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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/517-02.13/01,0335
2. Name of Authorisation Holder	:	G.L. Pharma Deutschland GmbH
3. Address(es) of Site(s)	:	Van-der-Smissen-Str. 1, Hamburg, Hamburg, 22767, Germany

4. Legally registered address of Authorisation Holder	:	Van-der-Smissen-Str. 1, Hamburg, Hamburg, 22767, 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	:	2019-10-10
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: G.L. Pharma Deutschland GmbH

, Van-der-Smissen-Str. 1, Hamburg, Hamburg, 22767, 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 is outsourced, see annex 2 of the official documentLagerung bei einem beauftragten Betrieb, siehe Anlage 2 der Urkunde

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

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

*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/517-02.13/01,0335
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