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RTF Template

Gobierno De La Comunidad De Madrid

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	0022-MAD
2. Name of Authorisation Holder	:	Curium Pharma Spain S.A. (ORG-100002857 / LOC-100001243)
3. Address(es) of Site(s)	:	Calle De Manuel Bartolome Cossio 10, Madrid, 28040, Spain

4. Legally registered address of Authorisation Holder	:	Avenida Del Doctor Severo Ochoa 29, Parque Empresarial Casablanca, Alcobendas, 28100
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	:	2025-05-19
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: Curium Pharma Spain S.A.

(ORG-100002857 / LOC-100050703)

, Calle De Manuel Bartolome Cossio 10, Madrid, 28040, 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*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

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	0022-MAD
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