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RTF Template


Ministry Of Social Affairs Health Women And Family

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products


1. Authorisation Number

:

DE_SL_01_WDA_2025_0015/ 5011-032

2. Name of Authorisation Holder

:

GPW Group GmbH

(ORG-100016693 / LOC-100098802)

3. Address(es) of Site(s)

:

Alt, Untertuerkheimer Strasse 15, Alt-Saarbruecken, Saarbruecken, 66117, Germany 

Kiebitzhoern 5-9, Barsbuettel, 22885, Germany 




4. Legally registered address of Authorisation Holder

:

Alt, Untertuerkheimer Strasse 15, Alt-Saarbruecken, Saarbruecken, 66117

5. Scope of authorisation

:

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 wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2025-10-02

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: GPW Group GmbH

(ORG-100016693 / LOC-100098802)

, Alt, Untertuerkheimer Strasse 15, Alt-Saarbruecken, Saarbruecken, 66117, Germany   



Human medicinal products

Veterinary medicinal products


1. MEDICINAL PRODUCTS

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

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

   1.3. without a Marketing Authorisation or registration 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

   3.2. Products requiring low temperature handling 




Name and address of the site: GPW Group GmbH

(ORG-100016884 / LOC-100093907)

, Kiebitzhoern 5-9, Barsbuettel, 22885, Germany   



Human medicinal products

Veterinary medicinal products


1. MEDICINAL PRODUCTS

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

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

   1.3. without a Marketing Authorisation or registration 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

   3.2. Products requiring low temperature handling 




Any restrictions or clarifying remarks (for all users):  The site in Barsbüttel is a dependent site

Bei der Betriebsstätte in Barsbüttel handelt es sich um eine unselbständige Betriebsstätte



*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.













Union Format for a Wholesale Distribution Authorisation

DE_SL_01_WDA_2025_0015/ 5011-032


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