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.

Updates to this page

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

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

  2. First published.

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