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RTF Template

Regierung Von Oberbayern

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BY_04_WDA_2024/ROB-55Ph-2678.Ph_3-84-12-4
2. Name of Authorisation Holder	:	Eurodepot GmbH (ORG-100035931 / LOC-100056881)
3. Address(es) of Site(s)	:	Semmelweisstrasse 4, Planegg, Bavaria, 82152, Germany

4. Legally registered address of Authorisation Holder	:	Semmelweisstrasse 4, Planegg, Bavaria, 82152
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-03-26
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: Eurodepot GmbH

(ORG-100035931 / LOC-100056881)

, Semmelweisstrasse 4, Planegg, Bavaria, 82152, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

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: Medicinal products requiring refrigeration

Any restrictions or clarifying remarks (for all users): 2.2: Storage by external service providers (see Annex 2)

zu 2.2: Lagerung durch externe Dienstleister (s.Anl.2)

*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	DE_BY_04_WDA_2024/ROB-55Ph-2678.Ph_3-84-12-4
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