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RTF Template


Department of drug and pharmacy supervision

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

DE_ST_01_WDA_2021_003

2. Name of Authorisation Holder

:

Sandy Spengler, Transporte, Gase & Gartengeräte-Service

3. Address(es) of Site(s)

:

Alte Schäferei 2, Schkopau, 06258, Germany 




4. Legally registered address of Authorisation Holder

:

Alte Schäferei 2, Schkopau, 06258, 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

:

2021-05-26

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: Sandy Spengler, Transporte, Gase & Gartengeräte-Service

, Alte Schäferei 2, Schkopau, 06258, 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 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Medicinal gases 




Any restrictions or clarifying remarks (for all users):  - National legal basis of authorisation: Section 52a (1) German Drug Law (Arzneimittelgesetz - AMG),
- ref. 1.1: only medicinal gases,
- wholesale activities in the premises according to the present site plan Nr. 1 from 26.05.2021.

- Nationale Rechtsgrundlage für die Erlaubnis: § 52a (1) Arzneimittelgesetz (AMG),
- zu 1.1: nur medizinische Gase,
- Großhandelsaktivitäten in den Räumen gemäß dem genehmigten Lageplan Nr. 1 vom 26.05.2021.



*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_ST_01_WDA_2021_003


Page 1





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