[6-K] Grifols SA Current Report (Foreign Issuer)
Rhea-AI Filing Summary
Grifols, S.A. reports that the European Medicines Agency (EMA) has issued a Certificate of Compliance with Community legislation for plasma supplied by Grifols Egypt for Plasma Derivatives (GEPD), the joint venture created in 2020 with Egypt’s National Service Projects Organization. This certification follows EMA inspection of GEPD’s plasma centers and verification that donor selection, plasma collection, quality controls, and storage meet European quality and safety standards.
The EMA certification allows GEPD not only to manufacture plasma-derived products but also to commercialize them throughout Europe and in countries that follow EMA legislation. Grifols describes this as a huge milestone, noting it is the first plasma company to achieve this step for Egyptian plasma, and that it positions Egypt as the first country in Africa and the Middle East with a fully integrated plasma collection and processing system meeting these strict international standards.
Positive
- None.
Negative
- None.
Insights
EMA certification validates GEPD’s plasma for EU markets, opening a new regulated commercialization pathway.
Grifols discloses that GEPD, its 2020 joint venture with Egypt’s National Service Projects Organization, has received an EMA Certificate of Compliance with Community legislation for plasma supplied from Egypt. This follows detailed inspections of plasma centers and confirmation that donor screening, collection methods, quality controls, and storage align with European standards.
The certification permits GEPD to manufacture plasma-derived products and commercialize them across Europe and in countries that follow EMA rules. That removes a key regulatory barrier and could enable the joint venture to access higher-value markets, though no volumes or financial figures are provided in the disclosure.
Management characterizes the milestone as significant, emphasizing that Grifols is the first plasma company to achieve this for Egyptian plasma and that Egypt becomes the first country in Africa and the Middle East with a fully integrated system meeting strict international standards. Future company reports may clarify production ramp-up and commercial traction stemming from this certification.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO
RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of December 2025
Commission File No. 001-35193
Grifols, S.A.
(Translation of registrant’s name into English)
Avinguda de la Generalitat, 152-158
Parc de Negocis Can Sant Joan
Sant Cugat del Valles 08174
Barcelona, Spain
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Grifols, S.A.
TABLE OF CONTENTS
| Item | Sequential Page Number | ||
| 1. | Other Relevant Information, dated December 16, 2025 | 3 | |
| 2 |
 |
Grifols, S.A. Avinguda de la Generalitat 152-158 08174 Sant Cugat del Vallès Barcelona - SPAIN Tel. [34] 935 710 500 Fax [34] 935 710 267 www.grifols.com |
Pursuant to the provisions of Article 227 of Law 6/2023 of March 17, on Securities Markets and Investment Services, Grifols, S.A. (“Grifols” or the “Company”) hereby informs about the following
OTHER RELEVANT INFORMATION
Grifols informs that on December 11, 2025, the European Medicines Agency (EMA) has issued the Certificate of Compliance with Community legislation for the plasma supplied by Grifols Egypt for Plasma Derivatives (GEPD), the joint venture established in 2020 jointly between Grifols and Egypt’s National Service Projects Organization.
This certification has been granted after the quality inspection to the plasma centers owned by GEPD and after the review by the EMA that all procedures, selection of donors, plasma obtention methods, quality controls, and storage (among others) comply with the quality and security standards required by European legislation.
This certification will allow not only to manufacture plasma products by GEPD but also to commercialize them throughout Europe and in all countries that follow EMA legislation.
The achievement of this certification from the EMA for the Egyptian plasma is a huge milestone for the Company and Grifols has been the first plasma company in accomplishing this significant step.
This recognition positions Egypt as the first country in Africa and the Middle East to operate a fully integrated plasma collection and processing system that meets the strictest international standards.
| In Barcelona, on 16 December 2025 | |
| Núria Martín Barnés | |
| Secretary to the Board of Directors |
| 3 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereto duly authorized.
| Grifols, S.A. | |||
| By: | /s/ David I. Bell | ||
| Name: | David I. Bell | ||
| Title: | Authorized Signatory | ||
Date: December 16, 2025
