Regional Council Darmstadt
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
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
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
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site: Nimbus Health GmbH
, Otto-Scheugenpflug-Strasse 2, Bieber, Offenbach Am Main, Hassia, 63073, Germany
Human 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
2.1. 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
3.1.1. 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
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