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RTF Template


Trade And Industry Inspection Agency Of State Of Lower Saxony

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products


1. Authorisation Number

:

DE_NI_03_WDA_2023_0004

2. Name of Authorisation Holder

:

Vetshop Süderelbe GmbH

(ORG-100042857 / LOC-100070833)

3. Address(es) of Site(s)

:

Gustav-Becker-Straße 20a, Emmelndorf, Seevetal, Lower Saxony, 21218, Germany 




4. Legally registered address of Authorisation Holder

:

Gustav-Becker-Straße 20a, Emmelndorf, Seevetal, Lower Saxony, 21218

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
Art. 99 of Regulation (EU) 2019/6

7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2023-07-12

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: Vetshop Süderelbe GmbH

(ORG-100042857 / LOC-100070833)

, Gustav-Becker-Straße 20a, Emmelndorf, Seevetal, Lower Saxony, 21218, Germany   



Human medicinal products

Veterinary 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 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.3. Immunological medicinal products 




Any restrictions or clarifying remarks (for all users):  According to site plan "Grundriss UG" und "Grundriss OG", both dated 2021.06.17
To 3.1 No procurement of human medical products with serialization

Gemäß den vorliegenden lageplänen "Grundriss UG" und " Grundriss OG", jeweils 17.06.2021
Zu 3.1: Keine Beschaffung und Abgabe von serialisierungspflichtigen Humanarzneimitteln



*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_NI_03_WDA_2023_0004


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