European Regulatory Affairs

This introduction to European regulatory procedures covers the evolution of the registration systems for product approval since January 1995 as well as major changes in new medicines legislation in the EU. It covers important changes in regulatory procedures, access to centralised and mutual recognition procedures (with practical examples of product types suitable for each procedure and the new decentralised procedure), and the reduction in regulatory data protection.

Learn about issues that impact successful regulatory strategy in Europe and how to harmonise the summary of product characteristics. Other topics covered include Article 30 and Article 31 referrals, supplementary protection certificate for patents, legal status of medicinal products, procedure for switching from prescription-only sale to over-the-counter (OTC) sales, legislation controlling medical devices, and the Clinical Trials Directive.

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