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RTF Template

Competent Regional Authority. Dirección de Farmacia. Departamento de Salud. Gobierno del Pais Vasco

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	48802
2. Name of Authorisation Holder	:	UNIÓN DE CENTROS FARMACÉTUICOS, S.A. (UNICEFAR)
3. Address(es) of Site(s)	:	Polígono. Vega de Lapatza Aea Industrial A-1 Parcela P-3, Basauri, Vizcaya, 48970, Spain

4. Legally registered address of Authorisation Holder	:	C/SANTA ENGRACIA 31, MADRID, Madrid, 28010, Spain
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-01-29
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: UNIÓN DE CENTROS FARMACÉUTICOS, S.A. (UNICEFAR)

, Polígono. Vega de Lapatza Aea Industrial A-1 Parcela P-3, Basauri, Vizcaya, 48970, Spain

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

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)

3.4. Other products: Medicamentos veterinarios/ veterinary medicinal products

*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	48802
	Page 1

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