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RTF Template

Department of drug and pharmacy supervision

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_ST_01_WDA_2022_008
2. Name of Authorisation Holder	:	AMH Niemann GmbH & Co. KG
3. Address(es) of Site(s)	:	Daniel-Vorlaender-Strasse 2, Heide Sued, Halle (saale), Saxony-Anhalt, 06120, Germany

4. Legally registered address of Authorisation Holder	:	Daniel-Vorländer-Str. 2, Halle (Saale), 06120
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	:	2022-08-09
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: Amh Niemann GmbH & Co. KG

(ORG-100034722 / LOC-100055080)

, Daniel-Vorlaender-Strasse 2, Heide Sued, Halle (saale), Saxony-Anhalt, 06120, 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

Any restrictions or clarifying remarks (for all users): National legal basis of the authorisation: Section 52a (1) German Drug Law (AMG),
Supply only by drop shipment.
The authorisation based on the confirmed layout plan dated 24/11/2004.

Nationale Rechtsgrundlage der Erlaubnis: § 52a (1) Arzneimittelgesetz (AMG)
Der Handel erfolgt im Streckengeschäft.
Die Erlaubnis basiert auf den bestätigten Grundrissplan vom 24.11.2004.

Union Format for a Wholesale Distribution Authorisation	DE_ST_01_WDA_2022_008
	Page 1

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