{"product_id":"guide-to-eu-and-uk-sally-shorthose-9789403530253","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 volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors 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 \u003cp\u003e Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe - from its underlying rationales to the relevant committees and agencies - 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 are the following: \u003c\/p\u003e \u003cul\u003e \u003cli\u003e\n\u003cp\u003eclinical trials;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003estages and standards for creating a product dossier;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003eobtaining a marketing authorisation;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003ehow and when an abridged marketing authorisation procedure can be used;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003ecriteria for conditional marketing authorisations;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003egeneric products and 'essential similarity';\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003epaediatric use and the requisite additional trials;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003eorphan medicinal products;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003ebiologicals and 'biosimilars';\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003ehomeopathic, herbal and similar medicines;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003emedical devices;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003epandemics, epidemics and vaccines;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003epharmacovigilance;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003eparallel trade;\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003eadvertising; and\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e\n\u003cp\u003erelevant competition law, intellectual property rights and data protection regulation.\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.\u003c\/p\u003e \u003cp\u003e\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Sally Shorthose\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 9403530251\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9789403530253\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 01\/10\/2023\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 920\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 2.78lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.21h x 6.14w x 1.82d","brand":"Sally Shorthose","offers":[{"title":"Paperback","offer_id":44131032596735,"sku":"9789403530253","price":227.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_7209ac4b-b807-4145-a45a-1178e3dc84c2.jpg?v=1687472607","url":"https:\/\/www.whiterainbookhouse.com\/products\/guide-to-eu-and-uk-sally-shorthose-9789403530253","provider":"WR Book House","version":"1.0","type":"link"}