Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


Deal On European SPC Manufacturing Waiver Is An Acceptable Compromise

Executive Summary

A deal on the European supplementary protection certificate manufacturing waiver has been agreed by the European Council, Parliament and the European Commission, providing a concrete path for a regulation to move forward, albeit with compromises on several key provisions. Meanwhile, the European off-patent and brand industries remain at odds over the benefits of the waiver.

You may also be interested in...

Monitoring To Start As EU SPC Waiver Nears Finishing Line

A manufacturing waiver to allow EU-based companies to produce generics and biosimilars during the SPC term is expected to gain final approval shortly. However, the European Commission will be watching closely to see whether the provision is actually used by industry.

Foreign Vested Interest Must Not Sway Away From SPC Waiver

Attempts by the US administration to derail a proposed SPC manufacturing waiver must not be allowed to succeed, Medicines for Europe is warning.

Two-Year Stockpiling Provision ‘Vastly Improves’ European SPC Waiver

The latest vote from the European Parliament’s legal committee has been praised by industry for allowing firms to stockpile for two years ahead of SPC expiry to prepare for a ‘day one’ launch.


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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