Form

Notification for SPC manufacturing waiver

Use this form when notifying the Intellectual Property Office of your intention to use the Supplementary Protection Certificate (SPC) manufacturing waiver.

• From: Intellectual Property Office
• Published: 4 January 2021
• Last updated: 26 April 2023 — See all updates

Documents

SP5

PDF, 115 KB, 2 pages

Details

This form should be used by anyone intending to make an SPC-protected medicinal product under the “manufacturing waiver” (Article 5(2) of Regulation 469/2009). The maker must use this form to notify the Intellectual Property Office at least 3 months before any manufacturing, or any related act that would otherwise be prohibited by the SPC.

Cost

There is no fee associated with this form.

Published 4 January 2021
Last updated 26 April 2023 + show all updates

1. 26 April 2023

   A new end page has been added. This contains a checklist and sending instructions. Supporting text added to questions that required further clarification.

2. 4 January 2021

   First published.