A–B | C–D | E–H | O–P | Q–V. Immunological medicinal product Article 1(4) of Directive 2001/83/EC (the Pharmaceutical Code) defines immunological medicinal product as any medicinal product consisting of vaccines, toxins, serums or allergen products: • vaccines, toxins and serums cover in particular: ◦ agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine ◦ agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin ◦ agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin • ‘allergen product’ means any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergising agent In vitro diagnostic medical device (IVD) In vitro diagnostic medical devices (IVDs) are tests done on samples such as human blood or tissue to detect diseases or conditions and can be used to monitor a person’s health or for precision medicine purposes. Examples include, genetic, genomic and coronavirus

A–B | C–D | E–H | I–N | Q–V. Officinal formula There are exceptions to the requirement that medicinal products must have obtained a marketing authorisation (MA) before being placed on the market. It is not necessary to obtain an MA in respect of medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to patients served by the pharmacy in question. This is known as the officinal formula. See also: magistral formula and Practice Note: Unlicensed medicinal products and off-label use of medicinal products—Exemptions under Article 3 of the Pharmaceutical Code and equivalent provisions of the Medicines Act 1968 and Human Medicines Regulations 2012. Off-label The intentional use of an authorised medicinal product outside the terms of its MA (eg for a different indication, use of a different dose or in a different patient population). In respect of medical devices, it is considered off-label use if you use a medical device differently from how the manufacturer has instructed. See also: medical device, medicinal

A–B | C–D | E–H | I–N | O–P. Qualified person (QP) The qualified person (QP) is responsible for ensuring that each batch of medicinal products has been manufactured and controlled in compliance with the UK or EU Member State’s law and in accordance with the marketing authorisation (MA) requirements. See also: batch release, marketing authorisation (MA), medicinal product and Practice Note: Manufacturing of medicinal products for human use. Qualified person for pharmacovigilance (QPPV) A qualified person responsible for pharmacovigilance (QPPV) is an individual who is personally responsible by law for the safety of a human medicinal product. See also: adverse reaction, marketing authorisation (MA), medicinal product and Practice Note: Pharmacovigilance. Rare disease See: orphan medicinal product (OMP). Reference medicinal product A reference medicinal product is one which has been granted an MA on the basis of a complete dossier, ie with the submission of quality, pre-clinical and clinical data (in accordance with Article 8(3), 10a, 10b or 10c of Directive 2001/83/EC, or the Human Medicines Regulations 2012 (HMR 2012), SI 2012/1916, regs

The UK Government has published its Modern Industrial Strategy 2025, outlining a 10-year plan to boost investment and productivity across eight key sectors, including life sciences. The strategy confirms that each sector will have a dedicated Sector Plan to provide specific detail, with the life sciences plan expected to align closely with the forthcoming NHS 10-year plan.

ARCHIVED: This Practice Note has been archived and it is not maintained. It contains closed legislative proposals, published judgments and closed consultations that are no longer featured in the current Life sciences tracker—UK and Life sciences tracker—EU because they are not from the current year. To track the progress of current legislative proposals, relevant cases and consultations related to life sciences, see Practice Notes: Life sciences tracker—UK and Life sciences tracker—EU. Jump to: • Legislation • Judgments—Patents • Judgments—Supplementary protection certificates • Judgments—Medical devices and medicinal products • Judgments—Access to documents • Judgments—Trade marks • Consultations For current items on life sciences, see Practice Notes: Life sciences tracker—UK and Life sciences tracker—EU. For key developments and guidance related to Brexit in the life sciences sector, including the timeline of the relocation of the European Medicines Agency (EMA), see Practice Note: Life sciences—Brexit tracker. Legislation For current legislation, see Practice Notes: Life sciences tracker—UK—Legislation and Life sciences tracker—EU—Legislation. What's happening? When? Find out more Regulation amending Regulation (EC) 469/2009 concerning the supplementary protection certificates (SPCs) for medicinal

This Practice Note is intended to be used to track the progress of EU legislative proposals and current consultations relevant to the life sciences sector. However, for developments specific to the medical devices regulatory framework and its related guidance and ongoing reform, see Practice Notes: The EU MDR and IVDR implementing acts and guidance tracker and Medical devices—UK and EU regimes comparison. To track and horizon scan for developments that relate to the pricing and reimbursement of medicines and innovative technologies in the EU through the implementation of the Health Technology Assessment (HTA) Regulation (EU) 2021/2282 (the HTAR), which began application from 12 January 2025 on a rolling basis, and to track the progress of its ongoing extensive implementation through secondary legislation, guidance and industry feedback, see Practice Note: Health Technology Assessment in the EU, and, in particular, its sections: Horizon scanning—2026 and beyond, Tracker—log of HTA reform developments and important dates by reverse chronology and Rolling implementation overview. Other related specific and topical trackers in the life sciences not covered in this tracker include:

ARCHIVED: This Practice Note has been archived and is no longer maintained. It tracked the progress of EU legislative proposals and consultations relevant to the life sciences sector between 2019–2022 which were independent of events specifically related to the coronavirus (COVID-19) pandemic and Brexit during that period which have their own dedicated, archived trackers. This tracker is divided into the below sections: • Legislation • Consultations To track the progress of current EU legislative proposals, consultations and developments, as well as significant cases, which are relevant to the life sciences sector, see Practice Notes: Life sciences tracker—EU, Life sciences cases tracker—EU and Patents tracker—EU. To track the progress of current UK legislative proposals, consultations and developments, as well as significant cases, which are relevant to the life sciences sector, see Practice Notes: Life sciences tracker—UK and Life sciences cases tracker—UK. For a summary listing all life sciences trackers, see: Trackers (Life Sciences)—overview. For older archived items about developments in the life sciences or those related to the coronavirus (COVID-19) pandemic or Brexit,

This Practice Note is intended to be used to track the progress of UK legislative proposals, consultations and other key regulatory and governance developments relevant to the life sciences sector generally. However, separate topical dedicated trackers exist to track the progress of developments related to medical devices; pricing and reimbursement and commercialisation; UK block exemptions; and AI and digital health in the UK. For any developments in these areas, see below related trackers: • UK medical devices regulatory horizon scanner and tracker • AI in life sciences and digital health tracker—UK • UK pricing and reimbursement—horizon scanner and tracker • UK block exemptions revision—tracker For a round-up of key Life Sciences developments in the UK in 2025 and a look ahead to what’s coming in 2026, see News Analysis: Life Sciences UK—key developments in 2025 and horizon scanning for 2026. For an overview of all trackers available in the life sciences, see: Trackers (Life Sciences)—overview. Jump to: • Legislation • Government initiatives and proposed reforms (ie strategies, delivery plans, road maps, reports and pilot schemes) • Consultations To

ARCHIVED: This Practice Note has been archived and is no longer maintained. It tracked the progress of UK legislative proposals and consultations relevant to the life sciences sector between 2019–2022 which were independent of events specifically related to the coronavirus (COVID-19) pandemic and Brexit during that period which have their own dedicated, archived trackers. To track the progress of current UK legislative proposals, consultations and developments, as well as significant cases, which are relevant to the life sciences sector, see Practice Notes: Life sciences tracker—UK and Life sciences cases tracker—UK. To track the progress of current EU legislative proposals, consultations and developments, as well as significant cases, which are relevant to the life sciences sector, see Practice Notes: Life sciences tracker—EU and Life sciences cases tracker—EU. For older archived items about developments in the life sciences or those related to the coronavirus (COVID-19) pandemic or Brexit, see Practice Notes: • Coronavirus (COVID-19)—UK life sciences tracker [Archived] • Coronavirus (COVID-19)—EU life sciences tracker [Archived] • Life sciences—Brexit tracker 2020–2022 [Archived] • Life sciences—Brexit tracker 2017–2020 [Archived] • Patents

ARCHIVED: This Practice Note has been archived and it is not maintained. It contains previous key developments and guidance related to Brexit in the life sciences sector, including withdrawn and no-deal guidance, past government policy papers, industry reports and information on the relocation of the European Medicines Agency. To track the progress of recent key developments and guidance related to Brexit in the life sciences sector, see Practice Note: Life sciences—Brexit tracker 2020–2022 [Archived]. Jump to: • Negotiations on the future EU-UK relationship • Regulatory guidance • UK government policy papers, documents and consultations • UK Parliament inquiries, briefing papers and updates • Industry and independent reports • Relocation of the EMA Negotiations on the future EU-UK relationship The Political Declaration The Political Declaration, which set out the framework for the future EU-UK relationship, was agreed by the UK and the EU in October 2019. The Political Declaration, which is a non-binding agreement, includes the following key objectives of interest to the life sciences sector: • exploring options for UK participation in EU programmes in

ARCHIVED: This Practice Note has been archived and is not maintained. This Practice Note is intended to be used to track key developments and guidance related to Brexit in the life sciences sector. Jump to: • Implementation of the Ireland/Northern Ireland Protocol—EU-UK Trade and Cooperation Agreement • UK legislation • Regulatory guidance • UK government policy papers, documents and consultations • UK Parliament inquiries, briefing papers and updates For an overview and more detailed discussion of the regulation of medicinal products, clinical trials and medical devices after the end of the transition period, see Practice Notes: • Post-Brexit transition period—the regulation of medicinal products • Clinical trials in the UK • The regulation of medical devices in the UK For previous key developments, including withdrawn and no-deal guidance, past government policy papers, industry reports and information on the relocation of the European Medicines Agency (EMA), see Practice Note: Life sciences—Brexit tracker 2017–2020 [Archived]. Implementation of the Ireland/Northern Ireland Protocol—EU-UK Trade and Cooperation Agreement For information on the key steps of the negotiations

This new starter guide provides an introduction to the Life Sciences practice area, the legislative and regulatory framework which governs the life sciences sector and the types of work that life sciences lawyers do. It is aimed at trainee solicitors and those who are new to life sciences as a sector. It covers: • An introduction to the life sciences sector • Life sciences glossary • What do life sciences lawyers do? • Key topics in life sciences • Q&As • Further reading materials • Key external links for life sciences lawyers This guide is intended to help you make the most of the Lexis®+ UK life sciences materials by explaining how to find them, sign up for daily and weekly news alerts, access Q&As and submit a query to the LexisAsk team. Where something is not covered by this basic guide, you can use the Topics tab or Topics dropdown menu to browse further practice area content. Those who are new to life sciences are also likely to find the Overviews