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RTF Template

Landesamt Fuer Arbeitsschutz Verbraucherschutz Und Gesundheit

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	G3-6300-GH/Dr.Butze/02/21.06.2021
2. Name of Authorisation Holder	:	Dr. Butze GmbH & Co. KG (ORG-100022342 / LOC-100042486)
3. Address(es) of Site(s)	:	Teichwiesenweg 8, Kolkwitz/ OT Babow, 03099, Germany

4. Legally registered address of Authorisation Holder	:	Teichwiesenweg 8, Babow, Kolkwitz, Brandenburg, 03099
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	:	2021-06-21
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: Dr. Butze GmbH & Co. KG Niederlassung Brandenburg

, Teichwiesenweg 8, Kolkwitz/ OT Babow, 03099, 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): The wholesale permission is limited to distribution of skin disinfection and infusion solution (from 500 ml)

This authorisation is based on floor plan Butze1 hall 5 / 2012-03-26, Butze2 / 2012-03-26

Die Großhandelserlaubnis ist auf den Vertrieb von Hautdesinfektion und Infusionslösungen (ab 500 ml) beschränkt.

Die Großhandelserlaubnis basiert auf dem Grundrissplan
Nr.: Butze 1-Halle 5 Stand vom 26.03.2012
Nr.: Butze 2-Auszug aus dem Liegenschaftskataster Stand vom 26.03.2012

Union Format for a Wholesale Distribution Authorisation	G3-6300-GH/Dr.Butze/02/21.06.2021
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