The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Eudralex Volume 3 EMA Procedural advice for users of the centralised procedure for similar biological medicinal products applications


EMA - 7 Westferry Circus œ Canary Wharf œ London E14 4HB œ United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8668 E-mail Website

Document Type:
Question and Answers
The document includes basic questions like "What is a similar biological medicinal product?" as well as more complex questions like "If the patent situation differs in the various Member States how will this be reflected in the product information of my similar biological medicinal product?" Furthermore, the answers comprise direct links to the related regulations and guidelines.

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