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RTF Template

Generalitat De Catalunya

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	P08001413
2. Name of Authorisation Holder	:	Grifols International S.A. (ORG-100025659 / LOC-100056859)
3. Address(es) of Site(s)	:	Calle Llevant 11, Parets Del Valles, Barcelona, 08150, Spain

4. Legally registered address of Authorisation Holder	:	Passeig Fluvial N 24 Carretera N 152 Km 21, Poligono Industrial Sector Autopista, Parets Del Valles, 08150
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Real Decreto 782/2013, de 11 de octubre
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2026-03-30
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

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: Grifols International S.A.

(ORG-100025659 / LOC-100034888)

, Calle Llevant 11, Parets Del Valles, Barcelona, 08150, Spain

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	P08001413
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