Specials meaning

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 | C–D | E–H | I–N | O–P. Qualified person (QP) The qualified person (QP) must confirm that every batch of medicinal products is manufactured and checked in line with UK or EU Member State law and in keeping with the marketing authorisation (MA) terms. See also: batch release marketing authorisation (MA) medicinal product Practice Note: Manufacturing of medicinal products for human use Qualified person for pharmacovigilance (QPPV) A qualified person for pharmacovigilance (QPPV) is the individual who, by law, holds personal responsibility for the safety of a human medicinal product. See also: adverse reaction marketing authorisation (MA) medicinal product Practice Note: Pharmacovigilance Rare disease See: orphan medicinal product (OMP)...

This Practice Note outlines the law on marketing authorisations (MAs) for medicinal products intended for the UK market following the close of the Brexit transition period (11 pm (GMT) on 31 December 2020, termed in UK law ‘IP completion day’). It covers: exemptions from the need to hold an MA (eg ‘specials’, investigational medicinal products (IMPs), and the Early Access to Medicines Scheme (EAMS)) the various categories of MA the licensing pathways to secure an MA in the UK, Great Britain (GB), or Northern Ireland (NI) (eg Northern Ireland Medicines and Healthcare products Regulatory Agency (MHRA) Authorised Route (NIMAR), Innovative Licensing and Access Pathway (ILAP), unfettered access, the 150‑day accelerated national procedure, rolling review, the reliance routes on EU authorisations now integrated into the International Recognition Procedure (IRP), Project Orbis and Access Consortium) information on applying the Ireland/Northern Ireland Protocol as amended under the Windsor Framework the offences and penalties arising from breaches of these provisions Governing law The...