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RTF Template

Landesverwaltungsamt Sachsen-Anhalt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_ST_01_WDA_2023_007
2. Name of Authorisation Holder	:	Serumwerk Bernburg Vertriebs GmbH (ORG-100007897 / LOC-100011103)
3. Address(es) of Site(s)	:	Hallesche Landstrasse 105b, Bernburg (Saale), 06406, Germany

4. Legally registered address of Authorisation Holder	:	Hallesche Landstrasse 105b, Bernburg (Saale), 06406
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	:	2023-03-20
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: Serumwerk Bernburg Vertriebs GmbH

(ORG-100007897 / LOC-100011103)

, Hallesche Landstrasse 105b, Bernburg (Saale), 06406, 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

2.5. Other activities(s): holding as an outsourced activity in an external warehouse (see Annex 2)Lagerung in einem beauftragten Betrieb (Anlage 2)

Any restrictions or clarifying remarks (for all users): National legal basis of the authorisation: Section 52a (1) German Drug Law (AMG)
ref 1.1: Only isotonic saline solution 0.9 % for infusion.
ref 2.1 and 2.3: Supply only by drop shipment. Holding and supply as outsourced activities in an external warehouse (see Annex 2)
The authorisation based on the confirmed layout plans dated 12/02/2007.

Nationale Rechtsgrundlage für die Erlaubnis: § 52a Abs. 1 des Arzneimittelgesetzes (AMG).
zu 1.1: Handel erfolgt ausschließlich mit Isontonischer Kochsalzlösung 0,9 % zur Infusion.
zu 2.1 und 2.3: Der Handel erfolgt im Streckengeschäft. Die Warenlagerung und -lieferung erfolgt durch die in der Anlage 2 genannte Firma.
Die Erlaubnis basiert auf dem bestätigten Grundrissplan vom 12/02/2007.

Union Format for a Wholesale Distribution Authorisation	DE_ST_01_WDA_2023_007
	Page 1

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