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RTF Template

Regierungsprasidium Tubingen - Referat 26: Ubrige Pharmazeutische Bereiche

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BW_05_WDA_2023_0002
2. Name of Authorisation Holder	:	Scandium Pharma GmbH (ORG-100046432 / LOC-100076608)
3. Address(es) of Site(s)	:	Friedrich-Ebert-Strasse 20/1, Wangen Im Allgaeu, Baden-Wuerttemberg, 88239, Germany

4. Legally registered address of Authorisation Holder	:	Friedrich-Ebert-Strasse 20/1, Wangen Im Allgaeu, Baden-Wuerttemberg, 88239
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-01-23
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: Scandium Pharma GmbH

(ORG-100046432 / LOC-100076608)

, Friedrich-Ebert-Strasse 20/1, Wangen Im Allgaeu, Baden-Wuerttemberg, 88239, 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

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Ref 2.1 and 2.3: partially supply only by drop shipment

This wholesale distribution authorisation is based on floor plans sent with letter of 12th December 2022 and comprises the rooms "Nr. 1" till "Nr. 8" in the groundfloor (version: 12/12/2022).

Zu 2.1 und 2.3: Handel erfolgt (teilweise) im Streckengeschäft (Handel ohne Lagerung).
Diese Erlaubnis basiert auf den mit Schreiben vom 12.12.2022 übersandten Grundrissplan und umfasst im Erdgeschoss die Räume „Nr. 1" bis „Nr. 8" (Stand: 12.12.2022).

Union Format for a Wholesale Distribution Authorisation	DE_BW_05_WDA_2023_0002
	Page 1

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