In 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 & 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.
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:
clinical trials;
stages and standards for creating a product dossier;
obtaining a marketing authorisation;
how and when an abridged marketing authorisation procedure can be used;
criteria for conditional marketing authorisations;
generic products and 'essential similarity';
paediatric use and the requisite additional trials;
orphan medicinal products;
biologicals and 'biosimilars';
homoeopathic, herbal and similar medicines;
medical devices;
pandemics, epidemics and vaccines;
pharmacovigilance;
parallel trade;
advertising; and
relevant competition law, intellectual property rights and data protection regulation.
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.
