{"product_id":"guide-to-eu-and-uk-pieter-erasmus-9789403511191","title":"Guide to EU and UK Pharmaceutical Regulatory Law","description":"\u003cp\u003eIn the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful book lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert contributors from the law firm Bird \u0026amp; Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage.\u003c\/p\u003e Following brief introductory chapters providing an overview of the regulatory framework for pharmaceuticals in Europe, a short discussion of how the overarching EU regulatory regime is poised to change in the coming years, and how the exit from the EU by the UK currently affects the regulatory regime, each of the following (twenty-one) incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective - including the all-new chapter on artificial intelligence - are the following:  \u003cul\u003e \u003cli\u003e clinical trials; \u003c\/li\u003e \u003cli\u003e stages and standards for creating a product dossier; \u003c\/li\u003e \u003cli\u003e obtaining a marketing authorisation; \u003c\/li\u003e \u003cli\u003e how and when an abridged marketing authorisation procedure can be used; \u003c\/li\u003e \u003cli\u003e criteria for conditional marketing authorisations; \u003c\/li\u003e \u003cli\u003e generic products and 'essential similarity'; \u003c\/li\u003e \u003cli\u003e paediatric use and the requisite additional trials; \u003c\/li\u003e \u003cli\u003e orphan medicinal products; \u003c\/li\u003e \u003cli\u003e biologicals and 'biosimilars'; \u003c\/li\u003e \u003cli\u003e homoeopathic, herbal and similar medicines; \u003c\/li\u003e \u003cli\u003e medical devices; \u003c\/li\u003e \u003cli\u003e pandemics, epidemics and vaccines; \u003c\/li\u003e \u003cli\u003e pharmacovigilance; \u003c\/li\u003e \u003cli\u003e parallel trade; \u003c\/li\u003e \u003cli\u003e \u0026amp;nbsp...\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Pieter Erasmus\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 9403511192\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9789403511191\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Kluwer Law International\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 10\/30\/2025\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 1096\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 3.31lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.21h x 6.14w x 2.15d\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Pieter Erasmus","offers":[{"title":"Paperback","offer_id":48460288426239,"sku":"9789403511191","price":270.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_dc7ab2db-48fa-4cd2-a352-e03676c10dff.jpg?v=1777413761","url":"https:\/\/www.whiterainbookhouse.com\/products\/guide-to-eu-and-uk-pieter-erasmus-9789403511191","provider":"WR Book House","version":"1.0","type":"link"}