Medicines Regulatory Exclusivities in the UK and Europe

Introduction

Medicines regulations are a combination of legal, administrative, and technical measures that governments implement to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information. The system applies over the course of a product’s life cycle starting at premarket screening and evaluation of new products to provide authorisations to sell, inspection of manufacturing facilities, regulation of drug labelling and promotional activities, through to the post marketing surveillance of drugs following approval.

The regulation of medicines in the UK and Europe is a dynamic and changing area and is business critical for medicines, pharmaceutical and biotech companies. Brexit has also had a significant impact on the regulatory landscape in the UK and across Europe and the position is still uncertain.

This session will provide an overview of exclusivity rights covering medicines and medicinal products, including Intellectual Property and regulatory exclusivity, in the UK and Europe, the criteria for obtaining market and regulatory data exclusivity for a product and the impact of Brexit on these regimes. It will touch on political developments including the Northern Ireland Protocol and consider further additional rights available in the form of orphan designations and paediatric exclusivity.

What You Will Learn

This webinar will cover the following:

• An overview of exclusivity rights available for medicines and medicinal products, including IP and regulatory exclusivity, in the UK and Europe
• Patents and Supplementary Protection Certificates
• The route to obtain a marketing authorisation in the UK and EU
• Regulatory market and data exclusivity - criteria and timeframe
• The impact of Brexit on the regulatory landscape, including the Northern Ireland Protocol
• Further exclusivity rights:
• Orphan market exclusivity
• Paediatric exclusivity (including the GB position)

This webinar was recorded on 28th November 2022