InFocus: Life Sciences & Healthcare e-newsletter - May 2006

In May 2006, new legislation governing the regulatory framework for medicinal products came into force in Europe. In this special edition of InFocus, we review some of the key changes introduced by the new legislation including:

• New procedure for marketing authorisations
• Data exclusivity and the introduction of market exclusivity
• New concepts: 'Global Marketing Authorisation', 'Generic Medicinal Product' and 'European Reference Product'
• Approval of biosimilar products
• New "Bolar Provision"
• SmPCs and second medical use patents
• The 'Sunset Clause'
• Patient information leaflets and labelling
• Renewals and PSURs
• Simplified registration procedure for traditional herbal medicines
• Implementation and transitional provisions 

About Taylor Wessing's Life Sciences & Healthcare Group

Taylor Wessing's market-leading Life Sciences & Healthcare Group provides a top quality, multi-disciplinary service.  The Group combines Taylor Wessing’s top-rated intellectual property and venture capital lawyers with specialists from our highly acclaimed international corporate, corporate finance, employment and real estate practices.  We advise life sciences and healthcare businesses, those who fund them and those who work for them.

For more information about Taylor Wessing's Life Sciences & Healthcare Group, please click here.

For any legal enquiries, please contact Daniel Pavin or your usual contact at Taylor Wessing.  For any marketing and business development enquiries, please contact Sharon Philbey.