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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 and Veterinary medicinal products

1. Authorisation Number	:	DE_HH_01_WDA/517-02.13/01,0266
2. Name of Authorisation Holder	:	Cheiron Pharma GmbH
3. Address(es) of Site(s)	:	Oberhafenstraße 1, Hamburg, Hamburg, 20097, Germany

4. Legally registered address of Authorisation Holder	:	Oberhafenstraße 1, Hamburg, Hamburg, 20097
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-11-03
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: Cheiron Pharma GmbH

, Oberhafenstraße 1, Hamburg, Hamburg, 20097, Germany

Human medicinal products

Veterinary 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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

Any restrictions or clarifying remarks (for all users): 3.1.1: subject to a permission according to sect. 3 Betäubungsmittelgesetz (Narcotic Drug Act)

Zu 3.1.1: vorbehaltlich einer entsprechenden Erlaubnis nach § 3 Betäubungsmittelgesetz

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

Union Format for a Wholesale Distribution Authorisation	DE_HH_01_WDA/517-02.13/01,0266
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