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RTF Template

Freie und Hansestadt Hamburg, Ministry of Health and Consumer Protection

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_HH_01_WDA/517-02.13/01,0097
2. Name of Authorisation Holder	:	ORION Pharma GmbH
3. Address(es) of Site(s)	:	Jürgen-Töpfer-Straße 46, Hamburg, 22763, Germany

4. Legally registered address of Authorisation Holder	:	Jürgen-Töpfer-Straße 46, Hamburg, 22763, 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	:	2019-11-29
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: ORION Pharma GmbH

, Jürgen-Töpfer-Straße 46, Hamburg, 22763, 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

2.5. Other activities(s): holding as an outsourced activity in an external warehouse (s. Annex 5)Lagerung bei einem beauftragten Betrieb (s. Anlage 5)

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

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_HH_01_WDA/517-02.13/01,0097
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