Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 133

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 133
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 insufficiently robust.
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●   Unfettered Access (UAP) from Northern Ireland (a 70-day procedure). Applicants may seek recognition in the UK of a marketing authorization approved in Northern Ireland under certain qualifying conditions. Following implementation of the Windsor Framework, if granted, a marketing authorization (MA) made through UAP will result in a UK-wide MA and the Northern Ireland MA will be revoked.
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This route is available for marketing authorizations approved in Northern Ireland via European procedures (MR or DC procedures only).
Applications should include the dossier as approved for marketing in Northern Ireland, accompanied by all iterations of the relevant RMS assessment reports.
International routes (collaborative procedures):

●   Access consortium. The Access consortium is a medium-sized coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements for companies intending to market a medicine in the U.K., Australia, Canada, Singapore and/or Switzerland. The MHRA joined the consortium in 2020 and commenced work-sharing applications in January 2021; and
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●   Project Orbis. Project Orbis is a program coordinated by the FDA involving the regulatory authorities of Australia (TGA), Canada (Health Canada), the United Kingdom (MHRA), Singapore (HSA), Brazil (ANVISA), Israel (IMoH) and Switzerland (Swissmedic) to review and approve promising cancer treatments.
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Further information can be found in the U.K.’s website for license applications (www.gov.uk).
Canadian Regulatory Process
Authorization to Market. In 2024, Health Canada implemented several regulatory modernization initiatives to streamline product approvals and enhance responsiveness to public health needs. Notably, in November 2024, Health Canada introduced the Agile Licensing Framework, amending the Food and Drug Regulations (“FDR”) and Medical Devices Regulations (“MDR”). These amendments expand Health Canada’s authority to impose terms and conditions on market authorizations and formalize the use of rolling reviews to facilitate earlier access to promising therapies. Therapeutic products can be marketed in Canada after they have been subject to a review to assess their safety, efficacy and quality. A New Drug Submission must be submitted to Health Canada for review, and a Notice of Compliance (“NOC”), and/or a Drug Identification Number (“DIN”), must be received by the sponsor prior to marketing a product in Canada