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RTF Template


Regional Council Darmstadt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

DE_HE_01_WDA_2018_0090

2. Name of Authorisation Holder

:

KREPHA GmbH & Co.KG Vertrieb für Pharma- und Diätprodukte

3. Address(es) of Site(s)

:

Schönauer Straße 32, Neckarsteinach, Hessen, 69239, Germany 




4. Legally registered address of Authorisation Holder

:

Schönauer Straße 32, Neckarsteinach, Hessen, 69239, 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

:

2018-10-05

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: KREPHA GmbH & Co.KG Vertrieb für Pharma- und Diätprodukte

, Schönauer Straße 32, Neckarsteinach, Hessen, 69239, Germany   




1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 

   2.3. Supply 

   2.5. Other activities(s): holding and supply as an outsourced activity by a Contract Company (see Annex 5)Lagerung und Lieferung (Abgabe durch einen beauftragten Betrieb (Anlage 5)



Any restrictions or clarifying remarks (for all users):  none

keine



*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_HE_01_WDA_2018_0090


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