestic law, save where particular measures provide otherwise. The Note surveys both EU and UK frameworks: analysis of EU requirements should be treated as relevant to the UK system unless distinct UK rules departing from EU law are set out separately. It also summarises pertinent EU case law; for guidance on the extent to which UK courts and tribunals are bound after the Brexit implementation period, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit? The discussion covers availability routes,...

A–B | E–H | I–N | O–P | Q–V. CE marking The CE (Conformité Européene—meaning European Conformity) symbol is compulsory for certain products, including medical devices, to confirm the device meets all relevant medical device regulations before it can be lawfully marketed within the EEA. It: demonstrates the manufacturer has verified these products satisfy EU safety, health or environmental requirements signals a product’s conformity with EU legislation permits the free movement of products across the EEA In Great Britain (GB) after Brexit, the UKCA mark is the counterpart to the CE mark, available for medical devices placed on the GB market from 1 January 2021, although Northern Ireland continues to require the CE mark under EU legislation. For existing ‘legacy’ devices on the GB market, the CE mark will keep being recognised for varying periods beyond 30 June 2023 under transitional provisions, provided certain conditions are fulfilled. See related terms: conformity assessment, declaration of conformity, Notified Body and UKCA...