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RTF Template


Regierung Von Oberfranken

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

ROF-SG55.2-2675.1-40-6-5

2. Name of Authorisation Holder

:

Hoega-Pharm GmbH

(ORG-100056478 / LOC-100101224)

3. Address(es) of Site(s)

:

Gutmaninger Strasse 17, Janahof, Cham, 93413, Germany 




4. Legally registered address of Authorisation Holder

:

Gutmaninger Strasse 17, Janahof, Cham, 93413

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

:

2026-01-26

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: Hoega-Pharm GmbH

(ORG-100056478 / LOC-100101224)

, Gutmaninger Strasse 17, Janahof, Cham, 93413, 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):  Skin and hand disinfectants; infusion solutions in containers of at least 500ml

Haut- und Händedesinfektionsmittel; Infusionslösungen in Behältnissen mit mindestens 500ml















Union Format for a Wholesale Distribution Authorisation

ROF-SG55.2-2675.1-40-6-5


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