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RTF Template

Regierung Von Oberbayern

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BY_04_WDA_2023/ROB-55Ph- 2678.Ph_2-55-23-9
2. Name of Authorisation Holder	:	Klinge Pharma GmbH (ORG-100001495 / LOC-100016782)
3. Address(es) of Site(s)	:	Bergfeldstrasse 9, Foeching, Holzkirchen, Bavaria, 83607, ALLEMAGNE

4. Legally registered address of Authorisation Holder	:	Bergfeldstrasse 9, Foeching, Holzkirchen, Bavaria, 83607
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	:	2023-12-11
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: Klinge Pharma GmbH

(ORG-100001495 / LOC-100016782)

, Bergfeldstrasse 9, Foeching, Holzkirchen, Bavaria, 83607, ALLEMAGNE

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

2.4. Export

Any restrictions or clarifying remarks (for all users): Re 2.2: Storage by external storage service providers (see Annex 2)
Re 2:4: Ketoconazole blade 20 mg/g shampoo to PR China

Zu 2.2: Lagerung erfolgt durch externe Lagerdienstleister (s. Anlage 2)
Zu 2:4: Ketoconazol Klinge 20 mg/g Shampoo nach VR China

*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_BY_04_WDA_2023/ROB-55Ph- 2678.Ph_2-55-23-9
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