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RTF Template

Gobierno Del Pais Vasco

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	48-809
2. Name of Authorisation Holder	:	Lavigor 7000 S.L. (ORG-100005909 / LOC-100009356)
3. Address(es) of Site(s)	:	Ugaldeguren Kalea 1, Poligono Industrial Ugaldegur, Derio, 48160, Spain

4. Legally registered address of Authorisation Holder	:	Ugaldeguren Kalea 1, Poligono Industrial Ugaldegur, Derio, 48160
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	:	2025-12-16
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: Lavigor 7000 S.L.

(ORG-100005909 / LOC-100009356)

, Ugaldeguren Kalea 1, Poligono Industrial Ugaldegur, Derio, 48160, Spain

Human medicinal products

1. MEDICINAL PRODUCTS

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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Almacén monográfico de productos homeopáticos

Any restrictions or clarifying remarks (for all users): COMO REPRESENTANTE LOCAL DEL LABORATORIO ALEMÁN PHARMAZEUTISCHE FABRIK DR. RECKEWEG CO GMBH, SÓLO DISTIBUIRÁ MEDICAMENTOS AUTORIZADOS DEL MISMO.

COMO REPRESENTANTE LOCAL DEL LABORATORIO ALEMÁN PHARMAZEUTISCHE FABRIK DR. RECKEWEG CO GMBH, SÓLO DISTIBUIRÁ MEDICAMENTOS AUTORIZADOS DEL MISMO.

*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	48-809
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