Medicinal Product definition

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Marketing authorisations: EU mutual recognition procedure—flowchart

Marketing authorisations: EU mutual recognition procedure—flowchart No medicinal product may be placed on the market unless it has been approved. This Flowchart outlines the procedure for obtaining an approval, known as a marketing authorisation (MA) through the mutual recognition procedure (MRP). The MRP is used to obtain marketing authorisations in one or more EU Member States where the medicinal product in question has already received an MA in another EU Member State at the time

Lifecycle of a pharmaceutical product—flowchart

Lifecycle of a pharmaceutical product—flowchart This flowchart illustrates the typical lifecycle of a medicinal product. This lifecycle can be broken down into three main stages: (1) research and development; (2) commercialisation; and the (3) post-market stage. The flowchart signposts the key regulatory stages

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Patents and SPCs—UK/EU comparison

Patents and SPCs—UK/EU comparison Background This Practice Note provides a high-level summary of key themes of comparison between the UK and EU in relation to patents and supplementary protection certificates (SPCs) that have arisen since the UK exited the EU on 31 December 2020 (IP completion day). For a comparison of other IP rights in the UK and EU, see Practice Notes: • Copyright and databases—UK/EU comparison • Trade marks—UK/EU comparison • Designs—UK/EU comparison IP law is significantly harmonised across the EU. Prior to Brexit, many aspects of UK IP law were harmonised with the EU regime, and certain unitary EU IP rights (such as EU trade marks and EU designs) were applicable and enforceable in the UK. As of 31 January 2020, the UK ceased to be an EU Member State. In accordance with the Withdrawal Agreement, the UK entered an implementation period of 11 months ending at 11 pm on IP completion day, during which it continued to be subject to EU law. Following IP completion day, the...

Patent term, renewal and restoration

Patent term, renewal and restoration This Practice Note explains how long a patent lasts, how it must be maintained by renewal in order to last that long and how to restore a patent that has lapsed or will soon lapse. Obtaining a patent in the UK There are two types of patents available in the UK: • UK national patents—these are granted by the UK Patent Office under the Patents Act 1977 (PA 1977) • UK designations of European patents (EP(UK) patents)—European patents are granted by the European Patent Office (EPO) under the European Patent Convention (EPC) but must be validated in the UK in order to have effect (be valid) there Following Brexit, the UK remains part of the European patent system and can continue to be designated in European patent applications because the EPO and the EPC (the international treaty which establishes the procedure for the granting of European patents by the EPO) are both independent of the EU. The UK has simply become another non-EU...

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Medicinal products due diligence questionnaire

Medicinal products due diligence questionnaire Introduction This medicinal products regulatory due diligence questionnaire relates to the proposed purchase by [insert buyer name] (the Buyer) of the [entire share capital of [insert name of target company] Limited incorporated in England and Wales under number [insert company number] (the Company) OR [insert description of the business to be acquired] (the Business) as a going concern, together with certain assets used in the Business] from [insert seller name] (the Seller) (the Proposed Acquisition). This questionnaire is designed to enable the Buyer, the Buyer’s solicitors and other professional advisors to obtain the legal information relating to the medicinal products UK and EU regulatory compliance of the [Company OR Business] which the Buyer requires to assist in the valuation of the [Company OR Business] and with the negotiation of the Proposed Acquisition. Please answer every question fully. Please provide your answers in italics underneath each question and provide copies of all relevant documentation, ensuring...

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What is the definition of a monograph under Regulation 251 of the Human Medicines Regulations 2012?

What is the definition of a monograph under Regulation 251 of the Human Medicines Regulations 2012? Please note that monographs also exist for herbal medicinal products (ie herbal monographs) which are not specifically referenced as considered outside the scope of this reply (and our content). Regulation 251 of the Human Medicines Regulations (HMRs 2012), SI 2012/1916 deals with medicinal product compliance with standards ‘specified in certain publications’. The regulation’s reference to monographs refers to drug ‘monographs’ (ie pharmacopoeial monographs) which, although is not defined in the statute, does refer to a term of art for medicinal products. Monographs refer to a written document that contains all of the information about a specific drug, such as its uses, doses, medicinal forms, warnings/safety issues, side-effects and other information, which the British Pharmacopoeia Commission devises and the British National Formulary (BNF) will publish (see: NICE’s BNF website for a definition and monograph listings and the British Pharmacopoeia website for ‘Contribute to monograph development and improvement’) in the UK. In the EU, the European...

Can cosmetic procedures (either surgical or non-surgical) be advertised as prizes to a prize competition?

Can cosmetic procedures (either surgical or non-surgical) be advertised as prizes to a prize competition? For information on prize promotions generally, see Practice Notes: Prize promotions and How to run a prize promotion. Prize promotions are not considered to fall within the scope of the Gambling Act 2005 (GA 2005) and, as such, GA 2005 is not considered further within this response. For the purposes of the CAP Code, the ASA defines a cosmetic intervention as: 'any intervention, procedure or treatment carried out with the primary objective of changing an aspect of a consumer’s physical appearance. This includes surgical and non-surgical interventions, both invasive and non-invasive. This does not include cosmetic products as defined in Regulation (EC) No 1223/2009.' Cosmetic interventions are regulated under Section 12 of the CAP Code. In particular, CAP Code 12.25 bans the marketing of cosmetic interventions to those under the age of 18. As such, those running a prize promotion and marketing a cosmetic procedure as a prize will need to be clear on their...

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New Clinical Trials Regulations will bring UK closer to EU regime

Life Sciences analysis: Rory Trust, director and Fraser Campbell, trainee solicitor at Burges Salmon LLP, consider the new UK Clinical Trials Regulations which are coming into force in 2026. They also make a comparison between the UK and EU clinical trial regime, among other things.

Life Sciences weekly highlights—15 May 2025

This week's edition of Life Sciences weekly highlights includes two analyses by Gill Jennings & Every LLP: one regarding the EU landscape of patent-eligible subject matter in AI healthcare and another on a judgment (Generics, Teva & Glenmark v AstraZeneca) that again demonstrates how UK patent law is diverging from the European Patent Office’s approach. Also included, are Law360 news reports on the call for the UK-US trade deal to address better pharma and IP and analysis of the Court of Appeal’s unanimous decision upholding the CMA’s initial fine against Advanz for breaking competition law through excessive pricing of liothyronine tablets to the NHS overruling the CAT’s reduction of the fines. Further stories included are news that international draft guidance establishing regulatory principles for AI’s use in pharmacovigilance was published, the ABPI warned in its response to the DHSC’s March 2025 consultation on increasing the statutory scheme payment rates for branded medicines that these rates along with VPAG payments could undermine UK pharmaceutical investment, the EMA and the HMA published...