Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 129

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 129
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, neurodegenerative disorders, diabetes, autoimmune diseases and other immune dysfunctions or viral diseases; and
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●   officially designated orphan medicines (medicines for rare diseases).
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The Community authorization procedure is optional for products:

●   containing new active substances for indications other than those stated above;
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●   representing significant therapeutic, scientific or technical innovations; or
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●   for which the granting of a Community marketing authorization would be in the interests of European Union public health.
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Our blood derivative products are not subject to compulsory Community authorization, but it is an option for our new products. Flebogamma® DIF 50 mg/ml and 100 mg/ml, VeraSeal solutions for sealant and Tavlesse (fostamatinib) were approved through the Community authorization procedure.
Applications through the Community authorization procedure are submitted directly to the EMA. Evaluation by the EMA’s relevant scientific committee takes up to 210 days, at the end of which the committee adopts an opinion on whether the medicine should be marketed. This opinion is then transmitted to the European Commission, which has the ultimate authority for granting marketing authorizations in the European Union.
Once a Community marketing authorization has been granted, the holder of that authorization can begin to make the medicine available to patients and healthcare professionals in all European Union countries.

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National Authorization Procedures
Each European Union member state has its own procedures for the authorization, within its own territory, of medicines that fall outside the scope of the Community authorization procedure. There are two possible routes available to companies for the authorization of such medicines in several countries simultaneously.

●   Decentralized procedure. Using the decentralized procedure, companies may apply for simultaneous authorization in more than one European Union country of medicines that have not yet been authorized in any European Union country and that do not fall within the mandatory scope of the centralized procedure.
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●   Mutual-recognition procedure. In the mutual-recognition procedure, a medicine is first authorized in one European Union member state, in accordance with the national procedures of that country. Following such authorization, further marketing authorizations can be sought from other European Union member states in a procedure whereby the countries concerned agree to recognize the validity of the original, national marketing authorization.
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Our products Niuliva 250 I.U./ml and Xembify 200 mg/ml were approved through the decentralized procedure. Our products Prolastina® 100