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RTF Template


Staatliches Gewerbeaufsichtsamt Braunschweig

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products


1. Authorisation Number

:

DE_NI_01_WDA_2023_0002

2. Name of Authorisation Holder

:

Med-X-Press GmbH

3. Address(es) of Site(s)

:

Pracherstieg 1, Baßgeige, Goslar, Lower Saxony, 38644, Germany 

Alte Heerstraße 41, Baßgeige, Goslar, Lower Saxony, 38644, Germany 

Alte Heerstraße 1, Baßgeige, Goslar, Lower Saxony, 38644, Germany 

Dörntener Straße 21, Baßgeige, Goslar, Lower Saxony, 38644, Germany 

Alte Heerstrasse 9, Bassgeige, Goslar, Lower Saxony, 38644, Germany 




4. Legally registered address of Authorisation Holder

:

Pracherstieg 1, Goslar, Niedersachsen, 38644

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

:

2023-05-08

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-X-Press GmbH

(ORG-100011714 / LOC-100019377)

, Pracherstieg 1, Baßgeige, Goslar, Lower Saxony, 38644, 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 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.2. Medicinal products derived from blood 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Name and address of the site: Med-X-Press GmbH

(ORG-100011714 / LOC-100071375)

, Alte Heerstraße 41, Baßgeige, Goslar, Lower Saxony, 38644, 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 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.2. Medicinal products derived from blood 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Name and address of the site: Med-X-Press GmbH

(ORG-100011714 / LOC-100071455)

, Alte Heerstraße 1, Baßgeige, Goslar, Lower Saxony, 38644, 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 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.2. Medicinal products derived from blood 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Name and address of the site: Med-X-Press GmbH

(ORG-100011714 / LOC-100071456)

, Dörntener Straße 21, Baßgeige, Goslar, Lower Saxony, 38644, 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 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.2. Medicinal products derived from blood 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Name and address of the site: Med-X-Press GmbH

(ORG-100011714 / LOC-100075998)

, Alte Heerstrasse 9, Bassgeige, Goslar, Lower Saxony, 38644, 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 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.2. Medicinal products derived from blood 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 





*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_01_WDA_2023_0002


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