Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

authorities definition

What does authorities mean? Authorities are the legal sources a lawyer relies on to justify a proposition of law in submissions, skeleton arguments and judgments. The term is descriptive and widely used across England & Wales, Scotland, Northern Ireland and Ireland, rather than being defined by statute. Authorities typically include: primary legislation and subordinate legislation; binding appellate case law within the relevant jurisdiction; and, as persuasive material, decisions from other UK or foreign courts, tribunal rulings, EU and ECHR jurisprudence where applicable, and reputable academic commentary. In Scotland, the writings of the institutional writers (e.g. Stair, Erskine, Bell) may carry particular weight. Textbooks and...

EU transparency and access to medicinal product information: EMA/CTIS publication regimes, EPARs, CCI/PPD protections, access and appeal procedures, and leading case law

Published by a LexisNexis Life Sciences expert

Practice notes

In recent years, interest in information on medicines has risen steadily among a wide range of stakeholders, including the general public, patient associations, physicians, the pharmaceutical industry and academia. In response, legislators and medicines regulators have embraced a more open stance, enabling access to a broader set of documents and data on the quality, safety and efficacy of medicinal products than at any time before.

Within the EU, the European Medicines Agency (EMA) is the authority charged with protecting and promoting human and animal health. Among the EMA’s core duties are the scientific assessment of applications for Marketing Authorisation (MA) via the centralised procedure, and the co-ordination of the EU Pharmacovigilance system to monitor the safety of medicinal products. Consequently, the EMA holds extensive scientific and clinical data on medicines.

There are multiple channels through which documents and information on medicinal products can be accessed...

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Prof Vincenzo Salvatore

Simmons & Simmons

I have been a qualified Italian lawyer since 1991 and hold the position of full professor of EU Law at the University of Insubria, Varese (Italy), where I also instruct on International Trade Law. Currently I am a Partner at Simmons & Simmons. Prior to this, I have served as the Head of the Healthcare and Life sciences practice at BonelliErede law firm in Milan. Before that, I spent three years with Sidley Austin LLP’s global life sciences team. My career journey includes a significant tenure at the European Medicines Agency, where I served as the Head of the Legal Service from 2004 to 2012 and as the Data Protection Officer from 2005 to 2011.I provide regular counsel to pharmaceutical companies, medical devices manufacturers, and the food and cosmetic industry on a wide range of regulatory matters related to their operations....

Web page updated on 21/05/2026

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