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RTF Template


Landesdirektion Sachsen LDS

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

DE_SN_01_WDA_2023_0012 / 26-5117/316

2. Name of Authorisation Holder

:

Med! Per Tante GmbH

(ORG-100047195 / LOC-100077941)

3. Address(es) of Site(s)

:

Carl-Thieme-Strasse 10, Freital, 01705, Germany 




4. Legally registered address of Authorisation Holder

:

Carl-Thieme-Strasse 10, Freital, 01705

5. Scope of authorisation (complete for each site under 4)

:

ANNEX 1

6. Legal basis of authorisation

:

§ 52 a Absatz 1 des Gesetzes über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG) in gültiger Fassung

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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2023-08-28

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: Med! Per Tante GmbH

(ORG-100047195 / LOC-100077941)

, Carl-Thieme-Strasse 10, Freital, 01705, 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 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  This permit is valid only for drop shipment trade (trade without storage). The physical handling of medicines is not allowed. Transportation of medicines is not under the responsibility of the permit holder

Diese Erlaubnis gilt nur für den Handel im Streckengeschäft (Handel ohne Lagerung). Der physische Umgang mit Arzneimitteln ist nicht erlaubt. Der Transport der Arzneimittel erfolgt nicht unter der Verantwortung des Erlaubnisinhabers.



*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_SN_01_WDA_2023_0012 / 26-5117/316


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