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RTF Template


Regional Council Darmstadt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

DE_HE_01_WDA_2022_0026

2. Name of Authorisation Holder

:

Nimbus Health GmbH

(ORG-100033571 / LOC-100052575)

3. Address(es) of Site(s)

:

Otto-Scheugenpflug-Strasse 2, Bieber, Offenbach Am Main, Hassia, 63073, Germany 




4. Legally registered address of Authorisation Holder

:

Otto-Scheugenpflug-Strasse 2, Bieber, Offenbach Am Main, Hassia, 63073, Germany

5. Scope of authorisation (complete for each site under 4)

:

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 wholesaling authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2022-06-27

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: Nimbus Health GmbH

(ORG-100033571 / LOC-100052575)

, Otto-Scheugenpflug-Strasse 2, Bieber, Offenbach Am Main, Hassia, 63073, Germany   



Human medicinal products


1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation in EEA country(s)

   1.2. without a Marketing Authorisation in the EEA and intended for EEA market


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 

   2.5. Other activities(s): decanting, packaging or labelling of medicinal products without altering them and see annex 2Umfüllen, Abpacken und Kennzeichnen von Arzneimitteln in unveränderter Form und siehe Anlage 2


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 




Any restrictions or clarifying remarks (for all users):  none

keine



*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_HE_01_WDA_2022_0026


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