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RTF Template

Xunta De Galicia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	PO-8-A
2. Name of Authorisation Holder	:	Zinereo Pharma S.L. (ORG-100034121 / LOC-100053966)
3. Address(es) of Site(s)	:	Lugar A Relva S/N, O Porrino, Pontevedra, 36410, Spain

4. Legally registered address of Authorisation Holder	:	Calle Relva S N, O Porrino, 36410
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6 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	:	2026-04-13
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: Zinereo Pharma S.L.U.

(ORG-100034121 / LOC-100053966)

, Lugar A Relva S/N, O Porrino, Pontevedra, 36410, Spain

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

2.5. Other activities(s): (please specify) Almacén por contrato / Contract warehouse

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) Temperaturas entre -15 y -30 C / Temperatures between -15 and -30 C

3.3. Other products: (please specify here or make a reference to Annex 5) Medicamentos en investigación de uso humano / Investigational medicinal products for human use

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

Union Format for a Wholesale Distribution Authorisation	PO-8-A
	Page 1

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