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.
https://www.gov.uk/government/publications/notification-for-spc-manufacturing-waiver
Content Reproduced verbatim from the Website of the United Kingdom Intellectual Property Office (UKIPO) as permitted under their Terms of Use.