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RTF Template

Hessian Office For Health And Care

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_HE_01_WDA_2025_0005
2. Name of Authorisation Holder	:	Orthegroh eG (ORG-100053929 / LOC-100095351)
3. Address(es) of Site(s)	:	Berliner Strasse 50, Homberg (Ohm), 35315, Germany

4. Legally registered address of Authorisation Holder	:	Fockestrasse 25/1, Laupheim, Baden-Wuerttemberg, 88471, Germany
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Sect 52a para 1 German Medicinal Product Act
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-03-14
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: Orthegroh eG

(ORG-100053929 / LOC-100095392)

, Berliner Strasse 50, Homberg (Ohm), 35315, 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

2.2. Holding

2.3. Supply

Any restrictions or clarifying remarks (for all users): The original, paper-based WDA also includes medical gases under point 3.2.

Die originale, papierbasierte Erlaubnis beinhaltet unter Punkt 3.2 auch Medizinische Gase.

Union Format for a Wholesale Distribution Authorisation	DE_HE_01_WDA_2025_0005
	Page 1

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