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RTF Template

Spanish Agency Of Medicines And Medical Devices

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	6562E
2. Name of Authorisation Holder	:	Laboratorios Bial S.A. (ORG-100000943 / LOC-100103475)
3. Address(es) of Site(s)	:	C/ Alcalá 265, Edificio 2, Planta2, Madrid, Madrid, 28027, Spain

4. Legally registered address of Authorisation Holder	:	Calle Del Eucalipto 33 4ª Planta, Madrid, 28016
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	WDA-D824-2010
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2026-06-29
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

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: Laboratorios BIAL, S.A.

(ORG-100000943 / LOC-100024891)

, C/ Alcalá 265, Edificio 2, Planta2, Madrid, Madrid, 28027, Spain

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.3. Supply

2.5. Other activities(s): (please specify) Laboratorio TAC de medicamentos / MAH of medicinal products with warehouse

Union Format for a Wholesale Distribution Authorisation	6562E
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