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RTF Template

Landesverwaltungsamt Sachsen-Anhalt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	DE_ST_01_WDA_2023_018
2. Name of Authorisation Holder	:	Alliance Healthcare Deutschland GmbH (ORG-100015186 / LOC-100028961)
3. Address(es) of Site(s)	:	Brachwitzer Strasse 50, Sennewitz, Petersberg, Saxony-Anhalt, 06193, Germany

4. Legally registered address of Authorisation Holder	:	Solmsstrasse 73, Bockenheim, Frankfurt Am Main, 60486
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-07-24
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: Alliance Healthcare Deutschland GmbH

(ORG-100015186 / LOC-100064890)

, Brachwitzer Strasse 50, Sennewitz, Petersberg, Saxony-Anhalt, 06193, Germany

Human medicinal products

Veterinary 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

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): ref 3.1.1: subject to authorisation according to para 3 German Narcotic Drug Law
The authorisation based on the confirmed floor plan dated 15/10/2004.
furthermore marked in German wholesale trade authorisation:
"Veterinary medicinal products
point 3.1.5: narcotics or psychotropic substances (subject to authorisation according to para 3 German Narcotic Drug Law),
point 3.1.6: medicinal products for food-producing animals,
point 3.1.7: veterinary drugs subject to prescription".

zu 3.1.1: vorbehaltlich einer entsprechenden Erlaubnis nach § 3 Betäubungsmittelgesetz
Die Erlaubnis basiert auf dem bestätigten Grundrissplan vom 15.10.2004.
Weiterhin in der deutschen Erlaubnis zum Großhandel mit Arzneimitteln angekreuzt: "Tierarzneimittel
Punkt 3.1.5: Narkotika oder psychotrope Stoffe (vorbehaltlich einer Erlaubnis nach § 3 Betäubungsmittelgesetz),
Punkt 3.1.6: Arzneimittel für Lebensmitteltiere,
Punkt 3.1.7: verschreibungspflichtige Tierarzneimittel."

Union Format for a Wholesale Distribution Authorisation	DE_ST_01_WDA_2023_018
	Page 1

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