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.
Documents
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 2021Last updated 26 April 2023 + show all updates
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A new end page has been added. This contains a checklist and sending instructions. Supporting text added to questions that required further clarification.
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First published.