Off label definition

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What is considered advertising of medicinal products?

What is considered advertising of medicinal products? This Practice Note examines the meaning of advertising within the regulatory framework on the advertising and promotion of medicinal products. It considers what activities may constitute advertising and therefore fall within the scope of the strict rules on advertising and promotion of medicinal products. Note that this Practice Note contains references to case law of the Court of Justice of the European Union. For guidance on whether judgments of the Court of Justice are binding on UK courts, see Practice Note: Assimilated law—Assimilated case law . Advertising within the regulatory framework in the UK and EU Not all information referring to a particular medicinal product is considered promotional or constitutes advertising, but it is a fine line that can be difficult to discern with potentially serious repercussions for pharmaceutical companies and other parties involved with the communication of information about medicines. For more information about the potential sanctions and enforcement procedure in the UK, see Practice Note: Enforcement of the rules...

Life sciences glossary E–H

Life sciences glossary E–H A–B | C–D | I–N | O–P | Q–V. Early access to medicines scheme Under the early access to medicines scheme (EAMS), the Medicines and Healthcare products Regulatory Agency (MHRA) grants patients with life-threatening or seriously debilitating conditions access to medicines which do not yet have marketing authorisation (MA) (or are not licensed to treat that indication yet) but where there is a clear unmet medical need. For more information, see Practice Notes: UK marketing authorisations for medicinal products—Early access to medicines scheme (EAMS)—exemption and Unlicensed medicinal products and off-label use of medicinal products—Early access to medicines scheme (EAMS)—UK regime and MHRA guidance: Apply for the early access to medicines scheme (EAMS). EFPIA Code The EFPIA Code is a collection of industry, self-governance ethical rules of conduct that govern the promotion of prescription-only medicines (POMs) by all European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies when interacting with healthcare professionals (HCPs) healthcare organisations (HCOs), patients’ organisations (POs) and the general public. This includes pharmaceutical...

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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...