Generics Bulletin is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


European SPC Waiver Becomes A Reality With Council Adoption

Executive Summary

Less than a month after it was passed by the European Parliament, a waiver to allow manufacturing of generics and biosimilars during the SPC period, as well as stockpiling for a European ‘day one’ launch upon SPC expiry, has been formally adopted by the European Council.


Related Content

Formycon Plans Ranibizumab Filings With Ustekinumab And Aflibercept In The Wings
Gemme Hits Back At French ‘Denigration’
European Parliament Passes SPC Manufacturing Waiver
Monitoring To Start As SPC Waiver Nears Finishing Line
Deal On European SPC Manufacturing Waiver Is An Acceptable Compromise
Two-Year Stockpiling Provision ‘Vastly Improves’ European SPC Waiver


What to read next




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts