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RTF Template

Behoerde Fuer Gesundheit Und Verbraucherschutz Der Freien Und Hansestadt Hamburg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_HH_01_WDA/517-02.13/01,0477
2. Name of Authorisation Holder	:	Siglos GmbH (ORG-100052614 / LOC-100092657)
3. Address(es) of Site(s)	:	Hermannstrasse 16, Hamburg-Altstadt, Hamburg, 20095, Germany

4. Legally registered address of Authorisation Holder	:	Hermannstrasse 16, Hamburg-Altstadt, Hamburg, 20095, Germany
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-03-19
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: Siglos GmbH

(ORG-100052614 / LOC-100092657)

, Hermannstrasse 16, Hamburg-Altstadt, Hamburg, 20095, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

2.5. Other activities(s): (please specify) storage at a contracted companyLagerung bei einem beauftragten Betrieb

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.3. Other products: (please specify here or make a reference to Annex 5) medicinal gases Medizinische Gase

Any restrictions or clarifying remarks (for all users): storage at contracted company: Positio Pharma GmbH & Co. KG, Neßlerstr. 27, 40593 Düsseldorf

Lagerung bei beauftragtem Betrieb: Positio Pharma GmbH & Co. KG, Neßlerstr. 27, 40593 Düsseldorf

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

Union Format for a Wholesale Distribution Authorisation	DE_HH_01_WDA/517-02.13/01,0477
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