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RTF Template

Landesamt Fuer Soziale Dienste Schleswig Holstein

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_SH_01_WDA_2023_0005
2. Name of Authorisation Holder	:	Photonamic GmbH & Co. KG
3. Address(es) of Site(s)	:	Eggerstedter Weg 12, Pinneberg, 25421, Germany

4. Legally registered address of Authorisation Holder	:	Eggerstedter Weg 12, Pinneberg, 25421
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	:	2023-04-17
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: Photonamic GmbH & Co. KG

, Eggerstedter Weg 12, Pinneberg, 25421, 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

2.3. Supply

2.4. Export

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 companys:

Medac Gesellschaft für klinische Spezialpräparate mbH
Site address: Wilfried-Mohr-Straße 1-5, 25436 Tornesch, Germany

CPL Pharma Lager und Vertrieb GmbH
Betriebsstätte:
Am Kautzgrund 14, 36103 Flieden, Germany

Ausgegliederte Tätigkeiten: Lagerung der Arzneimittel

Beauftragte Firmen:

Medac Gesellschaft für klinische Spezialpräparate mbH
Betriebsstätte:
Wilfried-Mohr-Straße 1-5, 25436 Tornesch

CPL Pharma Lager und Vertrieb GmbH
Betriebsstätte:
Am Kautzgrund 14, 36103 Flieden

*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_2023_0005
	Page 1

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