Libby Amos-Stone advises pharmaceutical and medical device clients on UK and EU regulatory matters and on public and administrative law litigation before the UK and EU Courts arising from the decisions of regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
Ms. Amos-Stone assists companies on strategic issues arising during the life cycle management of pharmaceutical products and maximisation of IP regulatory rights including regulatory data protection, supplementary protection certificates, paediatric rewards, and orphan market exclusivity. She also advises companies on the boundaries of the ABPI and EFPIA codes of practice and UK and EU legislation 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.
Additionally, Ms. Amos-Stone regularly advises companies on the MHRA and Home Office licensing regimes, import, manufacture, pre-clinical and clinical research, distribution and promotion of cannabis-based medicinal products.
Ms. Amos-Stone also assists companies with classification of borderline products, food, cosmetics, compliance investigations, and the interface between regulatory and competition law.
- 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.
- 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
- England and Wales