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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-01-31

RTF Template

Landesdirektion Sachsen LDS

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	DE_SN_01_WDA_2023_0010
2. Name of Authorisation Holder	:	Alliance Healthcare Deutschland GmbH (ORG-100015186 / LOC-100028961)
3. Address(es) of Site(s)	:	Grenzstrasse 18, Klotzsche, Dresden, Saxony, 01109, 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	:	2023-07-03
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-100041894)

, Grenzstrasse 18, Klotzsche, Dresden, Saxony, 01109, 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

2.4. Export

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): 3.1.1: subject to a corresponding authorisation according to § 3 BtMG;

furthermore marked in German wholesale trade authorisation:
"Veterinary medicinal products: point 3.1.5 narcotics or psychotropic substances; point 3.1.6 medicinal products for food-producing animals".
3.1.5: subject to a corresponding authorisation according to § 3 BtMG.

zu 3.1.1: vorbehaltlich einer entsprechenden Erlaubnis nach § 3 BtMG;

des Weiteren in deutscher Erlaubnis angekreuzt:
"Tierarzneimittel: Pkt. 3.1.5 Narkotika oder psychotrope Stoffe; Pkt. 3.1.6 Arzneimittel für Lebensmitteltiere"
zu 3.1.5: vorbehaltlich einer entsprechenden Erlaubnis nach § 3 BtMG

Reason for Withdrawing:

has been replaced by a new wholesale distribution authorisation, dated june 4, 2024 (number DE_SN_01_WDA_2024_0011)

Ist durch eine neue Großhandelserlaubnis, datiert vom 4. Juni 2024 mit der Nummer DE_SN_01_WDA_2024_0011, ersetzt worden.

Union Format for a Wholesale Distribution Authorisation	DE_SN_01_WDA_2023_0010
	Page 1

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