Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 131

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 131
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 European Economic Area, employ less than 250 employees and have an annual turnover of not more than €50 million or an annual balance sheet total of not more than €43 million;
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●   full reduction for pre-authorization inspections for all sponsors and 90% reduction for post-authorization inspections for small- and medium-sized enterprises;
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●   full reduction for SMEs for new applications for Community marketing authorization and 10% reduction for non-SME sponsors; and
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●   full reduction for post-authorization activities including annual fees only to small and medium sized enterprises in the first year after granting a marketing authorization.
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We have EMA Orphan Drug Designations for the following products:

●   alpha-1 proteinase inhibitor (for inhalation use) for the treatment of cystic fibrosis; and
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●   alpha-1 proteinase inhibitor (for inhalation use) for the treatment of congenital alpha-1 antitrypsin deficiency.
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Because each of these products is already authorized for a non-orphan indication in the EU, in order to obtain marketing authorization for any of the above-mentioned orphan indications, we would be required to apply for a separate marketing authorization through the Community authorization procedure for such indication, using a different proprietary name. It is not possible to extend the existing marketing authorization to cover the new orphan indication. Orphan and “non-orphan” indications cannot be covered by the same marketing authorization.

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United Kingdom Regulatory Process
The United Kingdom (“U.K.”) withdrew from the E.U. on January 31, 2020, and is no longer an E.U. Member State. A transition period, during which E.U. pharmaceutical law continued to be applicable to the U.K., ended on December 31, 2020.
As of January 1, 2021, the protocol in Ireland/Northern Ireland was applicable and had an impact on marketing authorizations for medicinal products in the U.K. with respect to Northern Ireland. However, there is a new agreement between the E.U. and the U.K. called the “Windsor Framework,” which amended the Protocol of Northern Ireland and set out the long-term arrangements for the supply of medicines into Northern Ireland. The Windsor Framework will ensure that medicines can be approved and licensed on a U.K.-wide basis by the Medicines and Healthcare products Regulatory Agency (“MHRA”) and provides for the disapplication of European