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RTF Template

RegierRegierungspraesidium Tuebingen - Referat 25: Übrige Pharmazeutische Bereicheungspraesidium Tuebingen - Referat 25: Übrige Pharmazeutische Bereiche

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_BW_05_WDA_2018_0015
2. Name of Authorisation Holder	:	Daniel Groz Soehne GmbH & Co. KG
3. Address(es) of Site(s)	:	Gruengrabenstraße 52-54, Albstadt, 72458, Germany

4. Legally registered address of Authorisation Holder	:	Gruengrabenstraße 52-54, Albstadt, 72458, Germany
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2011-03-11
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: Daniel Groz Soehne GmbH & Co. KG

, Gruengrabenstraße 52-54, Albstadt, 72458, Germany

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): the wholesale authorisation comprises medicinal products for human use regulated in § 2 par. 1 Medicinal Products Act (AMG) and includes the decanting, the packaging and the labelling of medicinal products in unchanged manner and if the medicinal products are not intended for the contribution to customers

die Erlaubnis ist gültig für Humanarzneimittel im Sinne von § 2 Abs. 1 AMG und gilt auch für das Umfüllen, Abpacken oder Kennzeichnen von Arzneimitteln in unveränderter Form, soweit es sich nicht um zur Abgabe an den Verbraucher bestimmte Packungen handelt

*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_BW_05_WDA_2018_0015
	Page 1

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