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RTF Template

Competent Regional Authority. Dirección de Regulación, Planificación y Recursos Sanitarios. Departamento de Salud. Generalitat de Catalunya

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	P08001614
2. Name of Authorisation Holder	:	Laboratorios Inibsa S.A. (ORG-100000690 / LOC-100002090)
3. Address(es) of Site(s)	:	Carretera De Sabadell A Granollers Km 14.5, Llica De Vall, 08185

4. Legally registered address of Authorisation Holder	:	Carretera De Sabadell A Granollers Km 14.5, Llica De Vall, 08185
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	:	2022-05-09
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: Laboratorios Inibsa S.A.

(ORG-100000690 / LOC-100002090)

, Carretera De Sabadell A Granollers Km 14.5, Llica De Vall, 08185

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

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

*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	P08001614
	Page 1

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