Guide to EU and UK Pharmaceutical Regulatory Law

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 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 & 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 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:

• 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’;

• homeopathic, 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.

 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.