1. Authorisation Number

:

1808 H

2. Name of Authorisation Holder

:

KRKA Belgium

(ORG-100019342 / LOC-100037988)

2.a. Alternative name of authorisation holder (optional)

:

KRKA Belgium N.V.

3. Address(es) of Site(s)

:

Industriepark-West 75, Sint-Niklaas, 9100, Belgium 

4. Legally registered address of Authorisation Holder

:

Louizalaan 221, Brussels, 1050

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 77(1) of Directive 2001/83/EC

7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:

9. Date

:

2025-10-30

10. Annexes attached

:

Annex 1 Scope of wholesale distribution authorisation

Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number

Annex 3 (Optional) Name(s) of responsible person(s)

Annex 4 (Optional) Date of Inspection on which authorisation was granted

Annex 5 (Optional) Additional provisions based on national requirements

Name and address of the site: KRKA Belgium

(ORG-100019342 / LOC-100037991)

, Industriepark-West 75, Sint-Niklaas, 9100, Belgium   

Human medicinal products

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation

1808 H

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