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RTF Template


Regierungspraesidium Karlsruhe

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products


1. Authorisation Number

:

DE_BW_03_WDA_2023_0001

2. Name of Authorisation Holder

:

Noweda GmbH & Co. KG

(ORG-100024835 / LOC-100055226)

3. Address(es) of Site(s)

:

Pfalzgraf-Otto-Strasse 40, Mosbach, Baden-Wuerttemberg, 74821, Germany 




4. Legally registered address of Authorisation Holder

:

Pfalzgraf-Otto-Strasse 40, Mosbach, Baden-Wuerttemberg, 74821

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

:

2023-03-17

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: Noweda GmbH & Co. KG

(ORG-100024835 / LOC-100055226)

, Pfalzgraf-Otto-Strasse 40, Mosbach, Baden-Wuerttemberg, 74821, 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 


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 

   3.2. Medicinal gases 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  to 3.1.1 subject to a corresponding permit according to § 3 German Narcotis Act

Zu 3.1.1 vorbehaltlich einer entsprechenden Erlaubnis nach § 3 BtMG



*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_03_WDA_2023_0001


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