Elisabethann Wright , BL
Elisabethann Wright specializes in EU law and regulation of pharmaceuticals and medical devices and is regularly sought-after and praised for her knowledge of the legislation, technical competence and commercial acumen. She has been practicing in the life sciences sector for over 35 years in private practice and international institutions. Elisabethann helps clients navigate the process and regulations to place and keep their products on the European Union market through strategic advice, advocacy before institutions and agencies and litigation before EU courts.
Practice Area
Panel
- Contributing Author
Qualified Year
- 1989
Membership
- Women's Law Network
Education
- B.L., The Institute of Professional Legal Studies, Belfast, 1985
- Postgraduate Diploma in EC Competition Law, King's College London, 2004
- LL.B., The Queen's University of Belfast, 1984
1 Contributions by Elisabethann Wright
PRACTICE NOTES
EU and UK regulatory data protection for medicinal products: 8+2+1 rule, global marketing authorisation, orphan exclusivity, OTC/indication extensions, and post‑Brexit (GB/NI) regime and reforms
Directive 2001/83/EC (the Pharmaceutical Code) introduces a period of data exclusivity starting from the first authorisation of innovative medicinal products, during which the pre-clinical and clinical trial evidence produced to support that approval cannot be relied upon by any applicant seeking a marketing authorisation (MA) for a generic medicine. During this time, such data may not be cited or cross‑referred to by others at all.
Accordingly, data exclusivity provides innovative companies with assurance that the scientific material prepared for the MA of the innovative product is safeguarded and will not be used to evaluate dossiers submitted by makers of generic or biosimilar medicines until the exclusivity enjoyed by the innovative product has expired. This protection is also termed regulatory data protection (RDP).
This Practice Note sets out an overview of the relevant EU rules that govern RDP for MAs covering innovative medicinal products and considers how those rules affect the timing of market entry for generic and biosimilar medicines. It further outlines how RDP is addressed in the UK.
Introduction to the concept of regulatory data protection
An ‘innovative medicinal product’, also known as a ‘reference medicinal product’ owing to its role in the authorisation of later generic or biosimilar...
Life Sciences
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