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RTF Template

Regierungspraesidium Darmstadt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_HE_01_WDA_2023_0036
2. Name of Authorisation Holder	:	GLS Logistik GmbH & Co. Dental Handel KG (ORG-100036354 / LOC-100078779)
3. Address(es) of Site(s)	:	Richard-Roosen-Strasse 10, Waldau, Kassel, 34123, Germany Falderbaumstrasse 7b, Waldau, Kassel, 34123, Germany

4. Legally registered address of Authorisation Holder	:	Richard-Roosen-Strasse 10, Waldau, Kassel, 34123
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-05-23
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: GLS Logistik GmbH & Co. Dental Handel KG

(ORG-100036354 / LOC-100078779)

, Richard-Roosen-Strasse 10, Waldau, Kassel, 34123, 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

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

Name and address of the site: GLS Logistik GmbH & Co. Dental Handel KG

(ORG-100036354 / LOC-100057476)

, Falderbaumstrasse 7b, Waldau, Kassel, 34123, 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

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation	DE_HE_01_WDA_2023_0036
	Page 1

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