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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	:	0016-MAD
2. Name of Authorisation Holder	:	Ups Scs Spain S.L. (ORG-100019953 / LOC-100038347)
3. Address(es) of Site(s)	:	Calle De Francisco Rabal 7, Poligono Industrial Cointra, Alcala De Henares, 28806, Spain

4. Legally registered address of Authorisation Holder	:	Avenida Del Sistema Solar 17, Industrial San Fernando Sur, San Fernando De Henares, 28830
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2019-09-03
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: Ups Scs Spain S.L.

(ORG-100019953 / LOC-100038348)

, Calle De Francisco Rabal 7, Poligono Industrial Cointra, Alcala De Henares, 28806, Spain

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

2.5. Other activities(s): Almacén por contrato/ contract warehouse

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

Union Format for a Wholesale Distribution Authorisation	0016-MAD
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