Standard: Periods of Data and Market Exclusivity for UK Reference Medicinal Products
正文 · 中文译文
标准 英国参考药品的数据期和市场独占期 2014 – 2021年期间获批的英国参考药品及其数据保护、市场独占期届满的相关日期。 来自： 药品和保健产品监管局 发布日期： 2026年11月6日 获取有关此页面的电子邮件 文件 RMP清单附带的解释性说明 HTML 参考药品清单：数据和市场独占期届满日期 CSV，330 KB 在线查看 此文件可能不适合使用辅助技术的用户。 请求可访问格式 如果您使用辅助技术（如屏幕阅读器）并需要此文件的可访问格式版本，请发送电子邮件至 webupdates@mhra.gov.uk。请告诉我们您需要什么格式。如果您说明您使用的辅助技术，将对我们有帮助。 详细信息 在英国上市的药品受《2012年人用药品条例》（HMRs）管辖。 HMRs规定了参考药品（RMP）的概念；这是指根据条例50的规定（“初始上市许可”），依据条例49(1)(a)获得英国上市许可的药品。根据该条例获得英国上市许可的任何附加规格、药物剂型、给药途径、包装、变更和扩展，或包含在初始英国上市许可中的任何附加规格、药物剂型、给药途径、包装、变更和扩展，均属于同一“全球上市许可”（GMA）。 仿制药、生物类似药或混合型产品提交申请时可引用参照药品，但法规为这些产品规定了数据保护和上市独占期形式的知识产权保护期。初始数据保护期为参照药品（RMP）获批之日起8年，上市独占期再延长2年。 此外，孤儿药产品还有特定规则适用。 更多详情，请参阅我们关于申请类型的指南。 请参阅我们关于孤儿药产品的指南。 初始公布的名单包括在2014年1月1日至2021年12月31日期间启动全球上市许可的产品。该名单将适时扩展并定期更新以反映最新信息。 在查阅该名单之前，请阅读解释性说明。如对本页面有疑问，请发送电子邮件至 RIS.NA@MHRA.gov.uk，并在邮件主题栏中注明“Data and market protection”。 注册接收电子邮件或打印此页面 获取关于此页面的电子邮件 打印此页面 探索该主题 药品、医疗器械
正文 · 英文原文
Standard Periods of Data and Market Exclusivity for UK Reference Medicinal Products UK reference medicinal products authorised in the period 2014 – 2021 and their associated dates of expiry of data protection, marketing exclusivity. From: Medicines and Healthcare products Regulatory Agency Published: 6 November 2026 Get emails about this page Documents Explanatory notes to accompany the RMP list HTML List of reference medicinal products: data and market exclusivity expiry dates CSV, 330 KB View online This file may not be suitable for users of assistive technology. Request an accessible format If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use. Details Medicines marketed in the UK are governed by the Human Medicines Regulations 2012 (HMRs). The HMRs provide for the concept of a reference medicinal product (RMP); this is a medicinal product which has been granted a UK marketing authorisation under regulation 49(1)(a) in accordance with the provisions of regulation 50 (“the initial marketing authorisation”). Any additional strengths, pharmaceutical forms, administration routes, presentations, variations and extensions in relation to which a UK marketing authorisation is granted under that regulation or which are included in the initial UK marketing authorisation, belong to the same “global marketing authorisation” (GMA). Reference medicinal products can be referred to in applications submitted for generic, biosimilar or hybrid products, but the regulations provide for periods of intellectual property protection for these products in terms of data protection and marketing exclusivity. The initial data protection period is 8 years from authorisation of the RMP and the marketing exclusivity period is a further 2 years. In addition, there are specific rules that apply to orphan medicinal products. For more detail, refer to our guidance on types of application. See our guidance on orphan medicinal products. The initial publication includes products which started a Global Marketing Authorisation in the period from 1 January 2014 until 31 December 2021. The list will be extended in due course and periodically updated to reflect updated information. Please read the explanatory notes before referring to the list. For queries about this page please e-mail RIS.NA@MHRA.gov.uk, and include ‘Data and market protection’ in the email subject line. Sign up for emails or print this page Get emails about this page Print this page Explore the topic Medicines, medical devices
摘要 待译
UK reference medicinal products authorised in the period 2014 – 2021 and their associated dates of expiry of data protection, marketing exclusivity.