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About Generic Medicines

Overview

  • For a quick introduction to the role of generic medicines in Europe, start with our 3-minute Video Profile on this dynamic sector or visit the Basic Notions page. Check out the FAQ for remaining questions, or look up unfamiliar terms in the Glossary.

| Basic Notions | FAQ | Fact Sheets | Video | Glossary |

The Science of Generic Medicines

  • This section provides a more in-depth look at the role of science in such aspects of the generic medicines industry as: ensuring the quality, safety and efficacy of generics; the comparability of bio-similar products; the requirements of marketing authorisation; and post-approval safety monitoring...

| Guaranteed Quality | Authorisation | Pharmacovigilance |

Affordability & Sustainable Healthcare

  • The economics of healthcare provision has taken on heightened importance over the past few years with the spiralling costs of originator pharmaceuticals and the ageing of Europe's population. In addition, an ever widening gap in healthcare spending is opening up between many EU Member States ...

| Overview | Healthcare Economics | Economics of Generics |
Generics in Europe | Promoting Generics | Competition & Innovation |

Intellectual Property

  • Protecting intellectual property rights is of primary importance to encourage technological innovation. What types of IP protection are available and how are they used—or abused—by the originator pharmaceutical industry? How much protection is needed? Discover some insights in this area...

| IP Rights | Pharma Patents | Data Exclusivity | “Evergreening” |

Further Resources

  • Assembled in this area you will find a selection of interesting and accessible publications, reports, studies and internet sites that should prove useful in seeking a broader understanding of issues involving the generic pharmaceuticals industry.

| Books & Articles | Reports & Studies | Internet Resources |