Libby Amos' practice focuses on advising pharmaceutical and medical device clients on UK and EU regulatory matters. She assists companies on strategic issues arising during the life cycle management of pharmaceutical products and maximization of IP regulatory rights including regulatory data protection, supplementary protection certificates, paediatric rewards, and orphan market exclusivity.

In addition, Ms. Amos advises companies on the boundaries of the ABPI and EFPIA codes of practice and UK and EU legislations regarding the advertising and promotion of medicinal products and medical devices, including use of social media, packaging and labelling, presence at conferences, use of consultants, and marketing materials.

Ms. Amos also assists companies with classification of borderline products, compliance investigations, and the interface between regulatory and competition law.

Experience

  • Application for annulment of a Commission Decision as to the eligibility of an orphan medicinal product to receive a paediatric extension on the basis of a paediatric investigation plan conducted voluntarily.
  • Reference to the CJEU regarding the correct date for use in the calculation of duration of a supplementary protection certificate.
  • Action for annulment of a Commission Decision condemning a large pharmaceutical company for breach of Articles 101 and 102 TFEU.
  • Defending an action for declaratory relief that a marketing authorisation first authorised in East Germany prior to reunification constituted a valid reference medicinal product in accordance with Directive 2001/83/EC.
  • Judicial review of the grant of marketing authorisations by the MHRA of a generic product authorised under Article 10(3) of Directive 2001/83/EC by reference to data contained in the dossier of a previously authorised Article 10(3) medicinal product where the Global MA concept does not apply.

Recognition

The Dickson Poon School of Law Prize (2015)

Credentials

Education
  • Solicitor Advocate, BPP Law School, 2016
  • Post-Graduate Diploma in European Union Law, King's College London, 2015, with distinction
  • LLB, The College of Law, 2011, First Class Honours
  • BSc, Physiological Sciences, University of Bristol, 2006, First Class Honours
Admissions
  • England and Wales
  • Ireland
Overview

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