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RTF Template


Regierungspraesidium Tuebingen, Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

DE_BW_01_WDA_2019_0001_DRK_BSD_Mannheim

2. Name of Authorisation Holder

:

Deutsches Rotes Kreuz Blutspendedienst Baden-Württemberg-Hessen gGmbH

3. Address(es) of Site(s)

:

Friedrich-Ebert-Str. 107, Mannheim, 68167, Germany 

Im Neuenheimer Feld 583, Heidelberg, 69120, Germany 

Im Neuenheimer Feld 582, Heidelberg, 69120, Germany 

Theodor-Kutzer-Ufer 1-3, Mannheim, 68167, Germany 




4. Legally registered address of Authorisation Holder

:

Friedrich-Ebert-Str. 107, Mannheim, 68167, 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

:

2019-01-14

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: Deutsches Rotes Kreuz Blutspendedienst Baden-Württemberg-Hessen gGmbH

, Friedrich-Ebert-Str. 107, Mannheim, 68167, Germany   




1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation in EEA country(s)

   1.2. without a Marketing Authorisation in the EEA and intended for EEA market

   1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.2. Medicinal products derived from blood 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  The storage and transport of cold chain medicines are limited to medicines derived from blood.

Die Lagerung und der Transport von kühlkettenpflichtigen Arzneimitteln sind auf Arzneimittel aus Blut beschränkt.


Name and address of the site: DRK MA – Institut für Klinische Transfusionsmedizin und Zelltherapie

, Im Neuenheimer Feld 583, Heidelberg, 69120, Germany   




1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation in EEA country(s)

   1.2. without a Marketing Authorisation in the EEA and intended for EEA market

   1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.2. Medicinal products derived from blood 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  The storage and transport of cold chain medicines are limited to medicines derived from blood.

Die Lagerung und der Transport von kühlkettenpflichtigen Arzneimitteln sind auf Arzneimittel aus Blut beschränkt.


Name and address of the site: DRK MA - Stammzelllabor

, Im Neuenheimer Feld 582, Heidelberg, 69120, Germany   




1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation in EEA country(s)

   1.2. without a Marketing Authorisation in the EEA and intended for EEA market

   1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.2. Medicinal products derived from blood 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  The storage and transport of cold chain medicines are limited to medicines derived from blood.

Die Lagerung und der Transport von kühlkettenpflichtigen Arzneimitteln sind auf Arzneimittel aus Blut beschränkt.


Name and address of the site: DRK MA - Klinikum Mannheim - Blutbank und Labor

, Theodor-Kutzer-Ufer 1-3, Mannheim, 68167, Germany   




1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation in EEA country(s)

   1.2. without a Marketing Authorisation in the EEA and intended for EEA market

   1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.2. Medicinal products derived from blood 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  The storage and transport of cold chain medicines are limited to medicines derived from blood.

Die Lagerung und der Transport von kühlkettenpflichtigen Arzneimitteln sind auf Arzneimittel aus Blut beschränkt.



*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_01_WDA_2019_0001_DRK_BSD_Mannheim


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