Legal Guidance and Research / Experts / Richard Welfare

Richard Welfare

Richard Welfare focuses on regulatory compliance work within the Commercial Law practice area.

Richard works with manufacturing companies to ensure that they comply with legislation and regulatory frameworks, including requirements governing product composition, labeling, packaging and claims, rules relating to advertising and marketing campaigns and other key considerations when launching a product in the EU/UK. Richard has helped clients resolve issues with UK enforcement authorities, including Trading Standards, the ASA (Advertising), MHRA (Medical Devices) and the FSA (Food).

Richard has worked with in-house counsel and corporate affairs teams to design and implement public affairs programs and targeted communication strategies, and has worked with companies to design safety programs, following safety or product quality crises.

Richard advises clients on the contracting arrangements, providing commercial support to in-house teams. He works on a variety of contracts including those for supply, co-manufacturing, distribution, logistics, warehousing, agency and general trading terms. Richard also represents companies in the appointment of celebrities for advertising or endorsement campaigns and major sponsorship opportunities.

Practice Area

Panel

  • Contributing Author

Qualified Year

  • 1996

Membership

  • SRA

Education

  • Modern History, King's College London 1991
  • Common Professional Examination, London 1993
  • Legal Professional Course, London 1994

1 Contributions by Richard Welfare

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
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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