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RTF Template

Landesverwaltungsamt Sachsen-Anhalt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_ST_01_WDA_2023_004
2. Name of Authorisation Holder	:	Witt-Reinigungsbedarf, Fachgrosshandlung Fur Sauberkeit Und Hygiene GmbH (ORG-100036155 / LOC-100057201)
3. Address(es) of Site(s)	:	Ohrestrasse 16 - 18, Neue Neustadt, Magdeburg, Saxony-Anhalt, 39124, Germany

4. Legally registered address of Authorisation Holder	:	Ohrestrasse 16 - 18, Neue Neustadt, Magdeburg, Saxony-Anhalt, 39124
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	:	2023-02-09
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: Witt-Reinigungsbedarf, Fachgrosshandlung Fur Sauberkeit Und Hygiene GmbH

(ORG-100036155 / LOC-100057201)

, Ohrestrasse 16 - 18, Neue Neustadt, Magdeburg, Saxony-Anhalt, 39124, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation 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): National legal basis of the authorisation: Section 52a (1) German Drug Law (AMG)
ref. 1.1: only skin and hand disinfectants
The authorisation based on the confirmed layout plans dated 19/10/2012.

Nationale Rechtsgrundlage der Erlaubnis: § 52a (1) Arzneimittelgesetz (AMG)
zu 1.1: nur Haut- und Händedesinfektionsmittel
Die Erlaubnis basiert auf dem bestätigten Grundrissplan vom 19.10.2012.

Union Format for a Wholesale Distribution Authorisation	DE_ST_01_WDA_2023_004
	Page 1

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