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RTF Template

Landesamt für soziale Dienste Schleswig-Holstein

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_SH_01_WDA_2021_0016
2. Name of Authorisation Holder	:	FLENS Pharma GmbH
3. Address(es) of Site(s)	:	An der Krusau 5, Harrislee, 24955, Germany

4. Legally registered address of Authorisation Holder	:	An der Krusau 5, Harrislee, 24955, Germany
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-10-18
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: FLENS Pharma GmbH

, An der Krusau 5, Harrislee, 24955, Germany

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

Any restrictions or clarifying remarks (for all users): National legal basis of authorisation:
Section 52a (1) German Drug Law (Arzneimittelgesetz - AMG)

Outsourced activities: storage of medicinal products
Contract company:
Juta Pharma GmbH
Site adress:
Gutenbergstraße 13
24941 Flensburg
Germany

Outsourced activities: storage of medicinal products, including narcotic or psychotropic products
Contract company:
adjupharm GmbH
Site adress:
Lily-Braun-Straße 48,
23843 Bad Oldesloe
Germany

*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_SH_01_WDA_2021_0016
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