Austrian Federal Office For Safety In Health Care
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
483905
2. Name of Authorisation Holder
Novartis Pharma GmbH
(ORG-100000218 / LOC-100045276)
3. Address(es) of Site(s)
Logistikzentrum Wien Nord, Dietersdorfer Strasse 10-18, Hagenbrunn, Niederoesterreich, 2201, Austria
4. Legally registered address of Authorisation Holder
Jakov-Lind-Strasse 5, Top 3.05, Leopoldstadt, Vienna, 1020
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
2020-10-07
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: Novartis Pharma GmbH
(ORG-100000218 / LOC-100075679)
, Logistikzentrum Wien Nord, Dietersdorfer Strasse 10-18, Hagenbrunn, Niederoesterreich, 2201, Austria
Human medicinal products
1.1. with a Marketing Authorisation or registration in EEA country(s)
2.1. Procurement
2.2. Holding
2.3. Supply
2.4. Export
Any restrictions or clarifying remarks (for all users): Novartis Pharma GmbH - Außenlager SCHACHINGER pharmalogistik GmbH; Keine /none
Novartis Pharma GmbH - Außenlager SCHACHINGER pharmalogistik GmbH; Keine /none
Reason for Withdrawing:
The licence issued in accordance with § 63 para 1 or § 63a para 2 or 3 or § 65 para 1 shall become void if the operating licence holder relinquishes it (austrian medicinal products act).
Union Format for a Wholesale Distribution Authorisation
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